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A cohort study assessing the feasibility of an RCT and acceptability

and preliminary efficacy of a guided brief Mindfulness-Based

Intervention for Sleep Disturbance in Dementia

by

Melody Smith

Submitted in partial fulfilment of the degree of

Doctor of Psychology

(Clinical Psychology)

School of Psychology

Faculty of Health and Medical Sciences

University of Surrey

Guildford, Surrey

United Kingdom

September 2019

© Melody Smith 2019

Abstract

Objectives: Sleep disturbance (SDi) is common in people with

dementia (PwD) and impairs cognitive, psychological and functional

wellbeing. Pharmacological treatments have serious side-effects. There is

a lack of non-pharmacological treatment guidance and provision. Guided

brief Mindfulness-Based interventions (gbMBIs) are effective in alleviating

SDi in adults and are pragmatic to deliver. This study primarily explored: 1)

the feasibility of a randomised controlled trial (RCT) investigating the

efficacy of a gbMBI in alleviating SDi in dementia; and 2) the acceptability

of a gbMBI among dyads comprising the person with dementia and their

caregiver. Secondarily, it assessed the preliminary efficacy of a gbMBI.

Design: Uncontrolled cohort study; all dyads received the gbMBI.

Method: Dyads (N=9) received Good Sleep Hygiene guidance

(GSH) and PwD undertook a 1-week, nightly, 14-minute audio gbMBI.

Quantitative data were used to assess feasibility of an RCT and mixed-

method data for the acceptability and preliminary efficacy of the gbMBI.

This study was exploratory and therefore no inferential analyses were

performed. A modified mixed-method triangulation protocol unified mixed-

method data.

Results: Although research registers identified large pools of

potential dyads, the eligibility rate did not exceed that of successful RCTs,

whereas retention and adherence rates did.

Triangulated data suggested the gbMBI delivery and content was

acceptable to most, although some suggestions for improvement were

recommended. Greater emphasis on GSH may increase acceptability. The

gbMBI conflicted with the values of 2 dyads.

Triangulated data provided some results suggesting alleviation of

SDi and some that did not.

Conclusions: An RCT may be feasible based on retention and

adherence rates, but not eligibility rates; the gbMBI was acceptable among

many dyads, but not all; the preliminary efficacy of the gbMBI was

inconclusive. Overall, this study justified further development research into

the efficacy of a gbMBI in treating SDi in dementia.

Acknowledgements

Clinical training has been a long and winding road. I thank God for

keeping me on this journey.

I would like to thank my supervisors Paul Davis and Becky Gould

for their unwavering support and guidance in conducting this research and

with writing up my thesis. Thank you also to Emma Williams and Paul

Hanna for helping me grow as a qualitative researcher. Thank you to Nan,

my tutor, for your support.

I would like to express gratitude to Sharon Galliford and the Service

User and Carers Advisory Group for their guidance in developing the

study. I am also grateful to David Williams, Josephine Roland and Victoria

Hill for their belief in my research, for welcoming me to team meetings and

allowing me to offer participation to their patients. Thank you to their

colleagues at Croydon Memory Service, Surrey and Borders Older

People’s Community Mental Health Service and Sutton Older People’s

Services, respectively, for referring potential participants. Also, to Clare

Shaw and Emma Maker who facilitated access to the Join Dementia

Research register and Megan Pritchard who facilitated access to the

consent for contact register. Thank you to all the people with dementia and

study partners who showed an interest in this study. To the dyads who

took part in this study, without you it would not have been possible, and I

am deeply grateful for the efforts you spent participating in the study.

Thank you for your openness. I wish you all the very, very best for your

futures.

Lastly, I would like to thank Monica Smith for being my rock since

day one. Hysha Smith, thank you for being the one who has always

boosted my confidence the most. Meshach Smith, thank you for never

failing to remind me that patience is a virtue and that laughter is the best

medicine. To Tahira and Ahmed Hassan, I thank you for your support,

understanding and kind words of encouragement. Khalid Hassan thank

you hugely for enduring this journey with me. Thank you most for

encouraging me achieve balance between work and life. And lastly to

Marley Smith Hassan (and any siblings you may have in the future), I

always had you in mind. Thank you for being my motivation. Find your

motivation, work hard and smart and for long enough, and you will achieve

amazing things. Because if mummy can do it, you certainly can, too!

This thesis is dedicated to Orelle Boreland (27/11/1980-

19/03/2016). Your dedication to uplifting the next generation was truly

inspirational.

Table of Contents

ABSTRACT................................................................................................................................ II

ACKNOWLEDGEMENTS............................................................................................................ IV

TABLE OF CONTENTS............................................................................................................... VI

PART 1: MRP EMPIRICAL PAPER................................................................................................9

INTRODUCTION...................................................................................................................... 10

SLEEP DISTURBANCE (SDI) IN DEMENTIA.............................................................................................11CURRENT TREATMENT OF SDI IN DEMENTIA........................................................................................11NON-PHARMACOLOGICAL INTERVENTIONS (NPIS)................................................................................12MIND-BODY TREATMENTS FOR SDI IN DEMENTIA.................................................................................14MINDFULNESS-BASED INTERVENTIONS (MBIS).....................................................................................15MBIS IN PEOPLE WITH DEMENTIA (PWD)...........................................................................................16GUIDED BRIEF MBIS (GBMBIS)........................................................................................................17THE CURRENT STUDY.......................................................................................................................18PRIMARY RESEARCH QUESTIONS........................................................................................................19SECONDARY RESEARCH QUESTION......................................................................................................19

METHOD................................................................................................................................ 19

EPISTEMOLOGICAL POSITION.............................................................................................................19DESIGN OVERVIEW.........................................................................................................................20PARTICIPANTS................................................................................................................................20INTERVENTION...............................................................................................................................25PROCEDURE..................................................................................................................................26PRIMARY QUANTITATIVE OUTCOME DATA............................................................................................27SECONDARY QUANTITATIVE OUTCOME DATA........................................................................................28SAMPLE SIZE AND QUANTITATIVE DATA ANALYSIS..................................................................................29QUALITATIVE DATA.........................................................................................................................29QUALITATIVE DATA ANALYSIS............................................................................................................30DEDUCTION OF THEMES...................................................................................................................31MIXED-METHOD DATA TRIANGULATION..............................................................................................32ETHICAL CONSIDERATIONS................................................................................................................33

RESULTS................................................................................................................................. 33

PRIMARY QUANTITATIVE OUTCOME DATA: FEASIBILITY OF AN RCT...........................................................35PRIMARY QUANTITATIVE OUTCOME DATA: ACCEPTABILITY OF GBMBI.......................................................36SECONDARY QUANTITATIVE OUTCOME DATA: PRELIMINARY EFFICACY.......................................................36SECONDARY QUALITATIVE THEMES: PRELIMINARY EFFICACY OF THE GBMBI...............................................48MIXED-METHOD DATA TRIANGULATION..............................................................................................49

DISCUSSION............................................................................................................................ 52

SUMMARY OF RESULTS AND CLINICAL IMPLICATIONS..............................................................................53FURTHER RESEARCH........................................................................................................................59STRENGTHS AND LIMITATIONS...........................................................................................................61CONCLUSION.................................................................................................................................62

REFERENCES........................................................................................................................... 64

LIST OF APPENDICES...............................................................................................................82

APPENDICES........................................................................................................................... 83

APPENDIX 1: EPISTEMOLOGICAL POSITION AND REFLEXIVITY...................................................................84APPENDIX 2: STUDY LEAFLET/POSTER.................................................................................................89APPENDIX 3: STUDY CASE RECORD FORM............................................................................................90APPENDIX 4: GBMBI (BODY SCAN FOR SLEEP) TRANSCRIPT (13:50 MINS)..............................................135APPENDIX 5: TELEPHONE PRE-SCREENING QUESTIONNAIRE SCRIPT.........................................................141APPENDIX 6: GSH LEAFLET PROVIDED TO DYADS................................................................................145APPENDIX 7: PRINCIPLES OF QUALITY QUALITATIVE RESEARCH (YARDLEY, 2000).....................................146APPENDIX 8: INTERVIEW SCHEDULE.................................................................................................151APPENDIX 9: EARLIER THEMATIC MAP FOR ACCEPTABILITY OF GBMBI....................................................154APPENDIX 10: EARLY THEMATIC MAP FOR PERCEIVED EFFICACY OF THE GBMBI.......................................155APPENDIX 11: FURTHER ETHICAL CONSIDERATIONS.............................................................................156APPENDIX 12: A TABLE SHOWING THE REASONS FOR DYAD INELIGIBILITY BY RECRUITMENT SOURCE.............157

PART 2: LITERATURE REVIEW....................................................................................................1

ABSTRACT................................................................................................................................ 2

INTRODUCTION........................................................................................................................ 4

PHARMACOLOGICAL TREATMENTS........................................................................................................8PREVIOUS REVIEWS OF NON-PHARMACOLOGICAL INTERVENTIONS (NPIS) FOR SDI IN DEMENTIA.....................9THE CURRENT REVIEW.....................................................................................................................10

METHOD................................................................................................................................ 11

DEVELOPMENT OF SEARCH CRITERIA...................................................................................................11SELECTION OF RELEVANT STUDIES......................................................................................................14DATA EXTRACTION..........................................................................................................................15CRITIQUE OF METHODOLOGICAL QUALITY............................................................................................15REPORTING GUIDELINES...................................................................................................................16

RESULTS................................................................................................................................. 19

OVERVIEW OF STUDY CHARACTERISTICS AND DESIGNS............................................................................19PARTICIPANTS................................................................................................................................21SLEEP OUTCOMES...........................................................................................................................25EFFECTS OF INTERVENTIONS ON QUANTITATIVE SLEEP OUTCOMES............................................................25RISK OF BIAS (ROB)........................................................................................................................32

DISCUSSION............................................................................................................................ 39

SYNTHESIS OF NPI EFFICACY RESULTS AND CLINICAL IMPLICATIONS...........................................................40COMPLETENESS AND APPLICABILITY OF STUDIES DUE TO STUDY DESIGN.....................................................44CERTAINTY OF THE EVIDENCE DUE TO METHODOLOGICAL QUALITY OF STUDIES............................................49GUIDANCE FOR FUTURE RESEARCH.....................................................................................................51LIMITATIONS.................................................................................................................................52

CONCLUSION.......................................................................................................................... 54

REFERENCES........................................................................................................................... 56

PART 3: CLINICAL EXPERIENCE................................................................................................71

ADULT PLACEMENT- COMMUNITY MENTAL HEALTH RECOVERY SERVICE..................................................72CHILD PLACEMENT- CHILD AND ADOLESCENT MENTAL HEALTH SERVICE...................................................72LEARNING DISABILITY PLACEMENT- COMMUNITY LEARNING DISABILITY TEAM...........................................73SPECIALIST PLACEMENT- ADULT NEUROREHABILITATION SERVICE............................................................73OLDER ADULT PLACEMENT- COMMUNITY OLDER PEOPLE’S TEAM, BEHAVIOUR AND COMMUNICATION SUPPORT SERVICE, MEMORY ASSESSMENT SERVICE...........................................................................................74

PART 4: ASSESSMENTS............................................................................................................ 75

Part 1: MRP Empirical Paper

A cohort study assessing the feasibility of an RCT and acceptability and

preliminary efficacy of a guided brief Mindfulness-Based Intervention for Sleep

Disturbance in Dementia

Introduction

Dementia is a progressive neurodegenerative disease that impairs cognitive and

functional abilities (Lipton & Marshall, 2013). Ageing is a primary risk factor for

dementia. Accordingly, dementia prevalence has increased in parallel with the ageing

population (Prince et al., 2014). Forecasts suggest dementia prevalence will increase

from 851,000 (2015) to over 2 million by 2050 (Health and Social Care Information

Centre (HaSCIC), 2016). Dementia severity is correlated with increased need for

institutional or respite care, presenting a significant economic burden on people with

dementia (PwD), caregivers and healthcare services (Schaller et al., 2015). The

combined cost of care to the UK government, PwD and families is expected to reach

£59.3 billion by 2050 (HaSCIC, 2016).

The UK National Dementia Strategy was introduced in response to the increasing

prevalence and economic burden dementia poses (Department of Health (DoH), 2009).

It aims to address the needs of PwD by: 1) raising awareness and understanding of

dementia; 2) facilitating early diagnosis and; 3) providing provisions to help people live

well with dementia.

Up to 97% of PwD are affected by behavioural and psychological symptoms,

intensifying in parallel with cognitive decline, preventing PwD living well (Steinberg et

al., 2008). Sleep disturbance (SDi) is among the most problematic behavioural and

psychological symptoms of dementia (Kales, Gitlin & Lyketsos, 2015).

Sleep disturbance (SDi) in dementia

SDi is defined as having at least 1 of the following: significantly reduced night-

time sleep duration; subjective poor-quality sleep; or significantly increased night-time

wakefulness (Robotham, Chakkalacka & Cyhlarova, 2011). SDi is associated with

cognitive impairment, poorer subjective and objective physical, psychosocial and

psychological wellbeing and quality of life in PwD (Wennberg, Wu, Rosenberg & Spira,

2017). SDi coincides with increased distress, poorer health and quality of life in

caregivers. Therefore, SDi increases the need for institutionalisation of PwD and raises

healthcare costs to PwD, caregivers and healthcare services (Gehrman et al., 2018). To

help PwD live well, effective treatments for SDi are needed.

Current treatment of SDi in dementia

National Institute for Health and Care Excellence (NICE) guidelines for managing

sleep problems in people with dementia advises against offering melatonin to manage

insomnia in people living with Alzheimer's disease (NICE, 2018). It recommends

considertion of a personalised multicomponent sleep management approach that

includes sleep hygiene education, exposure to daylight, exercise and personalised

activities, for people with dementia who have sleep problems. Despite the impact of SDi

in dementia, the provided guidance for treating SDi in PwD is vague and limited. This is

likely due to a scarcity of high-quality research and a lack of an effective, clear

treatment protocol, deliverable in the context of the National Health Service (NHS;

Literature Review (LR) pg.62). Additionally, recruitment and attrition in studies for PwD

is challenging and likely impacts the volume of studies reported in this cohort (Watson

et al., 2014).

Pharmacological Interventions

Research suggests pharmacological interventions used to treat SDi in the

general population (e.g. hypnotics [e.g. Zopiclone], neuroleptics [e.g. Risperidone] and

benzodiazepines [e.g. Temazepam]) prompt accelerated cognitive decline, postural

unsteadiness, dependency and death in PwD (Ralph & Espinet, 2019). Preliminary

evidence supports the efficacy of low dose Trazodone (tetracylic antidepressant).

However, no research into long-term (>4 weeks) safety or benefits of this, or indeed any

medication for SDi in dementia, has been conducted (McCleery, Cohen & Sharpley,

2016). Production of sleep-inducing hormone, melatonin, is low in PwD (Skene &

Swaab, 2003). However, evidence suggests synthetic melatonin induces poor affect

and agitation in PwD, therefore NICE guidance censures its use (Haffmans, Sival &

Lucius et al., 2001).

Short- and long-term use of medications for SDi in dementia comes with risks of

serious side effects. Consequently, pharmacological interventions do not feature in

NICE guidance for treating SDi in dementia. However, in 2011 the DoH and Human

Services USA reported 14% of elderly nursing home residents were prescribed

antipsychotic drugs and 88% were for “black-label” conditions such as SDi in dementia

(Levinson, 2011). Thus, despite known risks, antipsychotics continue to be used to treat

SDi in dementia. Non-pharmacological interventions (NPIs) provide an alternative

approach to treating SDi in dementia and likely have fewer risks.

Non-Pharmacological Interventions (NPIs)

Bright light therapy (BLT) involves absorbing ambient or direct light, often from a

special lamp. It can be challenging to administer, as it requires PwD is restricted to a

predefined space for an extended period to absorb the bright light. Heterogeneity in

dosages and delivery conditions across studies mean optimal BLT is poorly understood.

Moreover, evidence for the efficacy of BLT is “inconclusive” (LR, pg.44). Accordingly, it

is not recommended in NICE guidelines. Evidence for activity interventions (e.g. 30mins

walking/day) is also “inconclusive” (LR, pg. 45).

Good Sleep Hygiene guidance (GSH) consists of a list of behavioural,

environmental and temporal practices (NICE, 2018). These practies are discussed with

the sleeper, with a view to them adopting the practices not already being followed,

leading to better sleep. Evidence suggests GSH is ineffective at alleviating SDi in

dementia as a stand-alone treatment (Schoicket, Bertelson & Lacks, 1988). However,

GSH compliments other interventions, meaning studies generally combine GSH with

other therapies to treat SDi (Taylor & Pruiksma, 2014). Dissemination of GSH is

recommended by NICE (2018).

Replicated findings suggest Nighttime Insomnia Treatment and Education for

Alzheimer’s Disease (NITE-AD; incorporates BLT, activity and Cognitive Behavioural

Therapy) effectively reduced SDi in dementia (McCurry et al., 2005; McCurry et al.,

2011). NICE guidance incorporates these findings into recommendations. However, the

high level of resources required to deliver NITE-AD (i.e. highly trained professional)

make it unfeasible to deliver in the NHS context, undermining its usefulness. Despite

the authors publishing a general outline of the sessions, there is absence of a detailed

treatment protocol, meaning effective administration of NITE-AD is unclear. Findings

from a recent trial of a manualised, intervention informed by NITE-AD, delivered by

graduate psychologists (supervised by clinical psychologists) suggest feasibility and

acceptability among PwD (Livingston et al., 2019). Thus, the development of a

deliverable multicomponent intervention is in progress; a sufficiently powered

randomised controlled trial (RCT) to assess efficacy is needed.

Research into other treatments for SDi from the wider evidence base may lead to

development of alternative treatments (Deschenes & McCurry, 2009). Recent findings

suggest mind-body treaments (e.g. mindfulness-based interventions) may be efficacious

in reducing SDi in adults and older adults with and without dementia (Winbush et al.,

2007; Black et al., 2015; Chan et al., 2016).

Mind-body treatments for SDi in dementia

Findings from 2 studies using mind-body treatments to alleviate SDi in dementia

are reported below:

An RCT exploring efficacy of Tai Chi Qigong (2 60-minute classes/week for 2

months) in reducing SDi in PwD, showed no significant improvements in sleep

immediately following engagement (Chan et al., 2016; LR, pg.45). However, at 6-month

follow-up, there were significant improvements in sleep compared with controls. It was

hypothesised that the delay in benefits was due to time taken to reach a level of

mastery in this treatment.

In a pilot study by Paller and colleagues (2015), person with dementia-caregiver

“dyads” attended an 8-week, 90-minute group programme, designed to reduce cognitive

impairment, delivered in the community. The programme resembled Mindfulness-Based

Stress Reduction and incorporated elements of Dialectical Behaviour and Acceptance

and Commitment Therapies, suggesting delivery was by a highly trained professional.

Improvements in Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989) suggested

the intervention was preliminarily efficacious in reducing SDi.

Though few, these studies provide preliminary evidence for efficacy of mind-body

treatments in alleviating SDi in PwD, justifying further research to corroborate findings.

However, mind-body treatments, require vast resources, limiting their appropriateness

for the NHS and causing a lack in such provision (Crane, Kuyken, Hastings, Rothwell &

Williams, 2010). Mindfulness-based interventions (MBIs) are mind-body treatments,

however, there is currenly no research into MBIs for SDi in dementia (Kozasa et al.,

2010). Evidence suggests traditional MBIs (tMBIs) may be successfully adapted into

pragmatic, guided brief MBIs (gbMBIs).

Mindfulness-based interventions (MBIs)

Mindfulness is defined as “awareness that emerges through paying attention on

purpose, in the present moment and non-judgmentally to the unfolding of experience

moment by moment” (Kabat-Zinn, 2003; pp. 145). MBIs are thought to create change

through building skills in self-examination, awareness, compassion and acceptance,

prompting changes in affect regulation, stress impulse reactions and behaviour (Bishop

et al., 2004).

Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy

are tMBI programmes, delivered face-to-face in groups by trained practitioners (Kabat-

Zinn, 1990; Segal, Williams & Teasdale, 2018). Both programmes run for 2-3 hours over

8 weeks (16-24hrs practitioner contact). In sessions, guided mindfulness meditation

exercises (e.g. body scans) steer participants’ attention and encourage

acknowledgement and acceptance of thoughts, emotions and bodily sensations.

Reflective discussions take place after exercises, during which learning is assimilated.

Exercises are provided on a CD and attendees are encouraged to practice mindfulness

meditation exercises at home, reinforcing skills developed in sessions.

MBIs in people with dementia (PwD)

Engagement with MBIs requires receptive language skills and sustained, directed

attention. Impairments in these skills are hallmark features of dementia, raising

questions about whether PwD can engage with MBIs (APA, 2013; Johnco, Wuthrich &

Rapee, 2013). Preliminary evidence suggests MBIs improve neuropsychological

functioning (e.g. attention, processing speed), countering this potential issue (Berk,

Warmenhoven, van Os & van Boxtel, 2018). Moreover, ability to create unconsciously

gained, implicit memories is often preserved in mild dementia (e.g. through priming,

perceptual learning; Lezak, Howieson, Bigler & Tranel, 2012; Fleischman, 2007). This

suggests people with mild dementia maintain the ability to access MBIs through

repeated exposure (Paller et al., 2015).

Research into tMBIs in dementia has started to gain momentum, but remains

limited (Chan, 2015). Several MBI studies report improved clinical outcomes in

cognitive, emotional, psychological and quality of life domains in PwD across clinical

presentations (e.g. depression; Berk, Warmenhoven, van Os & van Boxtel, 2018).

These findings ratify the notion that PwD can access and benefit from tMBIs and justify

further research into benefits of MBIs across indicated clinical presentations.

Guided brief MBIs (gbMBIs)

There is no concrete definition for gbMBIs, meaning there is heterogeneity in

gbMBIs across the evidence base. Contrary to tMBIs, in which participation is required

for several hours over several weeks (e.g. 1.5hrs/week for 8 weeks), brief MBIs are

delivered during short sessions (≤20 mins), over a short period (i.e. ≤1 week) or during

a single session. Guided MBIs represent an intermediate between self-guided MBIs (no

contact with an MBI practitioner) and tMBIs (16+hrs contact with an MBI practitioner;

McClintock, McCarrick, Garland, Zeidan & Zgierska, 2018). gbMBIs incorporate

mindfulness meditation exercises (e.g. body scan) and aim to focus attention on the

present moment non-judgementally (Kabat-Zinn, 2003). gbMBIs are delivered in a

variety of formats (e.g. via audio; Heppner and Shirk, 2018).

Evidence suggests gbMBIs are effective in improving cognition and emotional

regulation in adults (Heppner and Shirk, 2018). There is a lack in RCTs comparing

gbMBI efficacy with tMBI efficacy. Thus, it is unclear which is more efficacious.

However, meta-analyses suggest the particular mindfulness exercise used; practitioner

background and training; delivery mode (e.g. one-to-one); and session length and

setting do not reduce the efficacy of amended MBIs when compared with tMBIs

(Cavanagh, Strauss, Forder & Jones, 2014; Gellatly et al., 2007; Khoury et al., 2013).

Currently, no studies have explored the efficacy of gbMBIs in alleviating pychosocial

difficulties in PwD. However, preliminary evidence suggests a gbMBI effectively

alleviated worry in people with mild cognitive impairment (Lenze et al., 2014).

Overall, gbMBIs could provide a pragmatic (i.e. resource-light and deliverable),

effective alternative to resource-heavy, scarcely accessible treatments such as NITE-

AD and tMBIs. However, research into gbMBIs for SDi in dementia is currently non-

existent. Research is needed.

The current study

Pharmacological treatments have serious side effects and no evidence base for

long-term treatment of SDi in dementia. NPIs provide an alternative approach with fewer

side effects. While evidence suggests NITE-AD and tMBI treatments improve SDi in

PwD, they require vast resources, resulting in a lack of provision offered by the NHS. A

deliverable, manualised multicomponent intervention, based on NITE-AD, is in

development. Several studies report MBIs maintain efficacy in adults and people with

mild cognitive impairment when adapted (e.g. shorter session length). gbMBIs are

pragmatic, making them an attractive option for the NHS in delivering the National

Dementia Strategy's aim of helping PwD (and SDi) live well. There are no studies

exploring gbMBIs for SDi in dementia.

An RCT would be required to assess efficacy of a gbMBI in alleviating SDi in

dementia. However, this is a novel research area and at this juncture, a pilot study is

appropriate (Thabane et al., 2010). Consistent with Medical Research Council guidance

on developing interventions, this study primarily aimed to assess the feasibility of an

RCT delivering a gbMBI to PwD and SDi (Craig et al., 2008). Accordingly, this study

aimed to emulate an RCT, creating a representative scenario. It aimed to inform on

whether eligibility, recruitment and attrition rates, and data collection could inhibit

conduct of a successful RCT (Moore et al., 2015).

An acceptable intervention is appropriate, reasonable and convenient (Sekhon,

Cartwright & Francis, 2017). Acceptability of interventions influences applicability,

therefore, another primary aim of this study was to explore the acceptability of a gbMBI

(Craig et al., 2008). PwD often require support to engage with interventions, thus, views

of both PwD and caregivers were considered.

During this study, outcome data were collected, meaning there was an

opportunity to assess preliminary efficacy. Therefore secondarily, this study aimed to

report preliminary efficacy of a gbMBI in treating SDi in dementia.

Primary research questions

Is an RCT of a gbMBI for PwD and SDi feasible?

Is a gbMBI acceptable to PwD with SDi, and caregivers?

Secondary research question

Does a gbMBI demonstrate preliminary efficacy in treating SDi in PwD?

Method

Epistemological position

Quantitative data were used to assess RCT feasibility (Craig et al., 2008).

However, the researcher perceived quantitative and qualitative methods as

complementary. A pluralist, mixed-method approach was adopted in assessing gbMBI

acceptability and preliminary efficacy (Casebeer & Verhoef, 1997; Yardley, 1999).

Mixed-method methodology is recommended in the early evaluation of interventions

(Campbell et al., 2000). Mixed-method data provides benefits from diverse methods

while potentially compensating for their shortcomings (Teddlie & Tashakkori, 2003).

Qualitative data can provide nuanced meaning to quantitative data. This may be of

particular benefit in developing an intervention for PwD, a complex and challenging

endeavour (Watson et al., 2014). Adoption of a pluralist approach represented a shift in

the researcher’s stance, enabled experience in the challenges and strengths of mixed-

method research and evoked growth from a graduate to a doctoral level researcher.

Further reflections on the epistemological position and reflexivity of the researcher are

in Appendix 1.

Design overview

Considering the novel, investigatory nature of this study, a pragmatic

uncontrolled cohort study design was selected and delivered in a way amenable to an

RCT. This study drew from methodological blueprints of RCTs of MBIs in other cohorts

(e.g. Black, O’Reilly, Olmstead, Breen & Irwin, 2015). However, all participants received

the gbMBI due to time constraints, expected recruitment challenges and a small budget.

Recommendations for conducting research with PwD were adopted where appropriate

(e.g. study partners [SPs] were recruited alongside PwD; Watson et al., 2014;

Robertson, 2015; Chan et al., 2017).

Participants

Recruitment and eligibility criteria

Person with dementia-SP “dyads” were recruited via 3 NHS older people's

services according to inclusion and exclusion criteria (Table 1). Self-referral was

permitted, and posters and leaflets placed within the 3 services’ waiting rooms

promoted the study (Appendix 2). The researcher attended team meetings and linked

with 1 clinician in each Trust to facilitate referrals (clinicians gained consent from

potential dyads to be contacted by the researcher). Two research registries were

accessed: The “C4C register”, a London-based database, and “Join Dementia

Research”, a national register.

Demographics and clinical characteristics

Demographic and clinical characteristic data were collected via the Case Record

Form (Appendix 3) during Appointment 1 (baseline). PwD (n=9) were 53-91 years

(M=69.8, SD=24.2; Table 2). SPs (n=9) were 55-90 years (M=70.4, SD=12.9). Four of 9

PwD were female (44%); all 9 SPs were female (3 mother-daughter dyads; 6 spouse

dyads). Eight dyads identified as White British. English was the first language of all

dyads.

Table 1Inclusion and exclusion criteria for participants in this studyInclusion CriteriaPeople with dementia: Aged 55+ Diagnosed with probable or possible dementia (by a Psychiatrist) in the mild stages (sMMSE≥18)With: Capacity to give fully informed consent PSQI≥5 A SP willing to support the PwD to engage with the study. Exclusion CriteriaPeople with Dementia with: An inability to speak fluent English Previous or current experience of meditation A diagnosis of a severe, enduring mental health disorder (e.g. schizophrenia), neurological

disorder (e.g. epilepsy) or physical health problem likely to impact on sleep (i.e. heart disease, lung disease, or a nerve disorder)

A severe hearing impairment Current higher risk alcohol consumption (>4/>3 units/day for men/women respectively), substance

abuse or dependence Suicidal ideation with intent. Concurrent participation in another study or psychotherapy sMMSE: Standardised Mini-Mental State Examination; SP: Study Partner; PSQI: Pittsburgh Sleep Quality Index

All 9 PwD were diagnosed by a consultant psychiatrist, confirmed using their

medical records (Table 3). Six had a diagnosis of Alzheimer’s disease. The sMMSE, a

30-item measure assessing various cognitive domains (e.g. working memory)

determined dementia severity (Tombaugh & McIntyre, 1992). The sMMSE has high

sensitivity (85.7%-86.3%) and specificity (71.4%-100%; Pangman, Sloan & Guse,

2000). It has good content validity and high construct validity, test-retest reliability

(r=0.90-0.93), inter-rater reliability, test-retest reliability, intraclass correlations and

internal consistency (α=0.86-0.90; Pangman et al., 2000). Participants' sMMSE scores

ranged from 18 to 27 (M=22.9, SD=3.2).

Table 3

Table 2Summary of participants’ demographic informationParticipant Age (years) Sex Ethnicity Relationship

P1 90 Female White British

Mother/daughterSP1 59 Femal

e White British

P2 72 Male White BritishSpousal

SP2 81 Female White British



P4 82 Female Other


e Other






SpousalSP7 57 Femal

e White British



e White British



P(number): Person with Dementia/number; SP(number): Study Partner/number

Summary of clinical data

Dementia Diagnosis

Sleep medication

Years since Dementia Diagnosis

RAID total score

CSDD total score

sMMSE score

P1 AD No 2 5 6 26P2 AD No 3 5 4 27P3 Unspecified No 3 12₸ 11* 18P4 AD No 3 11₸ 10* 21P5 AD No 7 8 11* 21P6 AD No 4 12₸ 9* 23P7 PCA No 1 7 8* 19P8 AD No 2 7 2 27P9 FTD, PPA Zopiclone,

PRN1 13₸ 13* 24

Mean (SD)

88.89 (2.96)

8.22 (3.39)

22.89 (3.18)

P#: Person with dementia #; AD: Alzheimer’s Disease; FTD: Frontotemporal dementia; PCA: Posterior Cortical Atrophy; PPA: Primary Progressive Aphasia; Unspecified: Unspecified dementia; PRN: Pro re Nata; RAID: Rating Anxiety in Dementia; CSDD: Cornell Scale for Depression in Dementia. ₸RAID score ≥11=significant anxiety; *CSDD score ≥8=significant low mood.

The PSQI, a highly specific (84%) and sensitive (99%) 19-item self-report

questionnaire, assessed degree of SDi (Buysse et al., 1989). The PSQI index

incorporates various aspects of sleep quality and has high sensitivity (89.6%), specificity

(86.5%) internal consistency (α=0.83) and test-retest reliability (r=0.85; Buysse et al.,

1989). A PSQI index of ≥5 at baseline implied significant SDi and justified inclusion

(Buysse et al., 1989). Mean baseline PSQI index was 9.78 (SD=3.19; Table 4).

Subjective sleep complaints varied and some PwD presented with multiple

complaints (n=6). PwD experienced: difficulties initiating (n=3) and maintaining (n=6)

sleep; excessive daytime sleepiness (n=5); waking during the night thinking it was

morning (n=1); and evening confusion (n=1). Mean duration of sleep problems was 2.77

years (SD=2.62). One person with dementia (P) took sleep medication (pro re nata) 1

night during the study, allowing them to get 3-4 hours continuous sleep. No other P

received treatment for SDi.

Poor affect frequently covaries with SDi (Livingston, Blizard & Mann, 1993). To

emulate an RCT, the Cornell Scale for Depression in Dementia (CSDD) and Rating

Anxiety in Dementia (RAID) were administered (Alexopoulos, Abrams, Young &

Shamoian, 1988; Shankar, Walker, Frost & Orrell, 1999). A CSDD score ≥8 indicated

significant low mood and a RAID score ≥11 is suggested significant anxiety (Harwood,

Ownby, Barker & Duara, 1998; Shankar, Walker, Frost & Orrell, 1999). Six participants

scored in the clinical range for depression and 4 for anxiety (see Table 3).

Table 4Summary of quantitative sleep outcome data

PSQI total score

(baseline)

Duration of sleep problems

(years)Nature of sleep disturbance

P1 9 1.5Difficulty initiating sleep; Difficulty maintaining sleep

P2 6 1 Excessive daytime sleepiness

P3 13 10Difficulty maintaining sleep; Excessive daytime sleepiness

P4 10 2Difficulty initiating sleep; difficulty maintaining sleep

P5 10 2Difficulty maintaining sleep, wakes in middle of night thinks its morning, excessive daytime sleepiness.

P6 14 1.5Difficulty maintaining sleep, excessive daytime sleepiness, evening confusion

P7 5 3 Excessive daytime sleepiness

P8 7 2.5 Difficulty maintaining sleep

P9 14 1.5Difficulty initiating sleep; Difficulty maintaining sleep; Evening confusion

Mean (SD) 9.78 (3.19) 2.77 (2.62)P#: Person with dementia #; PSQI: Pittsburgh Sleep Quality Index

Intervention

The intervention consisted of a gbMBI and GSH. Evidence suggests GSH is

ineffective as a stand-alone treatment but compliments other interventions (Schoicket et

al., 1988). Therefore, the gbMBI was considered the intervention’s “active” ingredient.

The guided brief MBI (gbMBI)

Permission to use a 13:48 minute Body Scan designed for sleep, recorded by

Rani Breslow (experienced meditation practitioner at University of California, Los

Angeles, USA) was granted (Appendix 4). Body scans are core mindfulness practices,

and was chosen because it assists the listener in focusing attention, by inviting them to

focus on something concrete (i.e. parts of the body). The Body Scan prompted listeners

to focus on the head, torso, arms, legs and toes, relaxing tension and observing

sensations. PwD were instructed to listen to the gbMBI at bedtime every night for 1

week and were invited to fall asleep during the gbMBI.

Good Sleep Hygiene guidance (GSH)

Acccording to NICE guidelines (2015), GSH was printed onto A4 paper, shared

and discussed with dyads (Appendix 6). Dyads were encouraged to implement

guidance not being followed immediately (implementation was not supported or

followed-up by the researcher). Adaptations were made to GSH to make it compatible

with the gbMBI: the device used to play the gbMBI was not discouraged and a quiet

bedroom was encouraged except for the sound of the gbMBI.

Procedure

Identified dyads were telephoned by the researcher (Table 5). During the initial

telephone call, dyads were briefed on the study and gave verbal consent to a short pre-

screening questionnaire (Appendix 3; Williams et al., 2010). If preliminarily eligible, the

study, gbMBI and commitments were briefly explained. If in agreement, Appointment 1

was arranged 1 week after the initial telephone call to allow dyads time to consider

participation prior to consenting. Detailed information sheets were posted to dyads

immediately following the initial phone call.

Appointment 1 took place at the participant’s home. Information sheets and

consent forms were reviewed and dyads received answers to questions, before signing

respective consent forms. Baseline quantitative measures were collected (PSQI,

sMMSE, RAID, CSDD; Appendix 3) through which eligibility was formally assessed,

providing validation for continuation with the study. Potential barriers to engaging with

the gbMBI were problem-solved with dyads. SPs were asked to complete a 1-week

sleep diary. Barriers to its completion were also problem-solved.

Table 5Summary of Study ProceduresPurpose of contact with dyads Contact schedule

Initial telephone callApprox. 25 mins.

Brief introduction to the study Pre-screening questionnaireBrief introduction to study commitments and gbMBIsBook Appointment 1Post information sheet

Appointment 1 (baseline)Face-to-faceDay 0Approx. 90 mins

Review of information sheet and question and answersConsent (P & Study partner)Baseline data collection (demographics, PSQI, MMSE, RAID, CSD)Eligibility assessmentProblem solving for engagement with gbMBISleep diary instructions (and problem solving)(Send GP letters)Book appointments 2 and 3

Appointment 2Face-to-face Day 7±1Approx. 50 mins

Sleep diary review and collectionGood Sleep Hygiene information shared and briefly discussedgbMBI introduction and practice. gbMBI instructions discussed and problem solved for engagement if neededSleep diary instructions (and problem solving)

Engagement with study intervention(1 week)

Implementation of GSH, as desired by dyadsNightly engagement with gbMBI by PwD, supported by study partnerDaily collection of sleep diary data by study partner

Appointment 3Face-to-face Day 14±2Approx. 70 mins.

Sleep diary feedbackPSQISemi-structured interviewDebrief/discharge

During Appointment 2, sleep diaries were collected and reviewed. GSH was

discussed, then the gbMBI was explained and practiced. The gbMBI was shared with

dyads in a format of their choice (i.e. CD; emailed and played using an iPad, mobile

phone or laptop). The researcher checked the gbMBI could be heard using chosen

devices. SPs were asked to complete another 1-week sleep diary.

During Appointment 3, sleep diaries were collected, PSQI administered and

semi-structured interviews conducted. Finally, dyads were debriefed and formally

discharged from the study.

Primary quantitative outcome data

Feasibility of RCT outcome data

This study aimed to emulate an RCT to practically test the study procedures.

This helped interpret whether eligibility, recruitment and attrition rates, and data

collection imply a successful RCT is feasible. Assessment of RCT feasibility was

interpreted by comparing quantitative factors from this study to that of successful RCTs

(Craig et al., 2008). Quantitive factors were: identification rate by source, dyad eligibility

rate (dyads eligible/dyads ineligible at pre-screen), dyad recruitment rate (dyads pre-

screened/dyads recruited); rate of recruitment by source; appointment non-attendance,

dyad attrition and gbMBI non-adherence rates due to practical reasons; and missing

data (Case Record Form and sleep diary).

Acceptability of gbMBI quantitative outcome data

The Theoretical Framework of Acceptability (TFoA) influenced gbMBI

acceptability assessment (Sekhon et al., 2017). Quantitative data contributing to

acceptability analysis were: appointment non-attendance, dyad attrition and intervention

non-adherence rates (sleep diary), all due to gbMBI dissatisfaction.

Secondary quantitative outcome data

Preliminary efficacy quantitative outcome data

There was an opportunity to assess gbMBI preliminary efficacy in this study.

Sleep outcomes would likely be the primary outcome measures in a larger-scale RCT.

Sleep parameters contributing to assessment of preliminary efficacy were chosen based

on previous research (LR, pg.51). They were pre- and post- intervention: PSQI index;

sleep onset latency (time taken to fall asleep); night-time sleep duration; number of

night-time awakenings and; subjective sleep quality rating. Excluding the PSQI, data

were collected via sleep diaries.

Sample size and quantitative data analysis

Due to its exploratory nature, no inferential analyses were planned, as

recommended for feasibility studies (Lancaster, Dodd & Williamson, 2004; Thabane et

al., 2010). Therefore, this study did not aim to achieve a priori power. Accordingly,

quantitative data were reported descriptively. Pre- and post-intervention mean

differences and standard deviations (SD) were reported from measures yielding

continuous data (e.g. PSQI index). Percentages and frequencies were reported from

measures yielding categorical data. Missing data was excluded from calculations of

mean differences and standard deviations. It was only possible to draw tentative,

preliminary conclusions from quantitative data.

Qualitative data

Qualitative data were gathered through field notes and interviews and explored

dyads’ perceptions of gbMBI acceptability and preliminary efficacy. Yardley’s (2000) 4

principles of good quality, credible qualitative research were followed (see Appendix 7).

Field notes were written by the researcher during and after each contact with dyads and

facilitated ongoing observation of dyads’ opinions. During Appointment 3, 40-60-minute

semi-structured interviews were conducted with both members of dyads simultaneously.

In developing the interview schedule (Appendix 8), the researcher consulted with 2

supervisors with expertise in older adult research and 1 in qualitative research methods.

Feedback from the University of Surrey (UoS) Service User Expert Committee was

implemented, ensuring language used was sensitive and accessible. Impromptu

probing questions were used by the researcher to expand discussions. The interview

schedule was reviewed after completing 2 interviews, at which time it became clear the

PwD required a reminder of the gbMBI. Accordingly, it was replayed at the beginning of

subsequent interviews. The researcher used discretion to ascertain whether PwD

remembered the gbMBI and played additional samples if needed.

Interviews were audio recorded, digitally transcribed in Microsoft Word 2010 and

anonymised. Six recordings were transcribed by the researcher (1 cross-checked by a

supervisor) and 3 recordings by a transcription service (all cross-checked by the

researcher).

Qualitative data analysis

There is ongoing debate around the number of participants needed to achieve

data saturation in qualitative research. Consistent with Guest, Bunce and Johnson

(2006) this study aimed to recruit up to 12 dyads. Data saturation was checked by the

researcher and a supervisor, and involved recoding each transcript according to

accumulated codes and themes, and cross-checking between transcripts and field

notes. No new relevant codes were generated by the 9th transcript, thus, data

saturation was inferred and the final sample size was 9 dyads.

Several methods of qualitative analysis were considered (e.g. interpretative

phenomenological analysis). However, Thematic Analysis (TA; Braun & Clark, 2006)

was chosen for 3 reasons: Interviews were conducted with both members of dyads

simultaneously as it was unclear how PwD would perform in an interview individually.

TA provides a flexible framework for interviewing, allowing data to be collected in this

way (Braun & Clark, 2006). TA facilitated compromise between pursuing answers to

pre-established research questions and the emergence of unexpected information,

allowing identification of common and less common perspectives, and intended and

unintended outcomes (O’Cathain et al., 2014). Lastly patterned, semantic meaning (not

latent meaning) was reported, thus, the idiographic focus of other qualitative methods

was not required.

Subthemes were developed iteratively, allowing their free emergence, consistent

with the exploratory nature of the study (Patton, 1990). To this end, once transcribed,

each interview was repeatedly read and coded by the researcher until familiar with

topics discussed. Codes were developed cumulatively, alongside collation of quotes

relevant to each code. Once each new transcript had been coded, quotes across

transcripts were re-grouped according to similarity (using Microsoft Excel 2010 and a

working thematic map; early thematic maps are presented in Appendices 9 and 10).

Codes were further explored and refined into subthemes, which were grouped into final

themes, deduced from established acceptability and efficacy frameworks. The

researcher cross-referenced field notes, adding context to narratives presented by

dyads in interviews.

Coding, theme development and thematic maps were cross-checked throughout

by a supervisor to ensure subthemes and quotes were not misinterpreted, taken out of

context or missed. Discrepancies were discussed and amended once a consensus was

reached between the researcher and supervisor.

Deduction of themes

Primary qualitative themes: Acceptability of gbMBI

To provide robust acceptability assessment, theme deduction was guided by

TFoA, which highlights 7 acceptability constructs (Table 6; Sekhon et al., 2017).

Perceived effectiveness was not considered, as this was more relevant to this study’s

secondary aim.

Secondary qualitative themes: Preliminary efficacy

Qualitative themes pertaining to improvements, non-changes or deteriorations in

SDi resulting from the gbMBI were drawn out of interviews, and contributed to

assessment of preliminary efficacy (Craig et al., 2008).

Table 6

Constructs included in the Theoretical Framework of Acceptability (Sekhon, Cartwright & Francis, 2017)Construct name Details of constructAffective Attitude How an individual feels about taking part in an intervention

BurdenThe perceived amount of effort that is required to participate in the intervention

Perceived Effectiveness1The extent to which the intervention is perceived as likely to achieve its purpose

EthicalityThe extent to which the intervention has good fit with an individual’s value system

Intervention CoherenceThe extent to which the participant understands the intervention and how it works

Opportunity CostsThe extent to which benefits, profits, or values must be given up to engage in an intervention

Self-efficacyThe participants confidence that they can perform the behaviours required to participate in the intervention

1Perceived efficacy was not considered in analysis of acceptability as this construct was more relevant to the study’s secondary aim

Mixed-method data triangulation

The researcher used a modified triangulation protocol to increase transparency

and replicability of the triangulation process (Erzberger & Prein, 1997; Farmer,

Robinson, Elliott & Eyles, 2006). The triangulation protocol was modified to only include

processes relevant to this study.

Triangulation was conducted over 2 phases: During “Sorting”, findings from

qualitative and quantitative data were grouped by research question, allowing datasets

to be observed together. “Convergence Coding” allowed datasets to be compared, and

the degree of agreement determined. This process allowed for conclusions around

gbMBI acceptability and preliminary efficacy, based on mixed-method data, to be

drawn.

Ethical considerations

This study was approved by the UoS Research Integrity and Governance Office,

National Research Ethics Committee (West Midlands-South Birmingham) and Trust 1,

Trust 2, Trust 3, Join Dementia Research and C4C research governance boards. This

study was conducted acording to all aforementioned governing bodies. Further ethical

considerations of this study are in Appendix 11.

Results

This study primarily aimed to assess: 1) feasibility of an RCT of a gbMBI for SDi

in PwD and; 2) gbMBI acceptability for PwD with SDi, and caregivers. Secondarily, it

aimed to assess gbMBI preliminary efficacy in alleviating SDi in PwD. Due to the

omission of inferential statistics, it was only possible to draw tentative, preliminary

conclusions from quantitative data. Quantitative data contributed to assessment of RCT

feasibility. Mixed-method data were used to determine gbMBI acceptability and

preliminary efficacy.

Follow up/Interview (n=9)

Analysis (n=9)

Received gbMBI (n=9)

Enrolled (n=9)

Assessed for eligibility (n=9)Enrolment

Ineligible (n=72) *Join Dementia Research (n=18)C4C (n=0)Trust 1 (n=43)Trust 2 (n=8)Trust 3 (n=3)Unknown (n=0)

Contacted by telephone (n=81)

Unable to contact (n=24)Join Dementia Research (n= 5)C4C (n=11) Trust 1 (n=2)Trust 2 (n=1)Trust 3 (n=4)Unknown (n=1)

Attempted contact by telephone (n=105)

Pre-screening

Figure 1 CONSORT flow diagram of the number of dyads at identification, pre-screening, enrolment, bMBI, follow-up and data analysis. All those enrolled received the bMBI; *See Appendix 12 for further demarcation.

Dyads identified (n=426)

Join Dementia Research (n= 25)C4C (n=379)Trust 1 (n=2)Trust 2 (n=11)Trust 3 (n=8)Unknown (n=1)

Identification

Primary quantitative outcome data: Feasibility of an RCT

Identification rate by source, dyad eligibility rate, dyad recruitment rate and

rate of recruitment by source

Overall 426 PwD were identified by various recruitment sources (Figure 1),

however due to time constraints, it was only possible to contact 24.6% of identified

PwD. Approximately 95% of all potential participants were identified by research

register. Overall, 105 potential participants were telephoned by the researcher. Of them,

81 dyads were successfully contacted and pre-assessed for eligibility. 89% (n=72) of

pre-screened dyads did not fulfil the inclusion criteria (see Appendix 12 for reasons),

meaning dyad eligibility rate was 11% (n=9). All 9 dyads who fulfilled the telephone pre-

screen were enrolled onto the study, thus, recruitment rate was also 11%.

22% (n=2) of dyads were recruited via Join Dementia Research and 44% (n=4)

were recruited via C4C, therefore dementia specific registers provided 67% of recruited

dyads. Clinician referrals were responsible for 33% (n=3) of recruited dyads (Trust 1:

0%; Trust 2: 22%; Trust 3: 11%). There were no self-referrals.

Appointment non-attendance, dyad attrition and gbMBI non-adherence

rates due to practical reasons

No dyads non-attended or dropped out of the study due to practical reasons.

Reportedly, the gbMBI audio failed on 1 night for P1 and P8, therefore, non-adherence

rate to the gbMBI for practical reasons was 3.17% (2/63 nights).

Missing data

Attempts were made by dyads to complete all sleep diaries. The rate of missing

data was 16.7% (week 1: 7/9 logs completed; week 2: 8/9 logs completed). All baseline

and follow-up outcome measures were fully completed.

Primary quantitative outcome data: Acceptability of gbMBI

Appointment non-attendance, dyad attrition and intervention non-

adherence rates due to gbMBI dissatisfaction

All dyads attended all study appointments. There were no drop-outs due to

gbMBI dissatisfaction. The non-adherence rate due to gbMBI dissatisfaction was 3.17%

(2/63 nights across dyads: P4 became upset by the gbMBI; P6 did not want to do the

gbMBI).

Secondary quantitative outcome data: Preliminary efficacy

Mean pre-post gbMBI difference in: PSQI index score; sleep onset latency;

night-time sleep duration; number of night-time awakenings and;

subjective sleep quality rating.

The mean pre-post-intervention PSQI index difference was -2.11 (SD=0.53)

(Table 7). Mean sleep onset latency reduced by 15.9 minutes (SD=3.95) and mean

subjective rating of sleep quality increased by 0.04 (SD=0.03). These findings signifying

a reduction in SDi. Contrarily, there was a 0.47 hour reduction in mean night-time sleep

duration (SD=0.15). Mean number of night-time awakenings increased by 0.22 post-

intervention (SD=0.16).

Table 7Summary of pre- and post-intervention quantitative data contributing to the assessment of preliminary efficacy

Mean PSQI total score Mean sleep onset latency (mins.)

Mean night-time sleep duration (hrs.)

Mean number of night-time awakenings

Mean subjective sleep quality rating (/5)₸

Week 1 Week 2 Week 1 Week 2 Week 1 Week 2 Week 1 Week 2 Week 1 Week 2P1 9 4 84.3 54 8.2 7.46 3.4 3.9 1.7 2.7P2 6 2 26.4 16 10.44 10.13 1.1 1.4 3.9 4.3P3 13 13 * 1.5 * 4.98 * 2.6 * 2.14P4 10 10 * * * * * * * *P5 10 10 56 27 6.9 7.56 2.6 2.5 2.4 2.7P6 14 6 44 26 7.83 7.23 0.5 0.3 3.3 3.4P7 5 5 13 5.7 8.72 8.28 1.1 1.14 4.4 4.2P8 7 4 15 21.4 8.28 7.8 0.29 1.7 3.5 3.4P9 14 15 210 234 2.05 2.73 5.1 4.3 2 1.7

Mean (SD) 9.78 (3.19)

7.67 (4.24)

64.1 (59.8)

48.2 (67.69)

7.49 (2.27)

7.02 (1.97)

2.01 (1.53) 2.23 (1.21) 3.03

(0.88) 3.07 (0.82)

Mean difference between means (SD)

-2.11 (0.53) 15.9 (3.95) -0.47 (0.15) 0.22 (0.16) 0.04 (0.03)

*Unable to calculate due to missing data; ₸0=poor sleep; 5=good quality sleep

Intervention coherence and

self-efficacy

Acceptability of gbMBI

SP prior knowledge of mindfulness and a lack of other provision prompted engagement

with the gbMBI

Intervention coherence and self-efficacy were impacted by cognitive impairment but

remedied by SP support and practice

The gbMBI was convenient, but difficult to incorporate

where there was no bedtime routine

Affective attitude and

ethicality

Aspects of the gbMBI were enjoyable, encouraging

engagement

Aspects of the gbMBI triggered negative feelings

A gbMBI is not for everyone

Burden and Opportunity

Cost

For most SPs, Burden and Opportunity Cost was

minimal, but for some, the gbMBI required effort and impacted on SP’s sleep

Preliminary efficacy of gbMBI

Figure 2Final thematic map

Perceived non-changes in SDi resulting from

the gbMBI

Perceived improvements in SDi resulting from the

gbMBI

Key

Study aim

Theme

Subtheme

Missing data

Dyad 4 did not complete both sleep diaries and Dyad 3 did not complete the

sleep diary for week 1, but did for week 2. Both Dyads did not complete the diary as

they were unable to establish a routine time to complete it. Additionally, Dyad 3 did not

complete the sleep diary because they were unable to do so accurately. However,

following problem-solving with the researcher during Appointment 2, Dyad 3 established

a routine and a strategy to increase accuracy of reporting (i.e. through a discussion

around the PwD’s sleep during breakfast).

Primary qualitative themes: Acceptability of gbMBI

To explore gbMBI acceptability, iteratively developed subthemes were grouped

into 3 deductive themes based on TFoA (Sekhon et al., 2017): intervention coherence

and self-efficacy; affective attitude and ethicality; burden and opportunity costs (Figure

2). Themes and subthemes are presented below alongside quotes from the interviews

and field notes that highlighted and unpacked them throughout the data corpus.

Intervention coherence and self-efficacy

SP prior knowledge of mindfulness and a lack of other provision prompted

engagement with the gbMBI

Prior positive experience of mindfulness (from hearing about it to having tried it)

was expressed by 4 SPs. Experiences appeared positive and were shared with the P,

which reportedly increased appeal of the gbMBI for the P. This reportedly created a

mutual willingness to engage with the gbMBI.

“…I know a bit about mindfulness anyway, so I thought it might be useful” (SP1).

Only 1 P had heard of mindfulness prior to the study. Generally, dyads

understood the gbMBI was designed to assist with SDi. However, there was uncertainty

around how the gbMBI worked at the beginning of the study for all PwD.

“…what were your expectations… about mindfulness?” (Researcher)

“…I thought there might be something that would improve my sleeping that’s all really.”

(P1)

“…did you…have an understanding or awareness of what you’d be doing?”

(Researcher)

“No…” (P1)

4 PwD communicated a sense that the gbMBI might impact their thoughts or

incorporate changes to their routine at the beginning of the study.

“…I suppose finding out what ways you could think about things differently. Somebody

might come up with “you’ve got to plan a proper day routine”, or something like that…”

(P8)

One dyad presented a view that the gbMBI was goverened by the “placebo

effect” after having engaged with the gbMBI.

“I think it’s a false technique...It may work for people and if it works it’s fine. You know, if

the placebo works, its fine. Use it... But it seems to me that I thought it was phoney...”

(SP3)

All dyads were motivated to participate and hopeful that the gbMBI would

alleviate SDi, suggesting their willingness to engage with available interventions. Two

PwD had been given GSH by services after reporting SDi (not implemented).

Otherwise, 1 had been referred for a sleep assessment, however, there was a year long

wait. Overall, dyads appeared motivated to receive the gbMBI because there was a lack

in other treatment provision, rather than because they understood or believed in the

benefits of the gbMBI.

“If anything could help, yes. And we went to UCL yesterday and their sleep thing – it’s a

year for me to do it, so I was trying anything else that would make a difference, to try

and get my sleep better.” (P9)

Intervention coherence and self-efficacy were impacted by cognitive

impairment but remedied by SP support and practice

Two PwD successfully initiated playing the gbMBI at the instructed time without

SP support from the outset. However, cognitive difficulties experienced by the P were

reported by 7 dyads as a barrier to performing behaviours required by the gbMBI. Two

dyads reported the P had difficulty absorbing instructions presented in the information

sheet, as it was too dense.

“…about the information sheet, it could be smaller… [P6] would maybe read through it

but none of it would be digested…” (SP6).

The current consensus is for SPs to be enlisted to support PwD engage with

interventions (Watson et al., 2014). Seven SPs supported the P to schedule

appointments with the researcher.

“…[SP7], it was you that was contacting me by email?” (Researcher)

“Yes, through saying to [P7], ‘What do you want me to say?’ (SP7).

Seven SPs provided support to play the gbMBI at bedtime.

“…. if you hadn’t had [SP7]’s help would you have been able to take part…?”

(Researcher)

“No, I wouldn’t have been able to.” (P7)

One P, who initially needed support to play the gbMBI, learned from the SP how

to play it independently.

“…you’ve got the remote control, so you can just press it.” (SP1)

“I can press it, yes” (P1)

All PwD understood they were required to follow the gbMBI but there were mixed

reports about whether the P could. Three PwD reported feeling able to engage with the

gbMBI content well from the outset:

“…we going to concentrate on now, is it your breathing…and everything she’s said to

me I’ve been able to immediately go to that position and tuck in.” (P6).

Five dyads reported that the P had difficulty following the gbMBI due to focusing

attention:

“...He understood what we were doing, but to actually get him to think about each part

like that, I think was a little bit too much.” (SP7)

concentration:

“My mind just drifted…. I’m not able to focus.” (P4)

and forgetting:

“The beginning, the first couple of lines, you forget…” (P4)

“… you forgot the purpose of it.” (SP4)

and 2 PwD reported that through practicing the gbMBI over several nights, it

became easier to engage with, as their increased experience led to predictability.

“…I listened to it properly and tried to expect what was happening next then…I got to

learn what’s happening didn’t I?” (P1)

The gbMBI was convenient, but difficult to incorporate where there was no

bedtime routine

Two PwD expressed their preference for this one-to-one intervention, as they

were not required to encounter other PwD to benefit from it. For example, 1 P presented

concerns about how they would manage interactions with other PwD in a group setting.

“I did wonder if I was going to be in a group and there was a lot of people that are worse

than me, that literally can’t get their words out and you sort of think, ‘Do you look at

them? What do you do?” (P8)

All dyads valued that appointments took place at home.

“…if I was living at home and it was somewhere else, I couldn’t guarantee that I could

get up, get dressed and be fed and off…” (P8).

Conducting the study appointments at dyads’ homes meant the researcher could

check the gbMBI was working on the chosen device. The gbMBI could be played on

several multimedia devices. Setting up the gbMBI within the allocated session time was

achieved with 8 of the dyads and was generally supported by the SP.

Three SPs highlighted that, where PwD had no bedtime routine, it was difficult to

synchronise gbMBI administration with their bedtime. Consequently, integrating the

gbMBI into PwD’s nightly activities was challenging.

“…most of the time, it’s trying to catch the moment when she’s ready to sleep and go to

bed … If there’s a pattern that emerges it’s difficult to know.” (SP4)

Affective Attitude and Ethicality

Aspects of the gbMBI were enjoyable, encouraging engagement

Several qualities, that made the gbMBI enjoyable and encouraged engagement,

were highlighted by 7 dyads (Table 8). Three PwD expressed a wish to continue with

the gbMBI post-study.

“…I said “do you want me to move it” and you said “no I’ll probably keep doing it”" (SP1)

“Yes, I’ll probably keep doing it.” (P1)

One P highlighted that they preferred that the gbMBI was an audio clip rather

than a script to read.

“I would rather have heard on a record than try and read it...” (P8).

Five PwD liked the voice of the speaker and one P went further to say that the

speaker’s voice was relaxing.

“…I liked her voice.” (P7)

“...her voice encourages you to keep going somehow.” (P8).

Four PwD said they liked the music.

“I did like the musical bits, because at times it was like whale music, and other times it

was like Indian music.” (P7).

One P liked that the clip featured a combination of speaking and music.

“...so, if it was just music and there was no speaking, what do you think? Do you think

that would be a good CD? (Researcher)

“No. It wants both. It needs somebody to tell you what you’re looking out for…” (P8).

Four PwD found the length of the gbMBI acceptable.

“Because it was shorter you have less to think of and more to remember…. You

remember what you’re hearing. And when you’re thinking of what you heard, you

haven’t got so much time where thinking is concerned, because you’re drowsy and

you’re dozing off” (P4).

Aspects of the gbMBI triggered negative feelings

Two dyads and 1 SP shared their opinion that the accent of the gbMBI speaker

irritated them.

“…when you first played it last week, [P3]’s immediate reaction was, ‘It’s an American

voice’, and I have to say I found it deeply irritating after a while” (SP3)

One P reported their awareness that they were forgetting what they had heard

during the gbMBI, which reminded them of their memory difficulties and upset them.

“You hear, you listen, you hear to remember. But I listen and I hear, to forget. Why?

There’s something wrong somewhere.” (P4)

A gbMBI is not for everyone

One dyad expressed the gbMBI was unsuitable because the P preferred being

physically active:

“…it’s not him to relax like that and listen to things. He just prefers to be active and

doing things. That’s how he’s been all his life…” (SP9)

One P expressed hostility resulting from the gbMBI treatment approach, as it was

at odds with their value system:

“…what [P3] is saying is that this whole technique that he has been exposed to is not

really genuine in terms of does it help people, but it is a gimmick. He didn’t use that

word and you did, I know, but it is what he’s saying, and he has a complete hostility to

people who operate like that.” (SP3)

Dyad 3 expressed their view that social processes and SDi are unlikely to be

alleviated by the gbMBI, rendering it disingenuous.

“[P3] is also making a class analysis of it, which is what he would always do…this kind

of technique is not about the realities of life of ordinary people and it doesn’t help the

lives of ordinary people because that’s not going to solve their problems. Their problems

are quite different to that in reality…this issue of sleeplessness is not going to be solved

by somebody making a career out of a tape and a programme and a whole theory,

which has got nothing to do with the real problems that cause people not to be able to

sleep, which could be poverty, it could be prejudice – you know, [P3]’s talking about

black and white, he’s talking about racial prejudice. That could be the problem. The

sleeplessness is not going to be a problem solved by meditation, which is part of

bourgeois culture. (SP3)”

Burden and opportunity cost

For most SPs, burden and opportunity cost was minimal, but for some, the

gbMBI required effort and impacted on SP’s sleep

To successfully administer the gbMBI, effort was required to facilitate

appointments and plan and execute the gbMBI, nightly. Proactive SPs were central to

delivery of the gbMBI for 7 dyads. Three SPs reported that supporting PwD to engage

with the gbMBI required little effort.

“It’s really no great hardship…” (SP2)

However, 2 SPs highlighted that since they needed to shut down their multimedia

device after the gbMBI played, it interfered with their sleep.

“…I had to shut my laptop down afterwards, and I would be asleep, you know, so it

might have been the mechanics of it that were a problem.” (SP3).

Secondary qualitative themes: Preliminary efficacy of the gbMBI

Themes highlighting dyads’ perspectives on perceived improvements, non-

changes or deteriorations in SDi following the gbMBI.

Four PwD commented that they felt the gbMBI helped them fall asleep quicker:

“I probably go to sleep more quickly...” (P2).

Two dyads and 1 P conveyed their perception that the gbMBI reduced the length

of time the P spent awake during the night.

“...sometimes he might get up in the night for an hour and can’t go back to

sleep but that hasn’t happened since we’ve been doing this…” (SP2)

Four dyads reported perceived improvements in the P’s overall sleep quality,

leading them to feel more refreshed in the morning.

“…I’m glad I did it as I can feel the quality of my sleep is better...And also you wake up

refreshed because I’m now getting a decent night’s sleep” (P6).

Three PwD reported no perceived changes in sleep as a result of engaging with

the gbMBI.

“…I’m constantly thinking about trying to get to sleep…but it doesn’t seem to help.” (P9)

No deteriorations in sleep were reported by dyads.

Mixed-method data triangulation

Quantitative and qualitative data were triangulated to establish overall gbMBI

acceptability and preliminary efficacy. Triangulation was informed by a modified protocol

and consisted of “Sorting” and “Convergence Coding” phases (Farmer et al., 2006).

During Sorting, mixed-method data were grouped according to the research questions,

allowing the datasets to be observed simultaneously (Table 9). During Convergence

Coding, degree of agreement between mixed-method data relating to gbMBI

acceptability and preliminary efficacy was determined.


Quantitative findings generally suggested the gbMBI was acceptable to PwD and

caregivers. Qualitative themes indicated several subtle factors that made the gbMBI

acceptable. However, contrary to quantitative findings, qualitative themes highlighted

important barriers to gbMBI acceptability. For example, the gbMBI was challenging to

integrate where there was no bedtime routine; gbMBI characteristics triggered negative

feelings and; a gbMBI is not for everyone. The datasets were coded as “partially

convergent”, as there were differences between them, but both suggested the gbMBI

was acceptable for most dyads.

Table 9Mixed-method data triangulation: sorted quantitative and qualitative data and associated convergence codesResearch Question Quantitative findings Qualitative theme Convergence code

Acceptability of gbMBI

Appointment non-attendance rate due to dissatisfaction with the gbMBI = 0%Dyad attrition rate due to dissatisfaction with the gbMBI= 0%Intervention non-adherence rate due to dissatisfaction with the gbMBI= 3.17%

Intervention coherence and self-efficacy: SP prior knowledge of mindfulness and a lack of other provision prompted engagement with the gbMBI; Intervention coherence and self-efficacy were impacted by cognitive impairment but remedied by SP support and practice; The gbMBI was convenient, but difficult to incorporate where there was no bedtime routine.Affective attitude and ethicality: Aspects of the gbMBI and its delivery triggered enjoyment and encouraged engagement; Aspects of the gbMBI triggered negative feelings; A gbMBI is not for everyone.Burden and Opportunity Cost: For most SPs, Burden and Opportunity Cost was minimal, but for some, the gbMBI required effort and impacted on SP’s sleep; Cognitive impairment required PwD to apply effort to engage with the gbMBI.

Preliminary efficacy of gbMBI

Mean pre-post gbMBI PSQI score difference= -2.11*Mean pre-post gbMBI sleep onset latency difference= -15.9 minutes*Mean pre-post gbMBI sleep quality rating difference (0.04).

Mean pre-post gbMBI sleep duration difference -0.47 minutes*Mean pre-post gbMBI number of night-time awakenings= 0.22**

The gbMBI had perceived positive effects on SDi

The gbMBI caused no perceived improvements in sleep

*a negative score signifies an improvement when pre-gbMBI score is compared with post-gbMBI score; ** a positive score signifies a deterioration when pre-gbMBI score is compared with post-gbMBI score; Informed by Farmer, Robinson, Elliott & Eyles, 2006


Both qualitative themes and quantitative data were yielded that suggested

preliminary improvements in SDi following the gbMBI. For example, both implied

improvements in sleep quality following the gbMBI. Conversely, both datasets

suggested the gbMBI was not experienced as wholly efficacious for all. For example,

quantitative data suggested there was a slight increase in number of night-time

awakenings following the gbMBI. Similarly, qualitative data highlighted no perceived

changes in SDi for 3 PwD. Overall, mixed-method data pertaining to gbMBI preliminary

efficacy were coded as “Convergent”.

Discussion

SDi is prevalent in PwD and impacts wellbeing and quality of life of PwD and

caregivers. Accessible, effective treatments for SDi in dementia are needed, but this

remains an under-researched area. Consequently, guidance and service provision is

lacking. Consistent with The National Dementia Strategy (DoH, 2009), this cohort study

primarily aimed to assess: 1) the feasibility of an RCT of a gbMBI for SDi in PwD and; 2)

gbMBI acceptability among PwD with SDi, and caregivers. Secondarily, it aimed to

assess gbMBI preliminary efficacy. Quantitative data were used to explore RCT

feasibility. Mixed-method data were used to explore gbMBI acceptability and preliminary

efficacy. A modified mixed-method data triangulation protocol unified mixed-method

data.

Summary of results and clinical implications

Is an RCT assessing the efficacy of a gbMBI on SDi in PwD feasible?

RCTs require vast resources. Thus, identifying issues that could interfere with

successful RCT conduct is economically and ethically beneficial (Craig et al., 2008).

Identification, recruitment and attrition challenges in studies recruiting PwD are well

documented and were predicted and experienced in this study (Watson et al., 2014).

This study used several strategies to counter these challenges (e.g. participants were

recruited from multiple sources). 66% of dyads were identified by registries, and 33% by

memory service clinican referral, supporting the usefulness of both recruitment

strategies (Watson et al., 2014). However, this finding was contrary to a study of a multi-

component NPI for SDi in dementia, in which 97% of PwD with SDi were recruited via

referral from memory clinics and 3% from a research register (Livingston et al., 2019).

The eligibility rate in this study (11%) was considerably lower than that of a study

recruiting similar participants (79%; Livingston et al., 2019). However, only 24.6% of

identified participants were screened for eligibility, and therefore the eligibility rate

presented may be inaccurate. Identifying eligible participants for the current study was a

considerable challenge, and suggests that an RCT may not feasible. However, 100% of

dyads identified as eligible during the telephone pre-screen were recruited, validating

this strategy (Williams et al., 2010). This rate exceeded that of a similar study in which

only 66% of eligible PwD with SDi were recruited (Livingston et al., 2019). No

participants were recruited following self-referral. Reasons for this were beyond the

scope of the study. No dyads non-attended appointments or dropped-out, therefore

attrition rate surpassed the rate considered acceptable for successful RCTs in PwD

(20%; Birks & Harvey, 2006). Study appointments took place in P’s homes, which may

have reduced recruitment and attrition challenges (Jones, Andrieu, Knox & Mackell,

2010). Unlike a potential RCT, this study was brief and all participants received the

intervention. Greater recruitment and attrition challenges may be expected in a

longitudinal, placebo-controlled RCT.

This study’s procedures emulated an RCT and aimed to identify procedural

issues that could interfere with RCT conduct. Findings showed rate of gbMBI adherence

(93.66% overall) exceeded that of successful RCTs for PwD (10.7%-38%, Smith et al.,

2017). This suggests the level of engagement required from dyads in this study would

be feasible in an RCT (Enders, 2003). However, due to this study’s design, it was

unclear whether an RCT control group would be equally as engaged. Sleep diary

completion (83.3%) was comparable to, and questionnaire completion (100%)

exceeded that of a study recruiting similar participants (Livingston et al., 2019).


Treatment acceptability is correlated with improved clinical outcomes and

treatment satisfaction (Jahng, Martin, Golin & DiMatteo, 2005; Lee & Lin, 2010; Loh et

al., 2007). Quantitative data showed gbMBI non-adherence, dyad attrition and

appointment non-attendance rates due to gbMBI dissatisfaction were low, suggesting

the gbMBI was generally acceptable (Blenkinsopp & Hassey, 2005; Kulier, Helmerhorst,

Maitra & Gülmezoglu, 2004).

Qualitative themes were largely supportive of acceptability but provided nuanced

findings about factors that influenced acceptability in both directions. Findings showed

several dyads were initially motivated to engage due to a lack in other treatment

provision.The mechanisms of MBIs are poorly understood. Speculatively, MBIs create

change by stimulating self-examination, awareness and compassion, prompting

changes in affect regulation, stress impulse reactions and behaviour (Bishop et al.,

2004). Consistent with speculations, the expectations of 4 PwD were in line with

expectations of the gbMBI, suggesting acceptability.

Dementia impairs cognition, which had the potential to impact on the P’s ability to

perform the behaviours required by the gbMBI (e.g. remember to play the gbMBI at the

appropriate time; Johnco et al., 2013). Several dyads highlighted difficulties for the P in

following the gbMBI. Difficulties focusing attention and sustaining attention during MBIs

are present among adults without cognitive impairment (Kane et al., 2007). It was

unclear to what extent these difficulties may be elevated in PwD due to cognitive

impairment. Evidence shows that PwD are capable of implicit learning (Fleischman,

2007).

These findings did not indicate that a gbMBI would be preferred given a choice of

interventions. Data suggested some SPs held positive perceptions of MBIs, suggesting

prior knowledge of similar treatments increased acceptability and willingness to engage,

in dyads (Williams & Kabat-Zinn, 2013). Some gbMBI characteristics (e.g. music) were

reportedly enjoyable, whereas others were not. For example, the gbMBI clip had an

American speaker. This study was conducted in South England and there is evidence to

suggest that British people have an aversion to American accents (Hiraga, 2005).

These findings suggested there was room for improvement with regards to the gbMBI

content. Cognitive impairment in PwD may have impacted engagement with the gbMBI

content, although evidence suggests engaging with MBIs can be challenging for adults

without cognitive impairment (Kane et al., 2007). Notably, findings from this study

showed forgetting the gbMBI content could trigger distress in the P, countering

acceptability. Consistent with other studies, some PwD expressed that increased gbMBI

practice made it more predictable, suggesting acceptability may increase over time

(Winbush et al., 2007). However, this study was short, therefore predicting long-term

acceptability was impossible.

For many, receiving a dementia diagnosis triggers emotional difficulty and

necessitates a period of adjustment. Many interventions for PwD are delivered in a

group setting following diagnosis, meaning people with milder dementia may need to

encounter other PwD despite feeling emotionally challenged (Cheston & Ivanecka,

2017). The individual delivery of the gbMBI was highligted as a factor that improved

acceptability. Findings highlighted practical engagement (e.g. booking appointments)

was not possible for several PwD and support from SPs was instrumental, consistent

with previous research (Watson et al., 2014). Findings did not suggest that SP support

was unacceptable to PwD, however, qualitative analysis was restricted to semantic

meanings. Varying levels of support and effort required by SPs may correlate with

cognitive impairment in PwD (Hellström, Nolan & Lundh, 2007). The efforts and burdens

of caregivers of PwD are well documented. Therefore, interventions that produce

minimum burden and opportunity cost are desirable (Kim, Oh & Richards, 2014; Black

et al., 2018). Although some SPs reported the required support was undemanding,

some highlighted impracticalities (e.g. delivery via laptop impacted the SP's sleep, as

they stayed awake in order to shut-down the laptop).

Consistent with the current consensus, GSH, which encourages bedtime routine,

was shared with dyads as part of this study. However, compliance was neither

obligatory nor measured, which likely impacted its uptake (Taylor & Pruiksma, 2014).

Some SPs reported that the gbMBI was challenging to integrate where there was no

bedtime routine, perhaps making a case for greater emphasis on GSH to increase

acceptability (Schoicket et al., 1988).

Conversely, literature postulates that the mechanisms of MBIs are governed by

the “placebo effect” rather than the MBI itself (Van Dam et al., 2018). For example,

having a face-to-face conversation with a professional or the expectation that difficulties

will be alleviated as a result of engaging with an intervention, are factors common

across most treatments. In support, research suggests that where an MBI was trialled

against an active intervention, smaller treatment effect sizes were yielded (Shonin, Van

Gordon & Griffiths, 2014). This sudy and previous research suggests this intervention

may not be appropriate for all- particularly for those who hold this perspective.

The gbMBI conflicted with the value system of 2 dyads, also implying a gbMBI is

not acceptable for everyone. For example, one dyad highlighted the importance of

considering social processes (e.g. experiencing discrimination) alongside SDi and

managing them accordingly. Moreover, the evidence base suggests that the links

between sleep and social processes are bidirectional (i.e. sleep quality impacts

interactions with the world and vice versa; Gordon, Mendes & Prather, 2017). Further,

findings from this study suggested few PwD were offered timely, effective treatment for

SDi (e.g. research shows GSH is ineffective in prompting clinical change as a stand-

alone treatment; Schoicket et al., 1988). Therefore, this study supports the development

of a range of effective NPIs, enabling people to select an intervention based on their

own beliefs and preferences (Buchan & Dal Poz, 2002).


Preliminary efficacy findings were presented tentatively as no inferential analyses

were conducted. Additionally, this study was likely too short to detect efficacy (Chan et

al., 2016).

Lack of research into gbMBIs for SDi in dementia makes comparing between the

wider evidence and the findings of this study challenging. Consistent with research in

adults, 6 dyads reported perceived improvements in sleep onset latency, night-time

wakefulness and sleep quality (Klatt, Buckworth & Malarkey, 2009; Gellatly et al., 2007;

Khoury et al., 2013). Improvements in SDi found in this study were consistent with a

study of a MBT for SDi in PwD, in that some aspects of SDi improved whereas others

did not (Chan et al., 2016). However, no perceived changes were reported by 3 dyads.

This may have been because the gbMBI was ineffective. Arguably, insufficient time was

allowed for observable improvements to be felt (Chan et al., 2016).

No dyads reported deteriorations in SDi following the gbMBI, however, findings

from this study suggest adverse responses to the gbMBI may be possible among PwD

(Van Gordon, Shonin & Garcia-Campayo, 2017).

Overall, preliminary efficacy findings from this study were inconclusive. However,

given the prevalence and impairment caused by SDi in dementia, and lack in other

provision, preservation or modest improvements may be important at the population

level (Solomon et al. 2014). Further, there may be a delay in benefits, as practice and

familiarity with the gbMBI develops (Chan et al., 2016).

Further research

This cohort study aimed to emulate an RCT, providing a methodological blueprint

on which future studies can build. The efficacy of a gbMBI in treating SDi in dementia

should be assessed through an appropriately powered RCT. Future researchers would

benefit from implementing appropriate controls for depression and anxiety

presentations, as they co-vary with SDi in PwD (Livingston, Blizard & Mann, 1993).

Expected recruitment challenges should be taken into account and strategies to

increase dyad identification adopted (e.g. recruitment from several sources; Watson et

al., 2014; Treweek et al., 2010). The telephone pre-screen provided a resourceful

strategy for an RCT to adopt to highlight eligible dyads. An RCT should allow a

prolonged intervention period, as previous research suggests it takes 2-6 months for

mind-body treatments to produce observable effects in PwD (Chan et al., 2016).

Providing GSH as a control condition and comparing this with a gbMBI plus GSH

condition may help ascertain how much of the intervention is attributable to GSH. GSH

should be provided to participants first and active encouragement for dyads to

implement guidance may mean that those who struggle to engage with the gbMBI

because they do not have a bedtime routine are enabled to do so.

The researcher also made efforts to encourage identification of eligible

participants (e.g. through linking with 1 clinician in memory services). Just 24.6% of

identified participants were screened for eligibility (which may have skewed findings),

however, overall eligibility rate in this study was low. Inclusion and exclusion criteria

were designed to improve internal validity of the study. However, in reality, the criteria

may be too stringent, and one way to increase eligibility rate would be to simplify

recruitment enrolment criteria (e.g. including people with physical health problems likely

to impact on sleep). Additionally, the telephone pre-screening questionnaire may be too

stringent and future researchers may wish to develop it further.

With regards to the gbMBI, delivery in an audio format appeared to be

acceptable. However, it would be beneficial to consider alternative delivery methods or

devices that would not disturb SPs. The gbMBI itself could be similar in length, and

feature music and words. Due consideration should be given to the accent of the gbMBI

speaker and to providing more frequent repetition of instructions during the meditation

exercise in order to overcome difficulties with forgetting content.

SP involvement appeared pivotal to successful gbMBI delivery and this appeared

to be acceptable. However, further research may investigate whether an accessible

version of the gbMBI instructions empowers the P to engage with it independently

(reducing the burden on SPs).

In terms of outcomes, seeking quantitative and qualitative feedback at

acceptable, regular intervals would help ascertain at what point the effects of the gbMBI

are felt. Actiwatches provide an automated method of collecting vast amounts of sleep

data which lightens the burden on SPs and may identify disturbances not detected by

SPs (Gibson & Gander, 2018). Therefore, Actiwatches may encourage prolonged

engagement with an RCT and provide good quality data. The use of additional

measures (e.g. quality of life, depression and anxiety) may strengthen findings.

Longitudinal follow up exceeding 6 months would help ascertain long-term effects of the

gbMBI. These outcomes could contribute to key decision making by clinicians when

considering gbMBIs in practice. Further, this information would enable clinicians to

manage patients’ expectations.

Strengths and limitations

This study aimed to contribute to knowledge and development of a pragmatic

(i.e. resource-light, deliverable) treatment for SDi in dementia. The gbMBI was delivered

by the researcher (a Trainee Clinical Psychologist) with no specific MBI practitioner

training during 1 intervention session. Therefore, to some extent this aim was achieved.

However, the researcher had a good understanding of the background literature and

was trained in other therapeutic skills (e.g. active listening, problem solving). Therefore,

the researcher may have drawn upon doctoral level knowledge and skills acquired as a

Trainee Clinical Psychologist to encourage engagement. Ideally, this intervention would

be delivered by a graduate psychologist, supervised by a Clinical Psychologist, in

practice (Livingston et al., 2019). However, this study was unable to inform on whether

the intervention was deliverable in this way. It was unclear what training and experience

a graduate psychologist would need.

Most SPs in this study were spouses, however, research suggests that

increasingly, PwD live alone (Alzheimer's Association, 2013). Successful gbMBI

administration relied on SPs for many, therefore this is a weakness of the gbMBI. This

study aimed to alleviate SDi assuming this would enable PwD to live well (DoH, 2009).

However, it did not use a quality of life measure to corroborate this, nor did it examine

other measures of psychological wellbeing such as depression or anxiety.

This study was novel and provided a wealth of interesting, useful, previously

unavailable information on gbMBIs for SDi in dementia. However, it was unclear how

much of the intervention could be attributed to GSH, due to the study design (Van Dam

et al., 2018). Moreover, this study was short, omitted empirical analyses and all

participants received the intervention. Therefore, it may not have accurately represented

the challenges of an RCT (e.g. there was no randomisation and thus no randomisation

fear; Jenkins & Fallowfield, 2000). Despite suggesting an RCT may be feasible in terms

of retention and adherence, eligiblity rate was low, countering feasibility.

Dyads were aware the current study was being conducted as part of a doctoral

qualification. Also, this study used self-report outcome measures and face-to-face,

audio recorded interviews with the researcher. Participants could have felt

uncomfortable disclosing unfavourable views or pressure to provide positive responses

(Jenkins & Fallowfield, 2000). However, a mix of both positive and negative perceptions

of the gbMBI emerged from data, suggesting it was not biased in an overly favourable

way.

Collecting quantitative and qualitative data with dyads was challenging. A change

in the interview schedule was introduced as PwD appeared unable to remember the

gbMBI. Despite this, it remained unclear how much of the gbMBI PwD remembered

during interviews, which may have invalidated responses. Some PwD had expressive

language difficulties and SPs clarified their perspectives. However, it was unclear

whether PwD were being accurately represented by SPs, which may have biased data.

Conclusion

SDi is a common symptom of dementia, implicating wellbeing and quality of life.

There is no clear guidance or readily available provision to alleviate SDi in dementia.

gbMBIs present a pragmatic, potentially affective treatment for SDi in dementia. This

study aimed to contribute to this under-researched area by assessing: the feasibility of

an RCT investigating a gbMBI for SDi in dementia; and the acceptability and preliminary

efficacy of a gbMBI in alleviating SDi in dementia.

Results showed a gbMBI can be delivered by a trainee clinical psychologist with

no specific mindfulness practitioner training in 1 session with the support of a caregiver.

However, it was unclear whether the intervention could be delivered by a graduate

psychologist. Quantitative data showed that an RCT may be feasible in terms of

retention and adherence, but not eligibility. This study did not adopt an RCT design and

was shorter than would be required, reducing its generalisability. Recommendations for

further research were provided, which may increase RCT feasibility. Triangulated

mixed-method data suggested the gbMBI was acceptable for several PwD, but not for

all (e.g. people requiring social interventions). An alternative voice on the gbMBI and

greater emphasis on GSH may increase acceptability. This study was underpowered

and too short to detect change, however preliminary efficacy findings appeared

contradictory and therefore, inconclusive. However, considering the impact of SDi in

dementia, preservation or modest improvements in SDi may be important at the

population level, and therefore a gbMBI may be valuable in the context of a range of

potential treatments selected according to PwD’s needs (Deschenes & McCurry, 2009).

It is possible that several studies may be needed to develop and assess the efficacy of

a gbMBI among PwD with SDi. However, in the absence of other treatments, further

research is necessary. This study supports further research into gbMBIs for SDi in

dementia.

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List of Appendices

Appendix 1: Epistemological position and reflexivity

Appendix 2: Study leaflet

Appendix 3: Study case record form

Appendix 4: gbMBI (Body Scan for sleep) transcript (13:50 mins)

Appendix 5: Telephone pre-screening questionnaire script

Appendix 6: GSH leaflet provided to dyads

Appendix 7: Principles of quality qualitative research (Yardley, 2000)

Appendix 8: Interview Schedule

Appendix 9: Earlier thematic map for acceptability of gbMBI

Appendix 10: Early thematic map for perceived efficacy of the gbMBI

Appendix 11: Further ethical considerations

Appendix 12: A table showing the reasons for dyad ineligibility by recruitment source

Appendices

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Appendix 1: Epistemological position and reflexivity

Epistemological position

In the interest of transparency and to aid assessment of the conduct and

outcomes of empirical research, particularly qualitative research, it is good practice for

researchers to disclose their, epistemological position, assumptions and background.

Disclosure enables the reader to consider alternative interpretations of the findings,

accordingly (Elliott, Fischer, & Rennie, 1999; Smith, 1990).

The current research utilised mixed-method (i.e. quantitative and qualitative)

methods to address the research question. Quantitative and qualitative methods are

commonly thought to be distinct, contradictory epistemological positions, meaning that

much research sticks to 1 paradigm or the other (Todd, Nerlick, McKeown & Clarke,

2004; Pope & Mays, 1995). Quantitative research is driven by positivist ideology, which

values the operationalisation of concepts, hypothesis testing, objectivity, replicability,

generalizability, validity and reliability. Qualitative research, on the other hand, aims to

generate explanations through understanding subjective experiences and the

construction of reality, in this case, from the perspective of the dyads and the

researcher (Todd, Nerlick, McKeown & Clarke, 2004; Billig, 1994). The current study

does not perceive quantitative and qualitative methods as mutually exclusive, but rather,

complementary and therefore a pluralist, mixed-method approach was adopted

(Casebeer& Verhoef, 1997; Yardley, 1999).

Thematic analysis, the qualitative method of analysis, does not require fixed

subscription to a specific epistemological position, making it a flexible method (Braun &

Clarke, 2006). However, with regards to the analysis of the qualitative data, this study

holds an essentialist epistemological position which aims to retain the complex richness

of the qualitative data in the context of the specific research questions. Thus, the

analysis is largely deductive, aiming to explore the feasibility of an randomised

controlled trial and acceptability and preliminary efficacy of the gbMBI for dyads. The

study reported the assumed reality and experiences evident in the qualitative data and

aimed to provide a descriptive overview of the key semantic features of the data to

answer the research questions.

The positions and assumptions of the researcher were developed over time in

collaboration with the researcher’s supervisors and documented in the supervision

notes. At the time of analysis, these positions and assumptions were viewed as the best

way to assess whether an RCT into the gbMBI is plausible, whether dyads perceived

the gbMBI as an acceptable, viable intervention option and their perceptions of the

efficacy of the gbMBI.

Reflexivity

At the time of completing this thesis, the researcher was a 30-year-old woman of

Black British heritage and this study contributed to a doctoral qualification in Clinical

Psychology. The study was developed in collaboration with four research supervisors-

two of whom had a background in research with older people and two who had

significant experience in conducting and supervising qualitative research projects. One

of the research supervisors had a specific interest in the applications of gbMBIs for

older people and this study was initially developed in collaboration with them. The

researcher had a background in quantitative research with older PwD, conducted an

MSc thesis on sleep problems in older PwD and a personal interest in Mindfulness

interventions, making this an attractive, suitable and interesting research project to

pursue.

Supervisors’ support in the conduct of this research afforded the researcher

plenty of opportunities to reflect on experiences, central to the illumination of their

assumptions and attitudes and how they might have impacted the study. Through

reflective conversations, the researcher could consider their position and was more

conscious of how this could influence the development of the study, thesis and the

researcher. As such, the researcher was better positioned to make decisions about how

best to proceed with the study. For example, initially, the researcher aimed to conduct a

pilot cohort study, using quantitative data to assess the feasibility and preliminary

efficacy of the gbMBI, and the qualitative interview to assess the acceptability of the

MBI across the dyads. As such, the identification of themes using content analysis

would identify the themes of importance and would be used to support the quantitative

data. The researchers’ approach to the research questions was largely quantitative,

valuing the use of numbers and statistical methods to reliably and validly assess the

answers. Considerable delays in obtaining REC and R&D approvals meant that meeting

a priori power would be unfeasible. Therefore, a decision was jointly made between the

researcher and supervisors to change tact and adopt a contingency study (i.e. this

study) as the main study. Although initially daunting, this change in tact afforded the

researcher the opportunity to explore the richness of a qualitative approach. Through

conducting and analysing the interviews, the researcher reached saturation, thereby

providing replicability at some level. The researcher was also able to gain vast, wholly

valid (albeit individual) insights into the experiences of the dyads with regards to the

gbMBI, and beyond. As such, the researcher was provided broader, deeper information

that would have existed, but likely would not have been explored had the researcher

stuck to a more quantitative approach. Inevitably, this has led the researcher to ponder

whether a quantitative approach, particularly at this exploratory stage, might have

hindered the potential to learn from the dyads.

References

Billig, M. (1994). Repopulating the depopulated pages of social psychology. Theory &

Psychology, 4(3), 307-335.

Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative

research in psychology, 3(2), 77-101.

Casebeer, A. L., & Verhoef, M. J. (1997). Combining qualitative and quantitative

research methods: Considering the possibilities for enhancing the study of

chronic diseases. Chronic diseases in Canada, 18(3), 130-135.

Elliott, R., Fischer, C. T., & Rennie, D. L. (1999). Evolving guidelines for publication of

qualitative research studies in psychology and related fields. British journal of

clinical psychology, 38(3), 215-229.

Pope, C., & Mays, N. (1995). Qualitative research: reaching the parts other methods

cannot reach: an introduction to qualitative methods in health and health services

research. British medical journal, 311(6996), 42-45.

Smith, J. K. (1990). Alternative research paradigms and the problem of criteria. The

paradigm dialog, 167-187. London:Sage

Todd, Z., Nerlich, B., McKeown, S., & Clarke, D. (Eds.). (2004). Mixing methods in

psychology: The integration of qualitative and quantitative methods in theory and

practice. Hove: Psychology Press.

Yardley, L. (1999). Understanding embodied experience. Qualitative Health Psychology

Theories and Methods, 31-46.

Appendix 2: Study leaflet/poster

Page 1 Page 2

Appendix 3: Study case record form

CASE REPORT FORMA prospective cohort study examining

the feasibility, acceptability and preliminary efficacy of a brief

mindfulness-based intervention for sleep disturbance in older adults with

dementia.

Mindfulness for sleep disturbance in older adults with dementia.

Chief Investigator: Melody Smith (Trainee Clinical Psychologist)Lead Supervisor: Dr. Paul E. DavisField Supervisor: Dr. Rebecca GouldTrust: CRF Version Number: v0.4, 11/07/2016Patient initials: Participant No:Screening No: Centre No:

CRF Completion InstructionsGeneralComplete the CRF using a black/blue ballpoint pen and ensure that all entries are complete and legible.

Avoid the use of abbreviations and acronyms.

The CRF should be completed as soon as possible after the scheduled visit.

Do not use subject identifiers anywhere on the CRF, such as name, hospital number etc., in order to maintain the confidentiality of the participants. Ensure that the header information (i.e. subject’s initials and ID number) is completed consistently throughout the CRF. Missing initials should be recorded with a dash (i.e. D-L).

Ensure that all fields are completed on each page:

● If a test was Not Done record ND in the relevant box(es)

● Where information is Not Known write NK in relevant box(es)

● Where information is not applicable write NA in the relevant box(es)

Corrections to entriesIf an error is made, draw a single line through the item, then write the correct entry on an appropriate blank space near the original data point on the CRF and initial and date the change.

Do NOT● Obscure the original entry by scribbling it out

● Try to correct/ modify the original entry

● Use Tippex or correction fluid

Verbatim Adverse Event terms (initial medical term) should be recorded as the final diagnosis whenever possible.

Complete all dates as day, month, year i.e. 13/NOV/2008. Partial dates should be recorded as NK/NOV/2008.

All times are to be recorded in 24 hour format without punctuation and always use 4-digits; i.e. 0200 or 2130. Midnight is recorded as 0000.

Weights should be recorded to the nearest 0.1 kg.

If a subject prematurely withdraws from the study a single line must be drawn across each uncompleted page to correspond with the last visit of the subject as mentioned on the “Study Completion” page.

StorageCRF documents should be stored in a locked, secure area when not in use where confidentiality can be maintained. Ensure that they are stored separately to any other documents that might reveal the identity of the subject.

Telephone Call (PRE-SCREENING) CHECKLISTBased on ICD-10 G47 (Sleep disorders) Yes No

1.

Has there been any changes to your sleep pattern since you started to have memory problems? (A change from the patient's baseline sleeping pattern, either an increase or a decrease in the number of hours slept. This can also refer to alterations in the stages of sleep.)

☐ ☐

2. Do you wake up feeling tired or feel very sleepy during the day, even if you have had enough sleep? ☐ ☐

3. Is it hard for you to fall asleep or stay asleep through the night? ☐ ☐

4. Do you ever feel more confused in the evening time? ☐ ☐

5. Have you ever woken up, as though the morning to find that it was still the middle of the night? ☐ ☐

Must answer “yes” to at least one of the above questions

6. Have you ever been diagnosed with sleep apnea (problems with breathing that cause loud snoring). ☐ ☐

7. Do you have heart disease, lung disease, or a nerve disorders. ☐ ☐

Must answer “no” to the above questions

Appointment 1 (SCREENING) CHECKLIST

Date of Appointment: __ __ / __ __ __ / __ __ __ __ (DD / MMM / YYYY)

Appointment Checklist: Yes No

1. Demographic Data ☐ ☐

2. Clinical Information ☐ ☐

3. PSQI ☐ ☐

3. MMSE ☐ ☐

4. CSD ☐ ☐

5. RAID ☐ ☐

6. Medication ☐ ☐

7. Smoking/alcohol status ☐ ☐

8. Inc/Exc criteria ☐ ☐

9. Sleep diary ☐ ☐

10. Intervention date ☐ ☐

11. Follow up date ☐ ☐

Informed Consent:

Date participant signed written consent form:

__ __ / __ __ __ / __ __ __ __ (DD / MMM / YYYY)

Date study partner signed written consent form:

__ __ / __ __ __ / __ __ __ __ (DD / MMM / YYYY)

Name of person taking informed consent: ____________________________________________

Appointment 1 (SCREENING) DEMOGRAPHIC DATA (STUDY PARTNER)

Demographic Data:

Date of Birth: __ __ / __ __ __ / __ __ __ __ (DD / MMM / YYYY)

Ethnicity:White White British ☐ White Irish ☐ White Other ☐

Mixed race White & Black Caribbean

☐ White & Black African

☐ White & Asian ☐ Other mixed background

☐Asian or Asian British

Indian ☐ Bangladeshi ☐ Pakistani ☐ Other Asian background

☐Black or Black British

Caribbean ☐ African ☐ Black Other ☐Chinese or other ethnicity

Chinese ☐ Other ☐ (please specify)

Sex: ☐ Male

☐ Female

Relationship to participant:

Son/Daughter Friend ☐ Spouse/Cohabitee ☐ Other ☐ ___________

How often do you see the participant?Continuously ☐ Daily ☐ 4-6 days a week ☐ Other ☐ ___________

How long have you known the participant? ___________years

Appointment 1 (SCREENING) DEMOGRAPHIC DATA (PARTICIPANT)

Demographic Data:

Date of Birth: __ __ / __ __ __ / __ __ __ __ (DD / MMM / YYYY)

Ethinicity:White White British ☐ White Irish ☐ White Other ☐

Mixed race White & Black Caribbean

☐ White & Black African

☐ White & Asian ☐ Other mixed background

☐Asian or Asian British

Indian ☐ Bangladeshi ☐ Pakistani ☐ Other Asian background

☐Black or Black British

Caribbean ☐ African ☐ Black Other ☐Chinese or other ethnicity

Chinese ☐ Other ☐ (please specify)

Sex: ☐ Male

☐ Female

Marital status:

Married ☐ Widowed ☐

Separated ☐ Divorved ☐

Single ☐

Number of years in education:

Highest level of educational achievement:

Highest level of occupational attainment:

Appointment 1 (SCREENING) CLINICAL INFORMATIONHistory of memory difficulties:

Date of diagnosis: __ __ / __ __ __ / __ __ __ __ (DD / MMM / YYYY) Or __________ years

Diagnosis from whom: Memory Service ☐ Other (specify) ____________________________

First symptoms:

Year of onset: __ __ / __ __ __ / __ __ __ __ (DD / MMM / YYYY) Or __________ years

Age at onset:

Pattern of memory difficulties: Gradual Fluctuating Stepwise

Current treatment for memory difficulties:

Yes☐

No☐

History of any other neurodegenerative disease (e.g. Parkinson’s disease)

☐ ☐

History of epilepsy: ☐ ☐

History of neurological difficulties: ☐ ☐

History of mental health difficulties: Yes

☐details below

No☐

Date from-to Treatment

Curent suicidal ideation

Current suicidal intent

Yes☐

☐

No☐

☐

History of sleep disturbance:

Irritability, aggression confusion at particular times of day?

Date of onset of sleep disturbance:

__ __ / __ __ __ / __ __ __ __ (DD / MMM / YYYY) Or __________ years

Treatments for sleep disturbance:

Intellectual difficulties? Yes☐

No☐

History of stroke? ☐ ☐Difficulties hearing? ☐ ☐

Appointment 1 (SCREENING) PITTSBURGH SLEEP QUALITY INDEX

Appointment 1 (SCREENING) STANDARDISED MINI MENTAL STATE EXAMINATION

Appointment 1 (SCREENING) CORNELL SCALE FOR DEPRESSION IN DEMENTIA

--------------------------------------------------------------------------------------------------------------------------

--------------------------------------------------------------------------------------------------------------------------

Appointment 1 (SCREENING) RATING ANXIETY IN DEMENTIA

Appointment 1 (SCREENING) MEDICATIONS

Date of Assessment: __ __ / __ __ __ / __ __ __ __

(DD / MMM / YYYY)

Is the participant taken any concomitant medications at screening. ☐ No ☐ Yes, Complete below

Medication(Record Generic or

trade name)

Reason for use (Medical History

diagnosis or other reason, e.g. Prophylaxis)

Dose and units

Freque-ncy

Route Start Date (DD/MMM/YYYY)

Stop Date (DD//MMM/YYY)

Or tick if

ongoing at

Screening

Appointment

1.____/_____/_____ ____/_____/_____

☐

2.____/_____/_____ ____/_____/_____

☐

3.____/_____/_____ ____/_____/_____

☐

4.____/_____/_____ ____/_____/_____

☐

5.____/_____/_____ ____/_____/_____

☐

6.____/_____/_____ ____/_____/_____

☐

7.____/_____/_____ ____/_____/_____

☐

8.____/_____/_____ ____/_____/_____

☐

9.____/_____/_____ ____/_____/_____

☐

10.____/_____/_____ ____/_____/_____

☐

Appointment 1 (SCREENING) SMOKING / ALCOHOL STATUS

Has the participant ever smoked? ☐ No ☐ Yes, Complete below

☐ Current Smoker

Participant’s average daily use: - Number of cigarettes : ___ ___- Number of cigars : ____ ___- Number of pipes : ___ ___

Smoked for ___ ___ months/years

☐ Former smoker

Smoked for ___ ___ months/years

Date when smoking ceased: __ __ / __ __ __ / __ __ __ __ (DD / MMM / YYYY)

When smoking, participant’s average daily use: - Number of cigarettes : ___ ___- Number of cigars : ____ ___- Number of pipes : ___ ___

Participant’s alcohol consumptionNotes:

Participant’s average consumption per week:- Number of units of wine : ___ ___- Number of units of beer : ____ ___- Number of units of spirits : ___ ___

Participant’s ilicit drug consumptionNotes:

Is the participant taking any controlled substances: Yes/No (Delete as appropriate)

Appointment 1 (SCREENING) INCLUSION/EXCLUSION CRITERIA

Exclusion Criteria Yes No N/A

1. Is the participant currently participating in a research project or psychotherapy? ☐ ☐ ☐

2. Does the participant have an inability to speak English? ☐ ☐ ☐

3. Does the participant currently practice meditation? ☐ ☐ ☐

4. Does the participant have a body mass index >34.9? ☐ ☐ ☐

5. Is the participant diagnosed with a severe and enduring mental health disorder (e.g. schizophrenia)? ☐ ☐ ☐

6. Does the participant have a severe/significant hearing impairment? ☐ ☐ ☐

7. Does the participant have a currently abuse alcohol/dependent on any substances? ☐ ☐ ☐

8. Does the participant have any other psychological, neurological or neurodegenerative disease? ☐ ☐ ☐

9. Does the participant have an intellectual disability? ☐ ☐ ☐10. Does the participant report a current suicide plan? ☐ ☐ ☐

If any of the above criteria is answered YES, the participant is NOT eligible for the study and must not be included in the study. Please list reason(s) for ineligibility for screen failure on Participant

Eligibility Review page.

Inclusion Criteria Yes No N/A

11.

Does the participant have a study partner who agrees to co-participate, assisting the person with dementia with MBI compliance and completing measures?

☐ ☐ ☐

12. Is the participant 55+? ☐ ☐ ☐

13.

Does the participant have a diagnosis of probable or possible dementia? ☐ ☐ ☐

14.

Did the participant score ≥18 in the Standardised Mini Mental State Examination? ☐ ☐ ☐

15. Did the participant score >5 in the PSQI? ☐ ☐ ☐

16. Does the participant have capacity to give fully informed consent? ☐ ☐ ☐

If any of the above criteria is answered NO, the participant is NOT eligible for the study and must not be included in the study. Please list reason(s) for ineligibility for screen failure on Participant

Eligibility Review page.

Appointment 1 (SCREENING) PARTICIPANT ELIGIBILITY REVIEW

End of Screening Appointment Checklist: Yes No1. Does the participant satisfy the inclusion and exclusion criteria to date? ☐ ☐2. Have all Screening Appointment procedures been completed? ☐ ☐4. Is the participant still willing to proceed in the study? ☐ ☐

Participant’s eligibility Investigator Sign-Off:

Is the participant eligible to take part in the study?

Investigator’s Signature: __________________ Date : __ __ / __ __ __ / __ __ __ __

(DD / MMM / YYYY)

Investigator’s Name: __________________

☐ Yes

☐ No, Please give reason for screen failure below

Reason(s) for screen failure:

1.

2.

3.

Date of intervention appointment: __ __ / __ __ __ / __ __ __ __ (DD / MMM / YYYY)

Date of follow up appointment: __ __ / __ __ __ / __ __ __ __ (DD / MMM / YYYY)

Appointment 1 (SCREENING) ENROLMENT

Participant Enrolment

Participant study Number allocated: ____ ____ ____

Appointment 1 (SCREENING) SLEEP DIARYSleep diary

Using this sleep diary template, please note down your loved one’s sleep behaviours each morning. You

needn’t worry too much about being exact- estimates are just fine.

Name of study participant: _____________ Date on Day 1: ____________________

Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7

Did you make any changes to the sleep

environment/routine?

1. At what time did they go to bed last night?

2.After settling down, how long did it take

them to fall asleep?

3.After falling asleep, about how many times

did they wake up in the night?

4.After falling asleep, for how long were they

awake during the night in total?

5. At what time did they finally wake up?

6. At what time did they get up?

7.

How would they rate the quality of their

sleep last night?

1 2 3 4 5

V. Poor>>V. Good

● Questions for the study partner:o How are you going to ensure that you complete the sleep diary each day?

o What might get in the way of completing the sleep diary?

o Problem solving strategies

o Proposed schedule

Appointment 2 (INTERVENTION) CHECKLIST



1. Sleep Diary Feedback ☐ ☐

2. Good Sleep Hygiene Psychoeducation ☐ ☐

3. Mindfulness CD ☐ ☐

Blank Page

Appointment 2 (INTERVENTION) SLEEP DIARY FEEDBACK

Was the sleep diary completed? ☐ No ☐ Yes ☐ Partially

Comments:

Has the study partner agreed to complete the sleep diary next week?

Appointment 2 (INTERVENTION) SLEEP DIARYSleep diary

Using this sleep diary template, please note down your loved one’s sleep behaviours each morning. You

needn’t worry too much about being exact- estimates are just fine.

Name of study participant: _____________ Date on Day 1: ____________________

Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7

Did you make any changes to the sleep

environment/routine?

1. At what time did they go to bed last night?

2.After settling down, how long did it take

them to fall asleep?

3.After falling asleep, about how many times

did they wake up in the night?

4.After falling asleep, for how long were they

awake during the night in total?

5. At what time did they finally wake up?

6. At what time did they get up?

7.

How would they rate the quality of their

sleep last night?

1 2 3 4 5

V. Poor>>V. Good

8.Did they listen to the mindfulness CD at

bedtime? (Y/N)

9. If no, why not?

Appointment 2 (INTERVENTION) GOOD SLEEP HYGIENE PSYCHOEDUCATION

Try to keep regular times for going to bed and getting up. Avoid sleeping in after a poor

night's sleep.

Avoid napping during the day.

Try to relax before going to bed.

Regular physical exercise is encouraged but avoid exercising in the 4 hours before

bedtime.

Maintain a comfortable sleeping environment: not too hot, cold, noisy, or bright.

Products containing caffeine (tea, coffee, cocoa, chocolate, soft drinks, etc.) should be

avoided in the 6 hours before bedtime. Caffeine is a stimulant meaning it can keep you awake.

Consider complete elimination of caffeine from the diet.

Avoid nicotine (including nicotine patches or chewing gum, etc.) in the 6 hours before

bedtime and when awake at night.

Avoid alcohol in the 6 hours before bedtime - although alcohol can promote sleep at first,

it can disrupt sleep later in the night.

Keep the bedroom quiet and darkened during the night but try to spend some time in

daylight during the day.

Keep the bedroom calm and tidy. If you are able to, sleep on a mattress, sheets and

pillows that are comfortable.

Avoid eating a heavy meal late at night.

Appointment 2 (INTERVENTION) MINDFULNESS BASED INTERVENTION

● Mindfulness relaxation has been shown to be a helpful tool in managing stress on older adults.

● Tense muscles are thought to reflect tension in the mind.

● Mindfulness means paying attention in a particular way: on purpose, in the present moment, and non-judgementally. This increases awareness, clarity and acceptance of our present-moment reality.

● Mindfulness helps to reduce physiological tension by attending to our bodies, noticing tension, and relaxing.

● Mindfulness can also help us to notice other things that we don’t usually notice.

● Sometimes when practicing mindfulness, our minds drift. This is OK, and happens sometimes. When you notice, just bring your attention back to the exercise.

● When practicing mindfulness, we try to do so without judging ourselves. Rather just notice the types of thoughts you are having.

● I will give you a CD to help you with the mindfulness exercise. This CD lasts approx. 14 mins, and has been specially designed for sleep. It was recorded by an experienced yoga and meditation practitioner at UCLA

● Before we listen do you have any questions?[Listen to CD]

● How was that? Do you have any questions?

● To the participant: o Are you willing to do this mindfulness exercise at bedtime every night?

● To the study partner: o Are you able to facilitate [participant] listening to this CD at bed time every

night?

o Are there any measures you might need to put in place

● To both:o How are you going to ensure that you listen to the CD each night?

o What might get in the way of listening to the CD?

o Proposed schedule?

Was the MBI training completed? ☐ No ☐ Yes ☐ Partially

Comments:

Appointment X Appointment N

Appointment 2 (INTERVENTION) APPOINTMENT REVIEW

End of Intervention Appointment Checklist: Yes No1. Have all Intervention Appointment procedures been completed? ☐ ☐2. Is the participant still willing to proceed in the study? ☐ ☐

Date of follow up appointment: __ __ / __ __ __ / __ __ __ __ (DD / MMM / YYYY)

Appointment 3 (FOLLOW UP) CHECKLIST



1 PSQI ☐ ☐

2. MBI Acceptability Interview ☐ ☐

3. Sleep diary Feedback ☐ ☐

4. Debrief ☐ ☐

5. Discharge ☐ ☐

Appointment 3 (FOLLOW UP) PITTSBURGH SLEEP QUALITY INDEX

Appointment 3 (FOLLOW UP) SLEEP DIARY FEEDBACK

Was the sleep diary completed? ☐ No ☐ Yes ☐ Partially

Appointment 3 (FOLLOW UP) MBI ACCEPTIBILITY INTERVIEW Welcome back. As part of the study, would be very helpful to record your feedback on the intervention o

that we can establish whether mindfulness is a reasonable task to ask of people Conversation 15-20 mins, please do let me know whether you would like to take some time

for a break in the middle. We would like to record this part of the appointment [Confidentiality statement]. Is it OK to

continue? I hope to collate the responses from all participants in the study to establish what about the

mindfulness programme was helpful, less helpful and any areas that could be improved to make it more helpful.

I have some questions to help guide us, but we can expand on them if needed. [play gbMBI sample] Let’s spend some time talking about your experience of the mindfulness CD, ok?

What was it like being recruited/contacted/contacting me to participate in the study? What did you think taking part in the study would be like? Did this change later on in the

study? What made you agree to take part in the study? What did you think of mindfulness before I saw you the first time? After I came to see

you the first time? Now we sre at the end of the study? Between the first and second appointments you had to wait to get the mindfulness CD.

What was that like? What was it like the first time you used the CD? Was it what you expected? Were there any difficulties you needed to overcome in order to listen to the CD? How did

you overcome them? What changes did you need to make so that you could listen to the mindfulness CD?

What did you think about listening to the CD at bed time? Was it easy or hard to follow? What do you think might have made listening to the CD at bed time more feasible? What were your thoughts about what was said in the CD? What did you like best about

what was said? What did you like least about what was said? Do you have any feedback on the voice or language used? What did you think about the music? Do you have any other comments about what you heard on the CD? Did you have any worries about taking part in the mindfulness intervention? Do you think the mindfulness intervention helped improve your sleep quality? Were there

any changes in how long it took you to get to sleep? Were there any changes in how long you slept for? How many times you woke up in the night? Were there any changes in how much energy you had in the daytime?

Do you think you will continue with the mindfulness CD? What words would you use to describe the mindfulness intervention? Did you enjoy it?

Was there anything you didn’t like about it? How did you get on with the sleep diary? How feasible was it to complete? How possible

was it to remain accurate? How did you get on with implementing the sleep hygiene? Which parts did you

implement and why? Which parts didn’t you implement and why? How well did it fit with the mindfulness intervention?

What do you think the barriers could be to doing this study? What do you think could stop some people being able to take part in this study?

Is there anything else you would like to tell me about taking part?

Is there any way the study of mindfulness CD could be made better?

I have asked you a few questions, are there any questions that you have about the mindfulness programme?

Appointment 3 (FOLLOW UP) DEBRIEF

Debrief form

Thank you for participating in the Mindfulness for Sleep Disturbance in older adults with dementia study.

The study aimed to investigate the usefulness of a short mindfulness-based intervention in the treatment of sleep disturbance in PwD. Dementia affects a vast number of older adults, and many experience sleep disturbance of some description. Sleep disturbance in those with dementia can take many forms. Some examples are: hypersomnia (excessive daytime sleepiness) insomnia (difficulties initiating and maintaining sleep) rapid eye movement (REM) sleep behaviour disorder (acting out of dreams during REM) and “sundowning syndrome” (increased disorientation, agitation and hallucinations in the late afternoon or night). Research also shows that there are increased disturbances in the general efficiency of sleep in people with a diagnosis of dementia.

Research suggests that mindfulness-based interventions help other groups with sleep disturbance. The current study aimed to identify whether the benefits of mindfulness on sleep extends to older adults with a diagnosis of dementia. We did this by comparing the results of the sleep quality questionnaire and sleep diary at the beginning and end of the study.

Since this research is novel, we were also interested in of how the mindfulness-based intervention was for you. That is, whether the intervention was acceptable. This is so that if we do a similar study in the future, we can improve the delivery of the intervention. We would be using your feedback from our recorded conversation to direct the development of the intervention.

We were interested in whether the study design presents a feasible way of understanding the benefits of the mindfulness intervention. To determine this, we are very interested in the final question on the sleep diary (Did s/he listen to the mindfulness CD at bedtime?), and also thinking about the changes you made in order to incorporate the mindfulness intervention.

As was explained at the beginning of the study, this study is novel, however we anticipate that mindfulness in combination with the good sleep hygiene guidelines will be acceptable and feasible. We also hope to make predictions about the efficacy of the mindfulness-based exercise in future studies.

It is our intention to develop a summary of results sometime after the study is completed. You are invited to receive a copy of the summary of results and you may express your interest in the follow up appointment. You may also contact:

Name: Dr Paul Davis Name: Mrs Melody SmithAddress: Faculty of Health and Medical Sciences, AD Building, University of Surrey, Guildford, Surrey, UK, GU2 7XH

Address: Faculty of Health and Medical Sciences, AD Building, University of Surrey, Guildford, Surrey, UK, GU2 7XH

Telephone: 01483 68 6927 Telephone: 01483 68 6927Email: [email protected] Email: [email protected]

if you have any questions regarding the study.

Thank you once more for your kind cooperation.

Appointment 3 (FOLLOW UP) APPOINTMENT REVIEWEnd of Intervention Appointment Checklist: Yes No1. Have all Intervention Appointment procedures been completed? ☐ ☐

DISCHARGE / STUDY COMPLETION

Did participant complete the study?

☐ Yes, Please provide date of last visit:

__ __ / __ __ __ / 2 0 __ __

(DD / MMM / YYYY)

☐ No, Please provide date of withdrawal and complete below:

__ __ / __ __ __ / 2 0 __ __

(DD / MMM / YYYY)

Early Withdrawal: please tick most appropriate reason for participant not completing the study:

☐ Adverse Events related: please state related AE: ____________________________________ (add details to AE page)

☐ Participant’s decision, specify: __________________________

☐ Investigator’s decision, specify: __________________________

☐ Lost to follow up

☐ Patient deceased

☐ Other, specify: __________________________

Appendix 4: gbMBI (Body Scan for sleep) transcript (13:50 mins)

This is a guided Body Scan meditation to help you prepare for sleep

As you do the meditation you may find yourself drifting off to sleep

This is fine

So you can allow the meditation to turn off on its own

If you notice thoughts such as worries or concerns arising that take your attention away

from the meditation

This is also normal

See if you can redirect your attention

Back to the Body Scan

Gently letting go of these thoughts, if it’s possible

We’ll be noticing our body lying down on the bed

We’ll be feeling the body's sensations that are present

Scanning the body for any kinds of obvious sensations

Like vibrations, tingling sensation, heaviness, pressure, movement, heat, coolness

We’ll be noticing these sensations without trying to change them

Or make them different

Simply bringing a mindful attention of curiosity and openness to the present moment

If you notice yourself starting to think about the sensation

Or think about something else

See if you can simply come back to the feelings and sensations present in your body

We can begin the mediation

By noticing the sensations at the top of our head

So simply bring your attention to the top of your head

And notice what you feel

You might notice some vibration or pressure

And then allow your attention to notice your skull

As it make contact with the bed or the pillow

There might be a sense of pressure

Weight

You might notice some other sensation

Simply be curious about these sensations

Feeling them

Sometimes when you encounter a sensation there may be some tension

If you can, allow it to gently relax

If that doesn’t seem possible, simply notice what it is that you feel

And notice your face area

Your forehead

Eyes

Nose

Notice your cheeks

And mouth

There may be sensations of tingly, temperature, tightness,

Let it all be there

Be curious about your experience

Then begin to notice the sensations in your throat

And neck

And become aware of anything that’s present for you

And your shoulder area

If at any point you notice tension arising

Sometime in the act of noticing it you may find yourself releasing the tension and

relaxing

If it feels extremely tense you can breathe gently

Directing that breathing into that area to allow it to soften

And if it still stays tense just continue on with the Body Scan

At this moment you’re aware of the sensations in your left shoulder

Bring your attention there

And then let your attention go down your arm

Noticing any vibration, tingling, heat, coolness, pressure, movement,

As you reach your elbow

Your lower arm

And then your hand

There are often quite a few sensations in your hand area

Notice your hands and fingers

Be curious and open to the sensations that are present

Also allowing your hands to soften and relax

Now bring your attention up to your right shoulder

Again noticing any sensations that might be present

And then start to go down your right arm

Feeling vibration, tingling, movement

Noticing your elbow

Your forearm

And then also your hand and fingers

Again lots of sensations are usually present in our hands and fingers

But if at any point, there’s no sensation

Just notice the absence of sensation

Now let your attention go back to the top of your shoulders

To your back

Notice the shoulder area soften

Breathe

Begin to bring your attention down your back

You can zig-zag it across your back

Or make an up and down movement in your mind

Sometimes there’s strong sensation in our back

The sensation of touching the bed

Pressure, weight

Sometimes there’s not much sensation at all

Can you be open and curious to whatever the experience is

Kind to yourself no matter what

You can notice your upper back

Your midback

And notice the sensations in your lower back as well

Making sure to breathe

If thoughts crop up as you’re doing this

Worries, concerns

Once again, see if you can let them go

Let them be like clouds floating in the sky

Moving across your mind, but don’t take them so personally

Just let them go, if possible

Or at the very least come back to my words and this Body Scan

Now bring your attention to the top of your chest area

And let yourself gently scan your chest

Down to the upper ribcage

Into the stomach area

See if you can soften your stomach

Breathe more deeply

Directing some breath into that area

Allowing it to soften and relax

You can notice your pelvis

The whole pelvic area

The places where your body connects with the bed

Feeling whatever sensations are present

And now gently bring your attention to your left hip

And we’ll start to bring our awareness down our leg

Noticing the sensations in our thigh

You can circle your attention gently around the leg

Noticing whatever is obvious to you

Not forgetting to breathe

Bringing this kind and curious attention to your leg

And then to your knee

And left calf

Noticing whatever is present

Vibration, tingling, heat

Itching, warmth, coolness, heaviness

Let it be here, whatever it is

And noticing your ankle

Foot

And toes

There may be quite a bit of sensation in your feet

Possibly

Maybe not

Become aware of whatever is here for you

Now come back up to your right hip

Notice the sensations in your right hip

And again bring your attention down your right thigh

Feeling whatever is present

You can circle your attention or notice it in any other way that makes sense to you

Feeling the vibration and tingling

Heat, heaviness, movement

And to your knee

And down to your leg

Your calf

Feeling the sensations present

Scanning your body

And then down to your right ankle

Foot

And toes

Now that you’ve scanned your body

You’re welcome to start again

You can continue listening to the CD for another time

Or you can continue on your own

This time if you wish you can start at your feet

And go back up through your body till you get to the top of your head

Feel free to scan your body up and down

As many times as it’s helpful to you

Appendix 5: Telephone pre-screening questionnaire script

Hi there, my name is Melody Smith and I am calling from the Mindfulness for sleep disturbance

for dementia research study.

I am calling you because you:

Trust 1: You have told the research team at [university] that you are interested in hearing more

about Dementia research.

Trust 2: sent a form back telling us you were interested in hearing more about the sleep study.

Join Dementia Research: are signed up with the join dementia research register and you

came up as a match for our sleep study.

Trust 3: had an appointment at the memory service, and one of the nurses there told us you

wanted to hear more about the sleep study.

Would it be better to speak to you or to a family member about the research study?

Before we go any further, I’d like to ask you some questions to see if the study would be right for

you. Could I go ahead and ask you (or family member) those questions now?

Questions:

1. Do you have a diagnosis of dementia?

Yes – Move on to Q2 - yes

No - If no (This study is not right for you/or family member – Thank you for your

time)

Unsure - Ask if they’re able to check or I will call back on [study hotline]. Or offer

a call back at an agreed time.

2. Do you live with anyone who could be/act as your study partner?

Yes – Move on to Q3 (Pre-screen questions) - yes

No - If no (This study is not right for you/or family member – Thank you for your

time)

Unsure - Ask if they’re able to check and can call back on [study hotline numner].

Or offer a call back at an agreed time.

3. [Telephone call pre-screening questions] (a-e yes to at least one and must

say no to f-h in order to be eligible)

a. Has there been any changes to your sleep pattern since you started to

have memory problems?

(Note: Either difficulty falling asleep, staying asleep, feeling sleepy in the day

time or dozing off during the day?)

b. Do you wake up feeling tired or feel very sleepy during the day even

though you've had enough sleep?

d. Do you ever feel more confused during the night time? yes

e. Have you ever woken up, as though it’s morning to find that it was still the

middle of the night.

f. Have you ever been diagnosed with sleep apnea

g. Do you have heart disease, lung disease or a nerve disorder?

If ineligible: Ah, it doesn’t look like this study would be right for you, because

people on the

study need to have ………………………./need to not have

………………………… or Sounds like your/his sleep is really good/not being effected.

Thank you very much for your time, but we won’t need to take this any further.

[end call]

If eligible: It looks like this study could be for you. Could I tell you more about the

study and what the study involves?

We are doing this study because sleep problems are a serious issue, and

especially for many people in later years and particularly people with a diagnosis of

dementia and those close to them. We know that research into mindfulness for sleep

disturbance in older adults without dementia shows that it could be a helpful new

treatment.

(What are the main aims of the study?)

The main purpose of this research is to test a therapeutic treatment called

"Mindfulness" in reducing problems with sleep and their symptoms, specifically in

people with a diagnosis of a dementia.

Mindfulness is inspired by the benefits of meditation, and involves sitting or lying

quietly while paying attention to the senses. Mindfulness can take some practice before

the benefits are felt but in this study we will give you clear training and a guided

mindfulness exercise CD to help you learn the techniques.

Does this make sense so far? [response]

(What does it involve for a participant?)

So, you and a study partner will be asked to attend 3 face-to-face appointments

in total, we can arrange this now or at a later date. Each appointment will last about an

hour to 90 minutes, and breaks can be incorporated into each appointment.

Appointments will take place every week for 3 weeks.

There is more information. Do you mind if I can send this information sheet to

you?

Excellent – may I confirm the address we have for you in correct?

Someone will call you back in a week or so/shall we book in an initial

appointment

Thank you very much for your time.

Appendix 6: GSH leaflet provided to dyads

Ten steps to improved sleep hygiene

Sleep Hygiene is a set of strategies for people who have trouble sleeping. Good sleep hygiene

means doing things that might improve sleep and avoiding things that might disturb sleep. You

will find these strategies below. Try to follow this guidance immediately.

Try to keep regular times for going to bed and getting up. Avoid sleeping in after a poor night's sleep.

Avoid napping during the day.

Try to relax before going to bed.

Regular physical exercise is encouraged but avoid exercising in the 4 hours before bedtime.

Maintain a comfortable sleeping environment: not too hot, cold, noisy, or bright.

Products containing caffeine (tea, coffee, cocoa, chocolate, soft drinks, etc.) should be avoided in the 6 hours before bedtime. Caffeine is a stimulant meaning it can keep you awake. Consider complete elimination of caffeine from the diet.

Avoid nicotine (including nicotine patches or chewing gum, etc.) in the 6 hours before bedtime and when awake at night.

Avoid alcohol in the 6 hours before bedtime - although alcohol can promote sleep at first, it can disrupt sleep later in the night.

Keep the bedroom quiet and darkened during the night but try to spend some time in daylight during the day.

Keep the bedroom calm and tidy. If you are able to, sleep on a mattress, sheets and pillows that are comfortable.

Avoid eating a heavy meal late at night.

Keep your bedroom for sleeping and sex; avoid watching TV, listening to the radio, or eating in your bedroom. (for this study, the electronic device used to play the mindfulness clip and the sound of the mindfulness are permitted.)

Avoid watching or checking the clock throughout the night.

Appendix 7: Principles of quality qualitative research (Yardley, 2000)

Due to the lack of concrete appraisal tools, appraising the quality of qualitative

research is inherently more complex than quantitative research. There have been

numerous checklists, guidelines and summary frameworks that have attempted to

establish ways to assess the usefulness of qualitative research (Walsh & Downe, 2006).

Yardley (2000) provides 1 such framework that stipulates the four principles of good

quality qualitative research: sensitivity to context, commitment to rigour, transparency

and coherence, and impact and importance. The incorporation of Yardley’s principles

into the current research aimed to improve the integrity and credibility of this study.

Below, the ways in which this study attempted to be guided by these four principles are

further expanded upon:

Sensitivity to context

This study was designed to explore the feasibility, acceptability and preliminary

efficacy of a NPI for sleep disturbance in people with a dementia- namely a

mindfulness-based intervention. To this end, prior to the development and indeed the

commencement of the study, the evidence base was queried for NPIs that have been

trialled to alleviate of SDi in PwD. Therefore, all of the previous relevant clinical trial

research in this very specific area was engaged with. It was clear from my literature

search that sleep problems in older people continues to be pervasive problem with no

clear treatment. A limited number of NPIs had been trialled including Bright Light

Therapy, CBT, exercise, multi component treatment programmes (combining exercise,

CBT and Bright Light Therapy) and 1 Mindfuness Based Intervention named Tai Chi

Qigong. In addition, the evidence base was queried for NPIs that have been studied to

help alleviate sleep disturbance in adults and older adults without dementia. Last, the

evidence base was queried for MBIs used to help PwD generally, to ascertain whether

MBIs are possible within this group, and any other difficulties it could assist with.

In doing the aforementioned literature searches, an understanding of the context

was gained leading to an overview of and ability to consider a number of potential NPIs

that could be helpful, in practice, for PwD. Further, it lead to a consideration of several

methodologies, and the development of a study that would contribute to the evidence

base and future research.

The development of this study, and indeed the broad research questions, were

informed by the evidence base and the aims of the MBI. However, research into MBIs

for SDi in dementia is extremely scarce so it was important to deduce from participants

answers to the specific questions laid out in the aims of this study in order to ascertain

whether further research (i.e. a clinical trial) would be justified.

The sociocultural context of this study was important to continually consider.

Despite restricting the study to participants with mild dementia, the experiences of PwD

in terms of their mental health and cognitive abilities can vary considerably. Moreover,

the dynamics between PwD and study partners varied naturally, and was likely further

varied by the fact that some dyads were child-parent and others were spouse-spouse.

These factors may have impacted recruitment or influenced the type of dyad that was

referred (by Trust staff) and recruited to the study beyond the inclusion and exclusion

criteria. Dynamics between dyads may also have impacted what was spoken and

indeed not spoken about during the interviews. Though I have worked in dementia

research previously, I do not have experience of caring for an elderly relative, nor have I

had personal experience of a family member being diagnosed with dementia. Thus, my

lack of awareness may have influenced the interviews and my interpretation of the data

are presented.

Commitment

In addition to sensitivity to the scientific and socioeconomic context and the

previous experience of the researcher in sleep research in PwD, the principle of

commitment was followed through becoming immersed in the interview transcript data.

Each transcript was read and re-read several times to gain familiarity and develop

codes and themes. The interviews incorporated the views of both PwD and study

partners to gain a more triangulated dataset. Reflective writing and discussions around

such assisted in my ability to extract information from the dataset.

Rigor

To skilfully and appropriately employ the qualitative method of analysis, Thematic

Analysis, Braun and Clarke’s (2006) guide was followed, which involved consulting with

it over several months as data was analysed. The application of the Thematic Analysis

and competence in this method was developed through supervision, meetings with

peers also using this method, doctoral level qualitative research methods teaching and

through consulting with published articles also using this method.

Coherence

Since the aim of this research is to address specific questions around the

experiences of dyads engaging with a MBI, with the aim of justifying (or indeed refuting)

future research, thematic analysis is a good fit. Thematic analysis is a flexible

qualitative method, lending itself to deductive methods from an essentialist position. As

such, it has the ability to provide, rich perspectives on the specific questions asked of

this study, making it a coherent method of analysis.

Transparency

Through the employment of Thematic Analysis, greater transparency was

facilitated, as dyads were able to offer their subjective opinions and experiences, which

go beyond the numbers inherently provided by quantitative research. Regular

supervision throughout the study assisted in the implementation of the principle of

transparency. Each interview was audio recorded and each transcript was spot checked

for accuracy by two separate people (those transcribed by the researcher were checked

by a supervisor or peer; those transcribed by a transcription service was checked by the

researcher). At each stage of development, codes and themes were discussed with at

least 1 supervisor. Thematic maps found in Appendices 9 and 10 provide a visual

representation of how themes were developed and refined over time. At least 1 excerpt

directly taken from the transcripts is provided in the ‘Results’ to support each theme

presented.

Impact and importance

The utility of this study is justified in the ‘Introduction’ and the ‘Discussion’

sections of this thesis. To summarise, SDi in dementia appears to be a pervasive and

prominent problem, which worsens with dementia severity and increases the chance of

health problems in PwD and caregivers, leading to earlier institutionalisation, poorer

quality of life and higher cost care. Pharmacological interventions are not a viable long-

term solution, and in fact, pose risks such as side effects and dependency. Non-

pharmacological interventions that have been researched thus far are either

inconclusive with regards to their efficacy, or too costly to be implemented across our

stretched NHS. The current study builds on the scarce literature in this area and

provides a pilot study of a pragmatic, cost effective potential treatment- a Mindfulness-

Based Intervention- which could provide alleviation from SDi and the associated effects

for PwD and their caregivers.

Appendix 8: Interview Schedule

Welcome back. As part of the study, would be very helpful to record your feedback on the intervention o

that we can establish whether mindfulness is a reasonable task to ask of people Conversation 15-20 mins, please do let me know whether you would like to take some time

for a break in the middle. We would like to record this part of the appointment [Confidentiality statement]. Is it OK to

continue? I hope to collate the responses from all participants in the study to establish what about the

mindfulness programme was helpful, less helpful and any areas that could be improved to make it more helpful.

I have some questions to help guide us, but we can expand on them if needed. [play gbMBI sample] Let’s spend some time talking about your experience of the mindfulness CD, ok?

What was it like being recruited/contacted/contacting me to participate in the study? What did you think taking part in the study would be like? Did this change later on in the

study? What made you agree to take part in the study? What did you think of mindfulness before I saw you the first time? After I came to see

you the first time? Now we sre at the end of the study? Between the first and second appointments you had to wait to get the mindfulness CD.

What was that like? What was it like the first time you used the CD? Was it what you expected? Were there any difficulties you needed to overcome in order to listen to the CD? How did

you overcome them? What changes did you need to make so that you could listen to the mindfulness CD?

What did you think about listening to the CD at bed time? Was it easy or hard to follow? What do you think might have made listening to the CD at bed time more feasible? What were your thoughts about what was said in the CD? What did you like best about

what was said? What did you like least about what was said? Do you have any feedback on the voice or language used? What did you think about the music? Do you have any other comments about what you heard on the CD? Did you have any worries about taking part in the mindfulness intervention? Do you think the mindfulness intervention helped improve your sleep quality? Were there

any changes in how long it took you to get to sleep? Were there any changes in how long you slept for? How many times you woke up in the night? Were there any changes in how much energy you had in the daytime?

Do you think you will continue with the mindfulness CD? What words would you use to describe the mindfulness intervention? Did you enjoy it?

Was there anything you didn’t like about it? How did you get on with the sleep diary? How feasible was it to complete? How possible

was it to remain accurate? How did you get on with implementing the sleep hygiene? Which parts did you

implement and why? Which parts didn’t you implement and why? How well did it fit with the mindfulness intervention?

What do you think the barriers could be to doing this study? What do you think could stop some people being able to take part in this study?

Is there anything else you would like to tell me about taking part? Is there any way the study of mindfulness CD could be made better?

I have asked you a few questions, are there any questions that you have about the mindfulness programme?

Appendix 9: Earlier thematic map for acceptability of gbMBI

Appendix 10: Early thematic map for perceived efficacy of the gbMBI

Appendix 11: Further ethical considerations

It was explicitly explained to dyads that participation was voluntary and they

could withdraw from the study at any point, without it affecting their healthcare or legal

rights. Informed consent was gained from PwD and SP prior to beginning the study. A

capacity assessment checking PwD’s ability to retain information about the study, weigh

up benefits and drawbacks of participation and communicate their decision to

participate, was conducted with PwD as part of the consent process.

Personal data were handled according to the Data Protection Act (1998) and

Surrey Research Data Management Policy. Qualitative interviews were recorded on a

dictaphone and transferred to an encrypted memory stick, before being uploaded to the

secure UoS server. Interviews were transcribed, anonymised and audio recordings

destroyed. The employed transcription service was subject to a Non-Disclosure

Agreement.

Dyads consented to their host Trust or GP being informed of their participation in

the study. Otherwise, their participation was confidential and this would only have been

broken if the researcher was authorised to do so or if they shared something that

jeopardised someone’s safety.

Support for mental health concerns was beyond the scope of the study. People

with dementia expressing such concerns, or scoring in the clinical ranges for depression

and anxiety were informed about this, and if in agreement, a letter was sent to their GP

requesting further support. Dyads were advised to see their GP for help regardless of

the letter.

Appendix 12: A table showing the reasons for dyad ineligibility by recruitment source

Recruitment statusJoin

Dementia Research

Trust 2 Trust 1 Trust 2 Unknown Total

Ineligible: Caregiver agreed; participant declined 2 4 6Ineligible: Caregiver declined; participant agreed 1 1Ineligible: Caregiver declined; participant declined 2 4 6Ineligible: Does not have a dementia diagnosis 1 6 2 9Ineligible: English not first Language 1 1Ineligible: Going on extended holiday 1 1 2Ineligible: Has heart problems 1 1Ineligible: Lives too far away 1 1Ineligible: No sleep problems 9 17 2 28Ineligible: No study partner 1 1 1 3Ineligible: Participant unwell/deceased 1 3 1 5Ineligible: Participating in another study 2 2 4Ineligible: Severe dementia 3 3Ineligible: Severe hearing problems 1 1 2Ineligible: Unable to contact 5 4 13 1 1 24Recruited 2 1 4 2 9

Total 25 8 60 11 1 105

Part 2: Literature Review

Non-Pharmacological Interventions for Sleep Disturbance in

Dementia: A Systematic Literature Review

Abstract

Dementia prevalence is increasing alongside a rise in the average

age of the population. Sleep disturbance (SDi) is prevalent in people with

dementia (PwD) and is associated with poorer quality of life, cognition and

psychological wellbeing. Pharmacological interventions pose serious side

effects. Previous reviews highlighted a paucity of high-quality research into

non-pharmacological interventions (NPIs). This review aimed to provide an

up-to-date synthesis of high-quality studies of NPIs for SDi in dementia,

restricting included studies to randomised controlled trials (RCTs).

Online databases (Web of knowledge, Pubmed/Medline, Cochrane

Collaborative Central register of Controlled trials) were searched (October

2016) for RCTs. References of articles and reviews were also queried.

RCTs included PwD aged 55+, an NPI and pre- and post-treatment SDi

outcomes to be eligible for inclusion in the review. Analysis of study quality

was guided by the Cochrane Handbook for Systematic Reviews of

Interventions Risk of Bias tool.

14 articles investigating Bright Light Therapy (BLT), activity, mind-

body and multi-component (BLT, activity and Cognitive Behavioural

Therapy- NITE-AD) interventions were reviewed. Most studies were of

“low-moderate methodological quality” suggesting high presence of bias,

reducing conviction of results. Heterogeneity in samples suggested

presence of confounding variables. Variability in SDi parameters reported

across studies prevented synthesis.

There was no consistent evidence for BLT and contradictory

evidence for activity. There was preliminary evidence for a mind-body

treatment and replicated evidence for multi-component treatment (NITE-

AD). NITE-AD and mind-body treatments are resource-intensive, limiting

applicability. Further research is needed to develop deliverable NPIs;

future researchers should prioritise producing high-quality studies.

Introduction

Dementia is a progressive neurodegenerative disease comprising

several subtypes (e.g. Alzheimer’s disease; Table 1), and is most

prevalent in people over 65 (Prince et al., 2014). As the general population

ages, dementia prevalence is expected to rise (Health and Social Care

Information Centre, 2016). People with dementia (PwD) have care needs

(e.g. with performing activities of daily living), therefore a rise in dementia

prevalence will lead to an increase in pressure on PwD, families and

healthcare services to meet these needs (Lewis et al., 2014).

Table 1 Prevalence of dementia by subtypeSubtype PrevalenceAlzheimer’s diseaseVascular dementiaMixed dementiaDementia with Lewy BodiesFrontotemporal dementiaParkinson’s DementiaOther

62%17%10%4%2%2%3%

Note. According to the Alzheimer’s Society (Knapp et al., 2007)

Up to 97% of PwD have one or more behavioural and psychological

symptoms of dementia (BPSD), increasing in severity alongside cognitive

decline (Thompson, Brodaty, Trollor & Sachdev, 2010; McKeith &

Cummings, 2005). BPSDs include delusions, hallucinations,

agitation/irritability, apathy, elation, anxiety, disinhibition and aberrant

motor behaviour and sleep disturbance (SDi; Kales, Gitlin & Lyketsos,

2015). BPSDs are increase distress and complexity of dementia, and

consequently contribute to poorer health in PwD and increased cost of

care to the PwD, family and the state (Finkel, 2000; Tible, Riese,

Savaskan & von Gunten, 2017). SDi is among the most intense BPSD

(after appetite problems, aberrant motor behaviour and apathy; Fauth &

Gibbons, 2014). Severity of SDi in PwD is strongly correlated with their

ability to perform activities of daily living (D’Onofrio et al., 2012). SDi

increases caregiver stress and burden, which can overwhelm and reduce

the quality of life of caregivers (Finkel, 2000). Consequently, SDi can

diminsh the quality of life of PwD and encourageearlier institutionalisation

of PwD (Pollak & Perlick, 1991). Evidence suggests institutionalisation

leads to increased SDi and accelerated cognitive decline in PwD,

suggesting SDi can precipitate excess disability (van Someren et al.,

1996; Wilson et al., 2007; Finkel, 2000).

Defining good sleep and sleep disturbance (SDi)

Good sleep is tentatively defined as “…a multidimensional pattern

of sleep-wakefulness, adapted to individual, social and environmental

demands, that promotes physical and mental well-being” (Buysse, 2014;

pp. 12). There is a lack of understanding of the function of sleep, making

good sleep difficult to operationalise. Nevertheless, it is accepted that

good sleep is characterized by subjective satisfaction, appropriate timing,

low-risk duration, high efficiency and sustained alertness during

wakefulness (Rechtschaffen, 1998; De Ford, 1989).

SDi is defined as deficits in total night-time sleep duration,

subjective poor-quality sleep and increased night-time wakefulness

(Robotham, Chakkalackal & Cyhlarova, 2011). There are several

manifestations of SDi in the general population (Table 2). 62% of adults

have SDi and SDi is negatively correlated with increasing age, implying

older people are more at risk (Robotham et al., 2011). SDi reduces

psychosocial functioning in older people (Robotham et al., 2011).

Prevalence, manifestation and aetiology of SDi in dementia

Evidence suggests SDi affects 14%-69% of PwD (dependent on

SDi definition; Zhao et al., 2016). However, SDi is more prevalent in some

subtypes than others (e.g. 44% of people with Alzheimer’s disease report

SDi; approximately 90% of PwD with Lewy bodies and Parkinson’s

disease have SDi; Morin et al., 2007; Porter, Buxton & Avidan, 2015).

PwD experience a spectrum of symptoms of SDi (Table 2), with

some occurring more frequently among specific subtypes (e.g. more

nightmares, hallucinations, excessive daytime sleepiness and sleep

attacks in people with Parkinson’s disease, taking Levadopa; Zhao et al.,

2016; Larsen & Tandberg, 2001). Up to 66% of PwD are affected by

“sundowning syndrome” (Gallagher‐Thompson et al., 1992). There are

multiple conceptualisations of sundowning syndrome, but generally it is

described as increased agitation, confusion and disorientation in the

afternoon, evening and night (Khachiyants, Trinkle, Son & Kim, 2011).

This, an increased prevalence of sleep apnoea, and a reduction in rapid

eye movement, slow wave and night-time sleep, suggest disturbances in

sleep efficiency in PwD (Bombois, Derambure, Pasquier & Monaca, 2010).

Explanations for changes in sleep in PwD are inconclusive. One

hypothesis is that in PwD, signals sent from the suprachiasmatic nucleus

(regulates sleep-wake cycle), to the pineal gland (governs melatonin

Table 2 Main types of sleep disturbance in the UK adult population

Type Brief Description

Pro

blem

s in

itiat

ing

or Insomnia

Most prevalent sleep disorder among general population. Acute (<1 month) or chronic (>1 month) difficulty initiating or maintaining sleep or poor-quality

sleep. A psychophysiological problem understood to be triggered by patterns of cognition, affect and behaviour that maintain a vicious cycle of poor sleep.

OversleepingRare form of SDi: frequent excessive sleeping; lengthy sleep episodes or

regularly occurring voluntary or involuntary naps. Oversleeping has been linked with depression, diabetes and cardiovascular disease.

Hypersomnia An overwhelming feeling of sleepiness, or sense that one is not fully awake for hours after getting up.

Narcolepsy Overwhelming, unexpected bouts of daytime sleepiness (sleep attacks). May present with “cataplexy” (sudden loss of muscle tone/short-term paralysis).

Pro

blem

s du

ring

slee

p

Snoring Relaxation of the tongue causing partial obstruction of the airways, resulting in noise-producing vibration. Can cause problems for sleep partners of snorers.

Sleep Apnoea

Primary Sleep disorder which occurs in 2%-7% of adults and is more common in older people, and those who are overweight. Triggered by a respiratory

problem and characterised by periods of obstruction of the airways during REM sleep, causing sufferers to stop breathing for up to minutes at a time. Sufferers

may resume breathing during sleep or may be woken by difficulty breathing. Has potential to starve brain of oxygen, causing neurological insults.

Nightmares Intense, vivid, frightening dream (during REM sleep). Causes the sleeper to wake suddenly in a panic.

Sleep ParalysisWaking during or shortly after REM sleep (often as a result of a nightmare) but experiencing temporarily paralysis (due to the inhibition of muscle stimulation

by the brain during REM sleep).

Night Terrors

It is estimated that 2.2% of adults experience night terrors. Experiencing of fear and panic during deep sleep (often because of a nightmare). Sufferers are

often unable to recall the night terror the following morning. Can be extremely distressing for sleep partners and caregivers.

Sleepwalking

Affects 2-5% of adults, and up to 15% of children. The occurrence of walking during deep sleep. Sufferers are often unable to recall the sleepwalking the

following morning. Risk of injury indoors, which increases if people leave home. Some sufferers engage in activities when sleepwalking, such as

cleaning. Also related to bedwetting.

Sleep talking Can range from incoherent utterances to eloquent speech at various intervals during deep sleep. More problematic for sleep partners.

Teeth Grinding 8.2% of the population are thought to grind their teeth during sleep. Characterised by a clenching of the jaw and grinding of the teeth during sleep.

REM behaviour disorder

Rare disorder that tends to affect those over 50 years. Characterised by lack of inhibited muscle tone during REM resulting in the acting out of dreams. Can be

very disruptive for sleep partners.

Periodic Limb Movement Disorder

Motor disorder. An intense or prolonged set of involuntary jerks, usually in the legs, whilst sleeping. Occurs in approximately 3.9% of the population.

Adapted from The Mental Health Foundation information (Robotham et al., 2011)

secretion) are weakened. This results in significantly reduced secretion of

melatonin (sleep-inducing hormone), creating problems initiating and

maintaining sleep (Piggins & Loudon, 2005; Wu & Swaab, 2005).

Conversely, evidence suggests SDi is a side effect of acetylcholinesterase

inhibitors, a common pharmacological treatment for cognitive symptoms of

Alzheimer’s disease (Stahl et al., 2004). Social factors (e.g. poor living

conditions), physical health problems, polypharmacy and comorbid

psychiatric conditions are also risk factors for SDi and prevalent in PwD

(Neikrug & Ancoli-Israel, 2010).

In addition to the detrimental effects of BPSDs explained in Figure

1, SDi is correlated with increased psychosocial (e.g. depression, anxiety,

isolation), behavioural (e.g. aggression, aberrant motor behaviour) and

cognitive symptoms (poor memory consolidation, attention and executive

functioning), potentially exacerbating dementia (Cipriani, Lucetti, Danti &

Nuti, 2015). Treatments to alleviate SDi would increase the psychosocial,

behavioural and cognitive functioning of PwD.

Pharmacological treatments

Hypnotics (e.g. Trazodone) and benzodiazepines are licensed for

use in dementia and are often used in the treatment of SDi (Levinson &

General, 2017). Evidence suggests the preliminary efficacy of low-dose,

short-term (<4 weeks) hypnotics in PwD (McCleery et al., 2016). However,

there is no evidence base for their long-term use. Moreover, research

shows they trigger accelerated cognitive decline, increased falls risks,

tolerance and dependency in PwD (McCleery et al., 2016). Therefore, the

National Institute for Health and Care Excellence (NICE) guidance advises

caution around prescribing these medications to treat SDi in PwD (NICE,

2018). Similarly, evidence suggests synthetic melatonin increases

negative affect, agitation and aggression in PwD, and therefore, it is not

advised (Haffmans et al., 2000). Thus, research into the treatment of SDi

in dementia has moved towards consideration of non-pharmacological

interventions (NPIs), as they may cause fewer adverse effects.

Previous reviews of Non-pharmacological Interventions (NPIs) for

SDi in dementia

Forbes and colleagues published a review and an updated review

solely of RCTs of Bright Light Therapy (BLT) for SDi in dementia (Forbes

et al., 2009; Forbes, Blake, Thiessen, Peacock & Hawranik, 2014). BLT is

the prescribed exposure to light (e.g. fluorescent lamps, sunlight). Ambient

BLT involves lighting a room with a florescent lamp. Direct BLT requires

participants sit directly in front of a fluorescent light (Montgomery &

Dennis, 2002). BLT is thought to work by increasing light stimulation,

which is thought to make the contrast between day and night more

prominent, promoting the timely release of hormones tasked with

maintaining circadian rhythms.

The reviews reported poor clarity around optimal BLT, as studies

applied heterogenous dosages and frequencies. The reviews concurred

“inconclusive” evidence for BLT. These reviews did not examine other

NPIs, thus BLT efficacy in comparison to other NPIs was unclear.

Livingston and colleagues (2005) and Brown and colleagues (2011)

reviewed NPIs. Reportedly, there was insufficient evidence for passive

body heating (e.g. taking a warm bath;), physical and social exercise (e.g.

personalised exercise plan) and “other behavioural interventions” (e.g.

Good Sleep Hygiene guidance; Livingston et al., 2005; Brown et al.,

2013). There was preliminary evidence for a multi-component intervention

(Nighttime Insomnia Treatment and Education for Alzheimer’s Disease;

NITE-AD) incorporating BLT, activity and CBT (Brown et al., 2013). These

reviews reported a lack of conviction in results due to poor methodological

quality of studies. However, neither review restricted inclusion of studies to

those with high-quality methodologies (e.g. randomised controlled trials;

RCTs).

The lack in high-quality research and conclusive findings has led to

an absence of clear guidance on NPIs for SDi in dementia. All 4 reviews

concluded more high-quality research into NPIs for SDi in dementia was

needed. Further, the Public Health Advisory Committee officially invited

“quality research” into interventions for SDi in dementia (NICE, 2015).

The current review

This systematic review aims to consolidate and compare efficacy

findings from high-quality trials conducted in the treatment of SDi in

dementia. It differs from previous reviews as it aims to restrict included

studies to those with “quality” methodologies (contrary to Livingston et al.,

2005; Brown et al., 2013). As such, it is based only the strongest results

available across the literature. Secondly, it aims to explore and compare

all researched treatments administrable by anyone with no medical

training (e.g. caregivers; assistant psychologists), without limitations. It

includes the spectrum of NPIs rather than just BLT (as in Forbes et al.,

2009 & 2014, those administrable by caregivers (as in Brown et al., 2011)

or those conforming to a particular model (e.g. psychosocial). As such, it

aims to highlight any potentially effective intervention provided it has been

subjected to a clinical trial. It aims to compare the efficacy of high-quality

BLT studies with that of other treatments, which has not been done before.

Lastly, more research into NPIs treating SDi in dementia have been

conducted since the aforementioned reviews. However conflicting findings

from intervention studies are present, making it difficult to ascertain which,

if any, NPIs are worth implementing in clinical practice. In short, this

review provides an up-to-date consolidation of the most convicted trials of

non-medical treaments, generally, for SDi in dementia. Such a review has

not yet been conducted. Ultimately, this review aimed to inform clinical

guidance and highlight recommendations for future research. Accordingly,

NPI efficacy on SDi outcomes were extracted. It also aims to provide a

critique of methodologies and provide recommendations for future

research.

Method

Development of search criteria

Search criteria were developed by the researcher (MS), in collaboration

with 2 supervisors (clinical psychologists with expertise in dementia

research; PD & RG). Index terms associated with SDi, dementia, older

people, RCT methodology and NPIs were used, according to the literature

review aims (Table 3). Using the index terms, comprehensive lists of

synonyms, broader and narrower terms were developed using Medical

Subject Headings and this constituted the search criteria. Within index

categories, terms were linked using ‘OR’, and across index categories,

using ‘AND’, generating results containing at least one word from each

index category.

Table 3Literature review search terms

Intervention terms

"psychological" OR "affective" OR "Cognitive" OR "emotional" OR "mental" OR "psychiatric" OR "Psychogenic" OR "Psychosocial" OR "psychosomatic" OR "rehabilitation" OR "Therap*" OR "Mindfulness" OR "relaxation" OR "MUSCLE RELAXATION" OR "RELAXATION THER*" OR "Relaxation Technics" OR "Relaxation Techniques" OR "Therapy, Relaxation" OR "Behavior*" OR "Behaviour*" OR "Placebo" OR "Spiritual" OR "Progressive Muscle Relaxation" OR "Progressive Relaxation" OR "Autogenic Training" OR "Bright Light" OR "Light therapy" OR "Light Therapy" Or "Photoradiation Therapy" OR "Therapy, Photoradiation" OR "Exercise" OR "physical" OR "Rehabilitation Exercise" OR "Remedial Exercise" OR "Therapy, Exercise" OR "Acute Exercise" OR "Aerobic Exercise" OR "Exercise Training" OR "Exercise, Aerobic" OR "Exercise, Isometric" OR "Exercise, Physical" OR "Isometric Exercise" OR "Physical Activity" OR "Exercise Movement Techniques" OR "Exercise Therapy" OR "Physical Exertion" OR "Physical Fitness" OR "Sports" OR "motor activity" OR "Hyperkinesis" OR "Psychomotor Performance" OR "Exercise" OR "Exertion" OR "Walking" OR "Sleep hygiene" OR "Good Sleep Habits" OR "Stimulus control" OR "Sleep Restriction" OR "Paradoxical intention" OR "Cognitive Behavioural Therapy" OR " Behavior Therapy, Cognitive" OR "Cognition Therapy" OR "Cognitive Behavior Therapy" OR "Cognitive Behavioral Therapy" OR "Cognitive Psychotherapy" OR "Psychotherapy, Cognitive" OR "Therapy, Cognition" OR "Therapy, Cognitive" OR "Therapy, Cognitive Behavior" OR "Biofeedback" OR "Biofeedback" OR "Biofeedback (Psychology)" OR "Bogus Physiological Feedback" OR "False Physiological Feedback" OR "Feedback, Psychophysiologic" OR "Feedback, Psychophysiological" OR "Myofeedback" OR "Psychophysiologic Feedback" Or "Feedback" OR "Heat Loss" OR "Regulation, Body Temperature" OR "Temperature Regulation, Body" OR "Thermoregulation" OR "BODY TEMPERATURE REG*"

Sleep terms

"Sleep" OR "Sleep Dis*" OR "Circadian" OR "Dyssomnia" OR "Hypersomnia" OR "Early Awakening" OR "Insomnia" OR "Nonorganic Insomnia" OR "Sleeplessness" OR "Parasomnia" OR "Sundowning"

Subject terms 1

"dementia" OR "SENILE" OR "PICK DISEASE" OR "PICK'S DISEASE" OR "Multi-Infarct" OR "Lacunar" OR "ALZHEIMER DIS*" OR "AD" OR "frontotemporal" OR "FTD" OR "FTLD" OR "Lewy Body" OR "Vascular"

Subject terms 2

"Elderly" OR "Pension*" OR "Aged" OR "Retire*" OR "Senior" OR "Elderly, Frail" OR "Frail Elders" OR "Elder" OR "Frail Older Adults" OR "Older Adult" OR "Older" OR "Old" OR "55+" OR "65+"

Study terms

"RCT" OR "randomised controlled trial" OR "Clinical Trials, Randomized" OR "Controlled Clinical Trials, Randomized" OR "Trials, Randomized Clinical" OR "Randomized Controlled Trial" OR "Clinical Trial" OR "randomised trial" OR "randomized trial" OR "Controlled Clinical Trial" OR "Naturalistic Randomized Clinical Trial" OR "Practical Clinical Trials" OR "pragmatic clinical Trials" OR "Pragmatic Trials" OR "Real World Clinical Trials" OR "Comparative Effectiveness Research"

Criteria for included studies

Articles reviewed were limited to those accessible, in English and

published in peer-reviewed journals (Table 4). No restrictions were placed

on date and location of publication, number of participants or setting of

studies.

RCTs are the “gold standard” methodology for evaluating treatment

efficacy (Meldrum, 2000). RCTs compare active treatments with control

treatments and reduce bias by controlling relevant parameters (e.g.

random sequence allocation reduces allocation bias). This review aimed to

explore “high-quality” research, therefore, studies included in this review

were restricted to those adopting an RCT design (Forbes et al., 2014).

Studies included PwD aged 55+ with a diagnosis of dementia (any

type). A dementia diagnosis based on a standardised clinical criterion (i.e.

NINCDS-ADRDA, DSM-IV, ICD-10; McKhann 1984; APA, 1995; WHO,

1992) or verified by a medical professional was required. If there were

mixed samples, at least 80% of participants had a diagnosis of dementia

and at least 80% of the PwD were over 55 years (Montgomery & Dennis,

2004).

Table 4Inclusion and exclusion criteria for trials examining NPIs for SDi in PwD.Inclusion Criteria Exclusion CriteriaAt least one baseline and follow-up outcome for assessing the extent of sleep disturbance

Only including interventions that must be overseen or administered by a medical doctor

Randomised Controlled Trial InaccessibleDiagnosis of dementia No English versionHuman participantsParticipants aged 55+At least one non-pharmacological intervention for SDiPublished in peer-reviewed journals

Included studies evaluated at least one NPI (not requiring

administration by a medical doctor). BLT studies were included, as they

have not been compared with other high-quality NPI studies in previous

reviews. Studies where an NPI was employed alongside pharmacological

treatment were included, provided there was a treatment condition where

an NPI was employed without the pharmacological intervention and

compared with a control condition. Active conditions incorporating

pharmacological treatments were omitted from this review, as it was not

possible to ascertain the impact of NPIs when combined. Studies including

participants with other clinical presentations (e.g. depression) were

included, provided they met all other inclusion and exclusion criteria. This

is likely to reduce ecological bias.

Selection of relevant studies

Databases queried on 21st October 2016 (all years) were: Web of

Knowledge and Pubmed/Medline. The Cochrane Collaborative Central

Register of Controlled Trials, was also reviewed. These databases were

selected as they are large hosts of social science, biomedical and

healthcare research citations. References from relevant reviews were

hand-searched and added to the list.

Searches were run on each database, and titles and abstracts

downloaded into Excel 2010. Titles were screened against inclusion and

exclusion criteria by MS. Studies clearly not meeting the criteria were

marked “ineligible”. If unclear or appearing to meet the inclusion criteria,

abstracts of articles were screened, and ineligible studies marked

correspondingly. Remaining articles were accessed and fully read; those

clearly ineligible or eligible were categorised accordingly. Papers

remaining unclear were discussed between MS and PD, who agreed on

inclusion.

Data extraction

Information to be extracted from the articles was decided in

collaboration between MS, PD and RG and based on systematic review

data commonly reported in the evidence base (Forbes et al., 2014).

Details pertaining to the study were extracted (e.g. setting of study, unit of

randomisation) as well as participant information (e.g severity of cognitive

impairment, type of dementia, diagnoses, demographic information,

medication controls) and Intervention outcome information (e.g.

type/format/duration/frequency of intervention/control conditions, outcome

and follow up data). Extracted data were organised using Excel 2010.

Critique of methodological quality

There are a number of tools available for assessing methodological

quality (e.g. Jadad) however The Cochrane Handbook for Systematic

Reviews of Interventions Risk of Bias (RoB) tool (CHSRI) was selected for

several reasons (Higgins et al., 2011). First, “methodological quality” is not

a concrete construct, thus, domains that contribute towards assessment

are debatable. The CHSRI has been repeatedly developed by a large

diversity of professionals, leading to greater refinement of important

contructs. Secondly, it is not a checklist- rather it focuses the researcher

on specific domains, meaning it can be adapted to a range of differing

methodolgies. Lastly, it considers both the conduct and reporting of

studies as factors that contribute to RoB.

The CHSRI highlights 6 categories of potential bias (Table 5). RoB

was analysed for each article by MS and organised using Microsoft Excel

2010. Missing information from articles was sought from authors by email.

If further information was unavailable the criterion was rated according to

available information. Once read, each criterion was rated “high-risk”,

“unclear-risk” or “low-risk” for each study. Ratings were quantified into a

score of “1”, “0.5” and “0” respectively. Individual studies were scored

between 0 and 6. Overall RoB scores below 2 indicated “high

methodological quality” (Pitkälä, Savikko, Poysti, Strandberg &

Laakkonen, 2013). Scores of 2-4 denoted “moderate methodological

quality” and scores above 4, “low methodological quality”.

Reporting guidelines

This review followed the Preferred Reporting Items for Systematic

Reviews and Meta-Analysis (PRISMA) guidelines (Moher, Liberati, Tetzlaff

& Altman, 2009).

Table 5The Cochrane Handbook for Systematic Reviews of Interventions tool (CHSRI) six categories of potential bias (from Higgins et al., 2011)

Bias domain Source of bias Support for judgment Review authors’ judgment (assessed as “low”, “unclear” or “high” risk of bias)

Selection bias

Random sequence generation

Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups

Selection bias (biased allocation to interventions) due to high-risk generation of a randomised sequence

Allocation concealment

Describe the method used to conceal the allocation sequence in sufficient detail to determine whether intervention allocations could have been foreseen before or during enrolment

Selection bias (biased allocation to interventions) due to high-risk concealment of allocations before assignment

Performance biasBlinding of participants and personnel*

Describe all measures used, if any, to blind trial participants and researchers from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective

Performance bias due to knowledge of the allocated interventions by participants and personnel during the study

Detection bias Blinding of outcome assessment*

Describe all measures used, if any, to blind outcome assessment from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective

Detection bias due to knowledge of the allocated interventions by outcome assessment

Attrition bias Incomplete outcome data*

Describe the completeness of outcome data for each main outcome, including attrition and exclusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomised participants), reasons for attrition or exclusions where reported, and any re-inclusions in analyses for the review

Attrition bias due to amount, nature, or handling of incomplete outcome data

Reporting bias Selective reporting State how selective outcome reporting was examined and what was found

Reporting bias due to selective outcome reporting

Other bias Anything else, ideally prespecified

State any important concerns about bias not covered in the other domains in the tool

Bias due to problems not covered elsewhere

*Assessments should be made for each main outcome or class of outcomes.

Records identified through database searching

(n = 178)

Sc re en in g

In clu de d

Eli gi bil

ity

Id en tifi ca tioAdditional records identified

through other sources(n = 7)

Records after duplicates removed(n = 174)

Records screened(n = 174)

Records excluded(n = 142)

Full-text articles assessed for eligibility

(n = 32)

Full-text articles excluded(n = 17)

Review article (n = 9)Protocol only (n = 1)Not an RCT (n = 1)

No sleep outcome measure (n = 3)

No NPI (n = 1)Unable to obtain paper (n = 1)Unable to ascertain number of people with dementia (n = 1)

Studies included in qualitative synthesis

(n = 14)

Two papers reported differing outcomes from

same study

Figure 1PRISMA diagram presenting the selection of included studies

Results

The search yielded 178 articles and 11 duplicates (Figure 1). Following

screening of titles and abstracts, 142 studies were ineligible. Querying

reference lists highlighted 7 additional articles which were added to the total.

One article could not be retrieved (Nowak, 2008). Overall, 32 full articles were

obtained and screened, and 17 were ineligible. Dowling, Mastick, Hubbard,

Lexenberg and Burr (2005) and (2007) reported on different outcomes, but

data was based on the same trial. Thus, findings from both articles were

merged for this review. Buettner and Fitzsimmons (2002) primarily recruited

participants with depression- despite this, it adhered to all inclusion and

exclusion criteria and was therefore included. Overall, 14 RCTs of NPIs for

SDi in dementia were included in this review (Table 6).

Overview of study characteristics and designs

All 14 studies adopted an RCT methodology but 3 used a cross-over

RCT design. Cross-over studies incorporated 1- (n=1) or 4-week (n=2) “wash-

out” periods during which participants disengaged from intervention and

control conditions, to reduce carryover bias. Nine studies evaluated NPIs in

care home facilities; 4 were trialled in the community. Twelve articles reported

one-to-one delivery of the NPI.

Table 6 Description of study characteristics of included articles

Authors Country of study

Setting of study Study design Unit of

randomisationFormat of

intervention Study approach to sleep medications

Ancoli-Israel et al., 2003 USA Care Home RCT PwD Individual No medications excluded but participants

medications notedBuettner & Fitzsimmons, 2002 USA Care Home RCT PwD Group No control for medications

Burns et al., 2009 UK Care Home RCT PwD Individual Changes in psychotropic medication were noted.

Chan et al., 2016 Hong Kong Community RCT PwD Group Participants on sleep medication excluded

Dowling et al., 2008 USA Care Home RCT Care Home: BLT;

(PwD: melatonin) Individual Participants regularly taking valerian root, melatonin or sleeping pill excluded

Dowling et al., 2005; 2007 USA Care Home RCT PwD Individual Participants regularly taking valerian root,

melatonin or sleeping pill excluded

Gasio et al., 2003 Switzerland Care Home RCT PwD Individual No excluded medication but Medication was kept “as constant as possible”

Lyketsos et al., 1999 USA Care Home Cross-over

RCT PwD Individual Medication kept stable for 1 week prior to enrolment and throughout study

McCurry et al., 2011 USA Community RCT PwD Individual Participants taking sleep medicines included

McCurry et al., 2005 USA Community RCT PwD Individual Participants taking sleep medicines included

Mishima et al., 1998 Japan Inpatient Cross-over

RCT PwD Individual Medication kept stable for 12 weeks prior to enrolment and throughout study

Richards et al., 2005 USA Care Home RCT PwD Individual

Clinicians asked to kept participants’ medication stable. Medication monitored for change weekly, changes discussed with a pharmacist (determined effect on sleep/wake patterns). If problematic, participation postponed until medication was.

Riemersma-van der Lek et al., 2008

Netherlands Care Home RCT Care Home Individual No medications excluded but participants medications noted

Sloane et al., 2015 USA Community Cross-over RCT PwD Individual

No medications excluded but participants medications noted at baseline and compared at the end of study participation

Articles reported on the efficacy of BLT, activity, mind-body and NITE-AD

(multi-component intervention combining BLT, activity and CBT) interventions in

ameliorating SDi in PwD (Table 7). McCurry and colleagues (2011) explored 3

NPIs within 1 study (i.e. BLT, activity, NITE-AD). Trials of activity and BLT were

administered heterogenously across studies. NITE-AD was administered identically

across 2 studies.

Participants

Seven studies used established dementia diagnostic criterion in selecting

participants (Ancoli-Israel et al., 2003; Burns et al., 2009; Dowling et al., 2009,

2005/2007; Lykestos et al., 1999; Mishima et al., 1998; Riemersma-van der Lek et

al., 2008). Eight confirmed dementia diagnosis with medical professionals (Gasio

et al., 2003; McCurry et al., 2005, 2011; Sloane et al., 2015; Chan et al., 2016;

Buettner & Fitzsimmons, 2002).

Five studies solely recruited participants with a diagnosis of AD, but overall,

PwD across studies had a variety of dementia diagnoses (AD, vascular dementia,

unspecified dementia, dementia with Lewy Bodies, multi-infarct dementia, alcohol-

and trauma-induced dementia). All studies tested PwD’s severity of cognitive

impairment using a cognitive screening tool. One study enrolled people with mild-

moderate dementia (Chan et al., 2016); 2 studies recruited people with moderate-

severe dementia (Gasio et al., 2003; Mishima et al., 1998); Lykestos and

colleagues (1999) did not report participants’ severity of cognitive impairment

(Table 8). The remaining 10 studies recruited participants with mild-severe

dementia.

Table 7Description of NPIs used in included articlesType of intervention

Authors Details of intervention Control condition Duration of intervention

Freq. of intervention

Ns in treatment

conditions1

Ns in control

condition1

BLT

Ancoli-Israel et al. 2003

1: Morning, 2hr BLT, 2,500 lux. 2: evening, 2hr BLT, 2,500 lux. (Both Fixed delivery)

Morning, 2hr dim red light, <300 lux. Fixed delivery. 10 days Daily 1: 30; 2: 31 31

Burns et al., 2009

Morning 2hr BLT 10,000 lux. Fixed delivery.

Morning, 2hr standard light, 100 lux. Fixed delivery. 2 weeks Daily 26 22

Dowling et al., 2009*

1: Morning 1hr BLT >2500 lux. Fixed delivery. Usual indoor light (150–200 lux). 10 weeks Monday-

Friday 18 17

Dowling, et al., 2005; 2007

1: Morning 1hr BLT >2500 lux; 2: Afternoon 1hr BLT >2500 lux. (Both fixed delivery)

Usual indoor light (150–200 lux) 10 weeks Monday-Friday 1: 29; 2: 24 17

Gasio et al., 2003

Morning and evening DDS with white lightbulb- max bright light=400 lux. Ambient delivery.

Morning and evening DDS with red lightbulb (<5 lux). Ambient delivery. 3 weeks Daily 9 4

Lyketsos et al., 1999

Morning 1hr BLT 10,000 lux. Fixed delivery.

Morning 1hr dim light (lux not reported). Fixed delivery. 4 weeks Daily 15 15

Mishima et al., 1998

Morning 2hr BLT (5000-8000 lux). Fixed delivery.

Morning 2hr dim light (300 lux). Fixed delivery. 2 weeks Daily 22 22

Riemersma-van der Lek et al., 2008*

Whole day BLT, 1000 lux. Ambient delivery.

Whole day dim (±300 lux) light and evening placebo melatonin

Mean(SD) of 15(12) months

(max: 3.5 years).

Daily 1: 49; 2: 46; 3: 49 45

McCurry et al., 20111

Evening 1hr BLT 2500 lux (fixed delivery)

Psychoeducational literature and advice on age- and dementia- related changes in sleep; information on sleep hygiene; information of local community support; available for advice.

2 months Daily 25 29

Sloane et al., 2015

Whole day 13,000K blue-white BLT (300-400 lux) ambient and fixed delivery.

Whole day 2700K red-yellow BLT (100 lux) ambient and fixed delivery.

6 weeks Daily 15 16

Act

ivity

Buettner & Fitzsimmons, 2002

Intense period: 15 min cycle on wheelchair bike and small group discussion. Maintenance period: 15 min cycle on wheelchair bike.

Not reported.

2-week intense period; 10-week

maintenance period

Intense period: 1hr 5

times per week;

maintenance period: 15 mins twice

weekly.

41 participants in total, number in each

condition not reported

Richards et al., 2005

Individualized social activities, selected based on interests, cognitive and functional abilities. E.g. listening to music

Treatment as usual 3 weeks

1-2 hrs in 15-30 min sessions

daily

71 68

McCurry et al., 20111 Activity (walking)


2 months Activity: 30 mins/day 27 29

Min

d-bo

dy

treat

men

t

Chan et al., 2016

TCQ practice sessions; participants also provided with an audio-visual DVD and pictures of the forms.

Encouraged to maintain routine activities, attended a weekly health talk- no sleep and physical activity information was discussed.

2 months

Group: 1hr twice a

week; daily practice

27 25

Mul

ti-co

mpo

nent

(CB

T-I,

Act

ivity

, BLT

)


NITE-AD (multi-component intervention combining CBT, activity and evening 1hr BLT 2500 lux (fixed delivery).


2 months

NITE-AD: Six 1-hr sessions

over 2 months

27 29


NITE-AD (multi-component intervention combining CBT, activity and evening 1hr BLT 2500 lux (fixed delivery).


2 monthsSix sessions

over 2 months

17 19

*Results from conditions excluded from literature review as treatment includes a pharmacological intervention; 1McCurry et al., 2011 investigated multi-component, BLT and Activity treatments within the same study. Each treatment was assessed against a control condition, as well as against each other; BLT: Bright Light Therapy; CBT-I: Cognitive Behavioural Therapy for Insomnia; TCQ: Tai Chi Qigong; DDS: Dawn Dusk Stimulation

Table 8Description of participant characteristics in included articles

Study number Participants' other diagnosesMMSE cut-off score

Participants' age range

Participants' Mean age

Overall %

women

Overall % white ethnicity

Severity of cognitive

impairmentAncoli-Israel et al., 2003 NR None 60-100 82.3 67.7 NR Mild- SevereBuettner & Fitzsimmons, 2002 All participants identified as having depression 24 NR NR NR NR Mild- SevereBurns et al., 2009 NR None NR 83.4 67.5 NR Mild- SevereChan et al., 2016 NR 13–26 60-97 80 85 NR Mild- Moderate

Dowling et al., 2011 Participants with other neurological diagnoses and Parkinson’s disease excluded None 60-100 86 86 NR Mild-Severe

Dowling et al., 2005; 2007 Participants with other neurological diagnoses and Parkinson’s disease excluded None 58-98 84 81.4 NR Mild-Severe

Gasio et al., 2003 Patients with other medical illness excluded None 80-90 85 92 NR Moderate-Severe

Lyketsos et al., 1999Participants with major depressive episode, delusions, hallucinations, and "manic syndrome" excluded

NR NR 80.8 93.3 100 NR


Participants with a previous diagnosis of sleep apnoea, restless legs, periodic leg movements syndromes or rapid eye movement sleep behaviour disorder excluded

NR NR 81 55.25 86 Mild-Severe


Participants with a previous diagnosis of sleep apnoea, restless legs, periodic leg movements syndromes or rapid eye movement sleep behaviour disorder excluded

NR 63-93 77.7 44 92 Mild- Severe

Mishima et al., 1998 NR NR NR 79.5 59.1 NR Moderate-Severe

Richards et al., 2005 NR 24 55-NR 79 48.2 NR Mild- SevereRiemersma-van der Lek et al., 2008 NR None None-None 85.8 years 89.9 NR Mild- Severe

Sloane et al., 2015 NR 25 65-NR 65% over age 80 65 82 Mild- SevereNR= Not reported; MMSE= Mini-Mental State Examination

Sleep outcomes

Sleep outcomes, and the times trials collected them, varied across

studies (Table 9). Several studies used multiple sleep outcomes and no one

sleep parameter was consistent across all trials, however, night-time sleep

duration was reported by most studies (n=12). Actigraphy, quantitative

outcome measures, daily sleep charts and qualitative perspectives were used

to gather sleep outcome data across studies (Table 10).

Effects of interventions on quantitative sleep outcomes

Trials reported efficacy findings of BLT, activity, NITE-AD and mind-

body treatments (MBTs) on various parameters of SDi (Table 11). Reported

efficacy findings were restricted to those significant when compared with a

control group (p<0.05).

BLT

Four of 10 studies investigating BLT reported at least 1 significant

difference in a SDi parameter immediately post-intervention (Ancoli-Israel et

al., 2003; Lyketsos et al., 1999; McCurry et al., 2011; Mishima et al., 1998).

However, delivery of BLT and changed sleep parameters varied across

studies: McCurry and colleagues (2011) and Mishima and colleagues (1998)

found that BLT significantly reduced night-time wakefulness (p=0.04; p<0.05)

although the delivery time, lux and duration of BLT differed. Ancoli-Israel and

colleagues (2003) reported improvements in night-time sleep bout duration

(p=0.02), however, this is a different construct to night-time sleep duration as

it refers to the duration of sleep before wakefulness, rather than night-time

wakefulness duration overall.

Table 9Summary of sleep quality outcome measurements collected by each studyAuthors Outcome assessment interval Sleep Outcome measures reported

Ancoli-Israel et al., 2003

Actigraphy: Continuously for three days at baseline, 10 days (grouped into days 1-5 and days 6-10) during intervention and 5 days immediately post intervention.

Actigraphy: day and night total sleep duration, bedtime, wake time, percentage of time spent awake, percentage of time spent asleep, wake after sleep onset (hours), duration of sleep bouts.

Dowling et al., 2011

Actigraphy: 108 hours over five nights, four days at baseline and 108 hours over five nights, four days immediately post intervention (Mon 8:00pm-Sat 8:00am)

Actigraphy: night-time bedtime, wake time, average number of night-time sleep bouts, average number of night-time wake bouts, average duration of night-time sleep bouts, duration of night-time sleep bouts; daytime sleep duration, number of daytime sleep bouts, daytime total activity score, day/night sleep ratio.

Dowling et al., 2005; 2007

Actigraphy: Continuously for 6 days, 7 nights at baseline; continuously for 4 days, 5 nights immediately post intervention.

Actigraphy: Sleep efficiency, sleep time, wake time, number of night-time awakenings, duration of night-time awakenings, mean night and day activity levels, daytime wake duration.

Mishima et al., 1998 Actigraphy: Continuously for two weeks during intervention. Actigraphy: night-time wake duration, average night-time activity and

percentage of night-time activity to average daily total activity.

Richards et al., 2005

Actigraphy: Continuously for 5 days at baseline, continuously for 5 days immediately post intervention.

Actigraphy: daytime sleep duration, night-time sleep onset latency, night-time sleep duration, night-time awake duration, night-time sleep efficiency (percentage of time in bed asleep), day:night sleep ratio.


Actigraphy: Mean(SDi) of 14(4) days per participant during intervention at 6 weeks, 6 months, 1 year, 1.5 years and 2 years.

Actigraphy: night-time sleep efficiency (percentage of time asleep while in bed), night-time sleep duration, night-time sleep onset latency, night-time restlessness (minutes per hour), duration of night-time awakenings, duration of uninterrupted sleep.

Sloane et al., 2015

Actigraphy: Continuously for one week at baseline, during study (week 2) and immediately post intervention.Semi-Structured Assessment Measures: Pittsburgh Sleep Quality Index, MOS and ESS at baseline and immediately post intervention.

Actigraphy: night-time sleep duration, night-time sleep onset latency, night-time sleep efficiency, number of sleep bouts.Semi-Structured Assessment Measures: Pittsburgh Sleep Quality Index: Sleep efficiency, sleep quality index. MOS: Sleep adequacy, sleep problems, sleep disturbance, sleep index, sleep somnolence. ESS: total index.


Actigraphy: Continuously for 7 days at baseline, immediately post intervention and follow up (6 months).Sleep charts: Daily. Frequency and period of recording not reported.

Actigraphy: Nocturnal sleep duration, night-time awake duration, number of night-time awakenings, duration of night-time awakenings, percentage of night-time asleep, night-time wakes/hour, duration in bed.Sleep charts: Bedtime and rising time.


Actigraphy: Continuously for 7 days at baseline, immediately post-intervention (2 months) and follow up (6 months).Sleep charts: Daily. Frequency and period of recording not

Actigraphy: Nocturnal sleep duration, night-time awake duration, number of night-time awakenings, duration of night-time awakenings, percentage of night-time asleep, night-time wakes/hour, duration in bed, daytime sleep.

reportedSemi-Structured Assessment Measures: ESS at baseline and immediately post intervention and follow up.Qualitative measures: Caregivers contacted after the 6-month follow-up (method not clear).

Sleep charts: Bedtime and rising timeSemi-Structured Assessment Measures: ESS: total index.Qualitative measures: Satisfaction of the intervention.

Burns et al., 2009

Actigraphy: Continuously for 24 hours at baseline, post intervention (4 weeks) and follow up (8 weeks).Sleep charts: At 30 min intervals throughout intervention.

Actigraphy: Nocturnal sleep duration.Sleep charts: Nocturnal sleep duration.

Gasio et al., 2003

Actigraphy: Continuously for 7 days at baseline, throughout intervention and immediately post intervention.Sleep charts: daily, frequency of data collection not reported.

Actigraphy: Time in bed, sleep onset time, sleep end time, assumed sleep duration, actual sleep duration, sleep efficiency, sleep latency, number of wake bouts, number of immobile phases, mean activity counts during sleep. Light exposure.Sleep charts: daily times of going to bed and getting up.

Buettner & Fitzsimmons, 2002

Sleep charts: Daily, frequency of data collection not reported. Reviews at baseline, 2 weeks (post intense period) and 10 weeks (post maintenance period).

Sleep charts: Number of night-time awakenings, number of sleep interventions.

Lyketsos et al., 1999

Sleep charts: Kept between 8pm and 8am at baseline, during study (2 weeks) and post-intervention (4 weeks). Frequency of recording not reported.

Sleep charts: Mean night-time sleep duration in the past week.

Chan et al., 2016

Semi-Structured Assessment Measure: Chinese Pittsburgh Sleep Quality Index at baseline, post-intervention (2 months), and follow-up (6 months).

Semi-Structured Assessment Measure: Chinese Pittsburgh Sleep Quality Index: Global sleep quality, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medication, daytime dysfunction.

Pittsburgh Sleep Quality Index: Pittsburgh Sleep Quality Index; Chinese Pittsburgh Sleep Quality Index: Chinese Pittsburgh Sleep Quality Index; ESS: Epworth Sleepiness Scale; MOS: Medical Outcomes Study sleep measures

Table 10Description of sleep quality outcome measurements used by each studySleep outcome measure Description

ActigraphyActiwatches are small devices worn around the wrist, that detect movement. Actiwatches can hold large volumes of intricate, objective, digital readings. Sleep-wake information is inferred from a “count” of movement during a predefined interval (e.g. 1-minute). This technology allows for analysis of vast behavioural data. Also, it reduces the need for human monitoring.

Pittsburgh Sleep Quality Index (Buysse, Reynolds, Monk, Berman & Kupfer, 1989).

This self-report questionnaire comprises 4 open-ended and 13 frequency-based questions and a rating of overall subjective sleep quality. Summated, produces the sleep index composite score. This index incorporates 7 sub-scales, however only one subscale (sleep efficiency) was reported by 1 study. The Pittsburgh Sleep Quality Index has good internal consistency (Cronbach’s α=0.83) and test–retest reliability (Cronbach’s α=0.87; Carpenter & Andrykowski, 1998; Backhaus et al., 2002). The clinical cut-off score of 5 (sleep index composite score) has high sensitivity and specificity in adults (Buysse, Reynolds, Monk, Berman & Kupfer, 1989).

Chinese Pittsburgh Sleep Quality Index (Tsai et al., 2005)

Translated version of the Pittsburgh Sleep Quality Index. The Chinese Pittsburgh Sleep Quality Index has good reliability (Cronbach’s α=0.82 –0.83), acceptable test–retest reliability (Cronbach’s α=0.77) and a sensitivity and specificity of 98% and 55% respectively (cut-off score of 5; Tsai et al., 2005).

The Medical Outcomes Study sleep measure was used in 1 study (Hays & Stewart, 1992)

Sleep index score was produced through 12 self-report sleep questions. Sleep adequacy, sleep problems, sleep disturbance and sleep somnolence subscales were also reported. Internal consistency and reliability estimate for the general sleep index of the Medical Outcomes Study were good (Chronbach’s α= 0.83-0.78). Cronbach alpha ranged from 0.75 to 0.86 for subscales. Within-subscale item correlations varied considerably (0.03–0.64) and subscale inter-correlations ranged from 0.05 to 0.88.

Epworth Sleepiness Scale (Johns, 1991)

8-question self-report questionnaire in which likelihood of falling asleep in 8 daily life situations is rated. An index score (summation of responses) was reported by both studies. A cut-off score of 10 indicated significant excessive daytime sleepiness. Internal consistency for the Epworth Sleepiness Scale is acceptable (Chronbach’s α= 0.70). However, psychometrics data are otherwise lacking.

Daily sleep charts

Kept by nurses (Burns et al., 2009; Gasio et al., 2003) or caregivers (McCurry et al., 2011; McCurry et al., 2005). The keeper of the sleep chart was not reported by Buettner & Fitzsimmons (2002). Sleep charts were used to supplement actigraphy (McCurry et al., 2011; McCurry et al., 2005; Burns et al., 2009; Gasio et al., 2003) or as the primary measure (Buettner & Fitzsimmons, 2002; Lyketsos et al., 1999). Studies varied slightly with regards to what they were measuring.

Qualitative data

McCurry and colleagues (2005) requested qualitative information from caregivers to assess satisfaction with multi-component (i.e. NITE-AD), activity and BLT interventions following engagement (i.e. how the intervention helped them understand and manage the person with dementia's sleep and how burdensome they found it). Satisfaction for NITE-AD was highest, although high levels of satisfaction was also reported for activity and BLT interventions.

Table 11Summary of significant post intervention and longitudinal findings on sleep quality outcomes, as a result of sleep interventions

Study NumberType of

Intervention

Summary of significant findings1 Longitudinal follow-up sleep outcomes1

Ancoli-Israel et al., 2003 BLT

Morning BLT: Significant increase in night-time sleep bout duration (p=0.05)

Evening BLT: Significant increase in night-time sleep bout duration (p=0.02)

No follow up

Lyketsos et al., 1999 BLT Morning BLT: significant increase in night-time sleep duration between

baseline and 4 weeks (p<0.05). No follow up

McCurry et al., 2011 BLT Evening BLT: Significantly reduced night-time wakefulness (p=0.04) No significant changes reported.

Mishima et al., 1998 BLT

Morning BLT: Significant reduction in night-time wakefulness (p<0.05) and ratio of night-time wakefulness to total awake time (p < 0.05) in

people with VD.No Follow up

Gasio et al., 2003 BLT DDS: No significant findings reported No significant changes reported.


BLT Whole day bright light: No significant findings reported No Follow up

Dowling et al., 2005; 2007 BLT Morning BLT: No significant findings reported

Afternoon BLT: No significant findings reported No follow up

Burns et al., 2009 BLT Morning BLT: No significant findings reported. No significant changes reported.

Dowling et al., 2011 BLT Morning BLT: No significant findings reported. No follow up

Sloane et al., 2015 BLT Whole day BLT: No significant findings reported. No Follow up

Buettner & Fitzsimmons, Activity Cycling activity: No significant findings reported. Cycling activity: No significant findings reported.

2002

McCurry et al., 2011 Activity Walking: Significantly shorter night-time awake duration (p=0.04). No significant changes reported.

Richards et al., 2005 Activity

Individualised activity: Significant reduction in daytime sleep duration (p=0.001), significant reduction in day:night sleep ratio (p=0.03).

Secondary analysis: significant reduction in daytime sleep duration (p=0.005), significantly reduction in day:night sleep ratio (p=0.02), significantly shorter night-time sleep latency (p=0.03), significant

reduction in night-time wake duration (p=0.04).

No Follow up

Chan et al., 2016 MBT (TCQ) TCQ: No significant findings reported.TCQ: Significantly improved subjective sleep quality (p=0.004),

significantly increased night-time sleep duration (p=0.003), significantly increased sleep efficiency (p=0.002).


Multi-component

NITE-AD (CBT+activity+ Evening BLT): significant reduction in night-time awake duration (p=0.05).

Morning BLT+CBT+activity: significant reduction innight-time wake duration (p=0.03), significant reduction in number of night-time awakenings (p=0.01), significant reduction in night-time wakes per hour (p=0.03), significant reduction in duration of

night-time awakenings (p=0.04) compared with control group.McCurry et al., 2011

Multi-component

NITE-AD (CBT+activity+ Evening BLT): Significantly shorter night-time awake duration (p=0.01).

No significant changes maintained. No additional significant changes reported.

1Quantitative findings reported in this review are restricted to those pertaining to a non-pharmacological intervention, and significant when compared with a control group (p≤0.05). BLT: Bright Light Therapy; CBT-I: Cognitive Behavioural Therapy for Insomnia; MBT: Mind-body Treatment; TCQ: Tai Chi Qigong; DDS: Dawn Dusk Stimulation.

Mishima and colleagues (1998) reported reductions in the ratio of

night-time awakenings compared with total awake time in people with

vascular dementia (p<0.05). However, 6 studies reported no immediate

effects of BLT. Longitudinal data were collected by 3 BLT studies and showed

no significant long-term benefits.

Activity

Three studies explored activity interventions, however, 2 reported

significant changes in at least 1 sleep parameter. Reportedly, individualised

social activities reduced daytime sleep duration (p=0.001) and improved

day:night sleep ratios (p=0.03; Richards et al., 2005). Secondary analysis

(including residents with “<50% sleep efficiency” at baseline) revealed

significant reductions in night-time sleep onset latency (p=0.03), night-time

wakefulness duration (p=0.04), daytime sleep duration (p=0.005) and

improved day:night sleep ratio (p=0.02). McCurry and colleagues (2011)

reported reduced night-time wakefulness (p=0.04), which was not maintained

at 6-month follow-up.

Tai Chi Qigong

Chan and colleagues (2016) investigated “Tai Chi Qigong” (TCQ), a

mind-body treatment. There were no significant benefits immediately post-

intervention. However, at 6-months follow-up, findings showed significant

improvements in overall sleep quality (p=0.004), night-time sleep duration

(p=0.004) and sleep efficiency (p=0.002).

NITE-AD

McCurry and colleagues (2005; 2011) investigated identical multi-

component interventions (NITE-AD, comprising CBT, activity and BLT). Both

studies observed significant reductions in night-time wakefulness immediately

post-intervention (p=0.01). However, the improvement was maintained at 6-

month follow-up only in the later study (p=0.03). Additionally, at 6-month

follow-up, the latter study reported significant reductions in number of night-

time awakenings (p=0.01) and duration of night-time awakenings (p=0.04).

Risk of bias (RoB)

RoB assessment was informed by the CHSRI (Table 5; Higgins et al.,

2011). Accordingly, risk of Selection, Performance, Detection, Attrition,

Reporting and “Other” Biases were assessed. Each study was rated “high-

risk”, “unclear-risk” and “low-risk” for each construct (Table 12). Data

contributing to RoB assessment were based on descriptions from articles and

supplemented with additional information from Forbes and colleagues (2014),

as they contacted authors and published supplementary information for their

review. No authors responded to the researcher’s emails requesting additional

information.

Table 12Summary of risk of bias data using the Cochrane Handbook for Systematic Reviews of Interventions tool (version 5.1.0; Higgins et al., 2011)Type of intervention Authors Selection

Bias Performance bias Detection Bias Attrition bias Reporting bias Other Bias Overall risk of bias score

BLT

Ancoli-Israel et al., 2003 Low-risk Unclear-risk1 Unclear-risk High-risk Low-risk High-risk 3Burns et al., 2009 Low-risk High-risk High-risk Low-risk High-risk Unclear-risk 3.5Dowling et al., 2005; 2007 Low-risk High-risk Low-risk High-risk Low-risk High-risk 3Dowling et al., 2011 Low-risk High-risk High-risk High-risk Low-risk Unclear-risk 3.5Gasio et al., 2003 Low-risk1 Low-risk1 High-risk High-risk High-risk Unclear-risk 3.5

Lyketsos et al., 1999 High-risk1 High-risk1 Low-risk Low-risk Low-risk High-risk 3Mishima et al., 1998 High-risk High-risk Low-risk High-risk High-risk Unclear-risk 4.5Riemersma-van der Lek et al., 2008 Low-risk Low-risk Low-risk Unclear-risk Low-risk High-risk 1.5

McCurry et al., 20112 Low-risk High-risk Low-risk Low-risk Low-risk High-risk 2Sloane et al., 2015 High-risk High-risk High-risk High-risk Low-risk High-risk 5

ActivityBuettner & Fitzsimmons, 2002 High-risk High-risk High-risk High-risk Low-risk High-risk 5Richards et al., 2005 High-risk High-risk Low-risk High-risk Unclear-risk Low-risk 3.5McCurry et al., 20112 Low-risk High-risk Low-risk Low-risk Low-risk High-risk 2

Mind-body treatment Chan et al., 2016 Low-risk1 High-risk1 High-risk1 Low-risk Low-risk Low-risk 2

Multi-component (NITE-AD)

McCurry et al., 20112 Low-risk High-risk Low-risk Low-risk Low-risk High-risk 2

McCurry et al., 2005 High-risk High-risk Low-risk Unclear-risk High-risk High-risk 4.51Data supplemented and extracted from Forbes et al., 2014; 2McCurry et al., 2011 presented findings on BLT, Activity and multi-component interventions. Overall risk of bias scores <2=high methodological quality; scores 2-4=moderate methodological quality; and scores >4=low methodological quality.

Selection Bias

Selection Bias was assessed by considering the strategies used to perform

randomisation and conceal allocation by studies. A variety of randomisation methods,

which provided adequately random and concealed groups, was used (e.g. random

number lists). However, 5 trials provided insufficient information regarding

randomisation processes (BLT: Lykestos et al., 1999, Sloane et al., 2015, Mishima et

al., 1998; Activity: Buettner & Fitzsimmons, 2002, Richards et al., 2005). These trials,

and one other of NITE-AD (McCurry, 2005), did not adequately disclose the process

allocation concealment. Overall, there was a “high-risk” of Selection Bias in 3 studies of

BLT (Lykestos et al., 1999; Mishima et al., 1998; Sloane et al., 2015), 2 studies of

activity (Buettner & Fitzsimmons, 2002; Richards et al., 2005) and 1 study of NITE-AD

(McCurry et al., 2005).

Performance Bias

Performance bias is concerned with strategies used to blind study participants

and personnel delivering treatments. Two studies of BLT (Gasio et al., 2003;

Riemersma-van der Lek et al., 2008) reported adequate blinding of participants and

study personnel. Ancoli-Israel and colleagues (2003) told participants and study

personnel that both active and control intervention may be efficacious, to reduce

Performance Bias. This was considered an “unclear-risk”. Otherwise, studies reported

an inability to blind participants and study personnel, suggesting widespread “high-risk”

of Performance Bias (BLT: Burns et al., 2009, Dowling et al., 2005; 2007, Dowling et al.,

2011; Activity: Buettner & Fitzsimmons, 2002, Richards et al., 2005; Mind-body: Chan et

al., 2016; NITE-AD: McCurry et al., 2005; BLT/activity/NITE-AD: McCurry et al., 2011).

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Detection Bias

Detection Bias may be introduced if knowledge of allocation is held by study

personnel assessing outcomes. Eight studies reported adequate blinding of outcome

assessors. Ancoli-Israel and colleagues (2003) reported that outcome assessors could

not be kept blind but were told that both the active and control intervention may be

efficacious; this was considered an “unclear-risk”. Detection Bias was rated “high-risk”

for 2 trials of BLT (Burns et al., 2009; Sloane et al., 2015), one activity trial (Buettner &

Fitzsimmons, 2002) and the mind-body trial (Chan et al., 2016).

Attrition Bias

This review explored trials’ dropout rates, reported reasons for drop-outs,

employment of intention-to-treat analysis and management of missing data in assessing

Attrition Bias. Participant attrition is largely unavoidable in clinical research. Research

suggests drop-out rates below 20% indicate “low-risk” of bias (Birks & Harvey, 2006).

Drop-out rates were “low-risk” in half of the studies, overall. However, Ancoli-Israel and

colleagues (2003) reported a 21% drop-out rate, Gasio and colleagues a 35% dropout

rate and Lykestos and colleagues (1999) a 47% drop-out rate in studies of BLT. Chan

and colleagues also reported a 27% drop-out rate from their mind-body study. Three

studies did not report drop-out rates or reasons for drop-outs (BLT: Mishima et al.,

1998, Dowling et al., 2005; 2007; activity: Buettner & Fitzsimmons, 2002). Reasons for

drop-outs were incomplete in one study of NITE-AD (McCurry, 2005). Otherwise, 10

studies adequately reported on reasons for participant drop-outs.

Half the studies reportedly adopted an intention-to-treat approach to data

analysis (McCurry et al., 2005, 2011; Chan et al., 2016; Lyketsos et al., 1999;

38

Riemersma-van der Lek et al., 2008; Ancoli-Israel et al., 2003; Burns et al., 2009) and

half did not. Five articles reported adequate efforts to manage missing data: Burns and

colleagues (2009) conducted interviews with drop-outs; Chan and colleagues (2016)

used Generalised Estimating Equation modelling; Lyketsos and colleagues (1999) used

a Last Observation Carried Forward approach; and McCurry and colleagues (2005)

carried baseline values forwards, but employed a General Linear Model In their later

study (2011). Richards and colleagues (2005) presented an "unclear-risk" in that, where

there was missing sleep diary data, they substituted with “less-accurate” Actigraph

software estimations. Overall, 8 BLT trials presented a “high-risk” of Attrition Bias (BLT:

Ancoli-Israel et al., 2003; Dowling et al., 2005/2007, 2011; Gasio et al., 2003; Mishima

et al., 1998; Sloane et al., 2015; Activity: Buettner & Fitzsimmons, 2002; Richards et al.,

2005).

Reporting bias

Studies were expected to report on outcome measures proposed in their

Methods sections, however, the analysis of Reporting Bias was restricted to sleep

outcomes in this review. Ten trials adequately reported on proposed sleep outcomes,

however, 4 neglected to report 1 or more expected outcomes, and considered to have

“high-risk” of Reporting bias. Burns and colleagues (2009; BLT) did not explicitly report

8-week post-treatment nocturnal sleep duration. T- or p-values were not reported for

any nonsignificant results in Gasio and colleagues’ study (2003; BLT). Mishima and

colleagues (1998; BLT) neglected to report on average daytime activity, despite

percentage of night-time activity to average daytime activity being a primary outcome.

McCurry and colleagues (2005; NITE-AD) mentioned calculating rest-activity cycles but

39

did not report them. One study conducted secondary analyses not stipulated in the

Method (Richards et al., 2005). Although well justified, the activity trial reported non-pre-

specified outcomes, and therefore an “unclear-risk” of Reporting Bias was concluded.

Other bias

There was a variety of other biases present in 5 studies. Four BLT studies that

employed actigraphy did not report on actigraphy compliance, meaning there may have

been a lack of transparency about missing data (Burns et al., 2009; Sloane et al., 2014;

Mishima et al., 1998; Gasio et al., 2003). It is not possible to definitively monitor bed and

wake time outcomes using actigraphy, however Dowling and colleagues (2005; 2007),

Ancoli-Israel and colleagues (2003) and Richards and colleagues (2005) used

potentially inaccurate actigraphy estimates, which may have skewed outcomes. Dowling

and colleagues (2011) reported the amount of BLT received varied from 40%-97%

across participants and it was unclear whether there were between group differences.

Another reported between-group differences at baseline, but it was unclear how these

were controlled for in the analysis (Ancoli-Israel et al., 2003). Also, the nature of the

control group was not reported, and it was unclear which sub-sample of participants

were included in the analysis of SDi. All participants in Buettner & Fitzsimmons’ (2002)

activity study had significant depression and how this impacted on SDi and the

intervention uptake was unclear.

40

Selection Bias

Performance bias

Detection Bias

Attrition bias

Reporting bias

Other Bias

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

8

2

6

5

9

2

0

1

3

1

1

4

6

11

5

8

4

8

Low-riskUnclear-riskHigh-risk

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Figure 2Methodological quality graph summarising the researcher’s ratings of each methodological quality item presented as percentages across studies.

Summary of methodological quality

This review aimed to assess high-quality research. Overall RoB in each study

was based upon 6 criteria each rated “high-risk”, “unclear-risk” or “low-risk”. The ratings

were quantified into a score of “1”, “0.5” and “0” respectively, composing an overall RoB

score between 0 and 6. One study of BLT scored below 2 meaning it was of “high

methodological quality”. However, 9 studies scored between 2 and 4 and were therefore

of “moderate methodological quality”. Four studies scored over 4, and were of “low

methodological quality”. Across articles, risk of Reporting Bias was lowest, followed by

Selection Bias (Figure 2). However, studies most frequently had high risk of

Performance bias, followed by Attrition and Other bias.

Discussion

Dementia prevalence is rising, and dementia-related care poses a significant

challenge for PwD, caregivers and healthcare services. SDi is a widespread, debilitating

BPSD, causing increased caregiver burden leading to early institutionalisation, inceased

SDi and psychological, behavioural and cognitive decline. Medications have detrimental

side effects and there is no evidence base for their long-term use, so, NPIs to treat SDi

in dementia are being explored. Previous reviews concluded that findings into

researched NPIs (e.g. activity) are inconclusive due to poor methodological quality and

heterogeneity of treatments across studies (Forbes et al., 2009; 2014; Deschenes &

McCurry, 2009; Brown et al., 2013). Consequently, there is a lack of clear clinical

guidance on the treatment of SDi in dementia, thus, NICE called for “quality research” in

this area (NICE, 2015).

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This review included 14 RCTs of BLT, activity, mind-body and NITE-AD

treatments. This review aimed to synthesise and compare findings from RCTs,

providing an up-to-date review of the efficacy of NPIs for SDi in dementia. It also aimed

to critique the studies, informed by RoB analysis, to ascertain the completeness and

applicability of studies.

Synthesis of NPI efficacy results and clinical implications

BLT

Four of ten RCTs of BLT reported significant improvements in SDi following

treatment. Where significant results were reported, associated sleep parameters varied

across studies. This inconsistency may have been due to the heterogeneity in BLT

delivery or outcome measures used across studies. However, as previous reviews

suggest, it may also be because significant findings are unreliable (Forbes et al., 2014).

Interestingly, 1 study found morning BLT benefitted people with VD more than those

with AD, supporting the notion that the neuropathology and treatment of SDi across

dementia subtypes may differ (Zhao et al., 2016). There was no long-term benefits of

BLT, suggesting continued application of daily BLT would be needed for benefits to be

sustained. One study reported BLT compliance varied between 40% and 97%,

suggesting sufficient BLT may be challenging to dispense to some PwD. It was unclear

how the varying dosages, methods of delivery and time of BLT used by studies may

have impacted the efficacy of BLT, meaning it remains unclear how to best administer

BLT in clinical practice. There appeared to be no obvious links between BLT trials that

yielded significant results and those that did not. All 4 studies reporting significant

43

changes in SDi were of moderate methodological quality, suggesting RoB may have

impacted efficacy results. Further, there were several insignificant results, including that

of a trial with high methodological quality.

These findings were consistent with previous reviews and compound

suggestions that BLT may be ineffective at alleviating SDi in dementia (Forbes et al.,

2014). There remains insufficient evidence for BLT in treating SDi in dementia.

Activity

In PwD, exercise can improve strength and muscle mass, leading to reductions

in falls and improved confidence (Pitkälä, Savikko, Poysti, Strandberg & Laakkonen,

2013). Further, individualised activities may reduce behaviours that challenge and

improve quality of life in PwD (Möhler, Renom, Renom & Meyer, 2018). Therefore,

reported findings that walking and individualised activity programmes improved SDi

were exciting. There was no evidence for the long-term benefits of the walking

programme suggesting its uptake was not maintained or the benefits staved off. Trials

of activity had overall RoB scores between 4 and 5, suggesting results were affected by

multiple constructs of bias. Therefore, there remains a paucity of high-quality evidence

for activity interventions, meaning it is too early to make claims about whether activity

can ameliorate SDi in dementia. Activity interventions appear to provide holistic benefits

and may improve SDi, and therefore, are likely to be more beneficial, generally, than

BLT.

Tai Chi Qigong (TCQ)

One study employed TCQ, a novel approach to ameliorating SDi in dementia.

MBTs such as TCQ incorporate various practices (e.g. breathing exercises) designed to

44

enhance holistic well-being (Dantzer, O'Connor, Freund, Johnson, & Kelley, 2008). TCQ

is based on traditional Chinese medicine and aims to upskill people in mindfulness, self-

awareness and self-correction of posture, movement and breathing (Jahnke, Larkey,

Rogers, Etnier & Lin, 2010). TCQ is thought to alleviate physical and psychological

difficulty by stimulating the nervous system, leading to the release of endogenous

neurohormones and improvement of the immune system, while performing mind-body

exercises (Jahnke et al., 2010). Research suggests improvements in functional and

clinical outcomes (including SDi) following engagement with TCQ in adults (Dantzer et

al., 2008). No immediate benefits to PwD were observed. There were delayed in

benefits, however, which may be explained by a need to practice MBTs over time

before benefits are felt (Hubbling, Reilly-Spong, Kreitzer & Gross, 2014).

This study was of moderate methodological quality, suggesting bias may have

effected findings. It was unclear whether the 27% drop out rate biased the results-

double the number of participants who dropped out of the control condition dropped out

of the TCQ condition. It was unclear why participants dropped out TCQ, however,

participants were required to attend 2 60-minute TCQ classes a week for 2 months and

this may have been unacceptable or infeasible (Van Dam et al., 2018). A generalized

estimating equation model was used to manage missing data due to drop-outs,

meaning efforts were made to reduce attrition bias.

There is a lack in research into MBTs for SDi in dementia. Therefore it is not

possible to draw conclusions around wider benefits. Lengthy MBTs may render them

impractical. However, recent findings from the wider evidence base and this review

present preliminary evidence, justifying further research into MBTs, such as TCQ and

45

mindfulness (Kozasa et al., 2010; Winbush et al., 2007; Black et al., 2015; Paller et al.,

2015). The long-term benefits of MBTs may mean they are more beneficial for SDi than

activity and BLT interventions and further research may justify inclusion in clinical

guidelines.

Multi-component intervention

NITE-AD reportedly shortened night-time wakefulness in both studies exploring

this intervention. Preliminary evidence from the later, larger and higher quality study

suggests that continued engagement with NITE-AD maintained shortened night-time

wakefulness and also reduced the number of night-time awakenings. NITE-AD was

compared with BLT and activity interventions in this study and interestingly, NITE-AD

did not have superior effects on SDi. Other trials of BLT and activity are inconclusive,

therefore it is difficult to interpret why the effects of NITE-AD were comparable to these

interventions. Similarly, satisfaction for the NITE-AD was high, and comparable with that

of activity and BLT. This may have been because all interventions were delivered at

home (Jones, Andrieu, Knox & Mackell, 2010). Therefore, despite replicated evidence

(justifying incorporation into clinical quicance), the later study raises questions about the

superiority of NITE-AD over BLT and activity treatments.

Study personnel who delivered NITE-AD were licensed, experienced, highly

trained healthcare professionals over several sessions.Thus, given the individual nature

of the intervention, vast resources were required to implement it. Moreover, the authors

give a brief explanation of the intervention, however details of NITE-AD administration

were unclear, making it difficult to offer in practice.

46

Completeness and applicability of studies due to study design

Participants

RCTs generally had clear, pre-defined inclusion and exclusion criteria appearing

to reduce Selection Bias. As SDi is associated with all dementia subtypes, it was useful

that some studies investigated NPI efficacy across them (Zhao et al., 2016).

Conversely, it may be important to consider the heterogeneic neuropathology observed

across subtypes, as this may affect the efficacy of NPIs. For example, observed

neuropathologies in vascular dementia differ from that observed in AD (Zhao et al.,

2016). This may explain why differing efficacy results were observed in people with

vascular dementia and AD in a trial of BLT. These findings also suggest that differences

in treatment efficacy by dementia subtype may have been present, but undetected in

studies that did not perform these analyses.

All studies tested PwD’s severity of cognitive impairment using a cognitive

screening tool. Most studies used the Mini-Mental State Examination (MMSE; Folstein,

Folstein & McHugh, 1975), however others were used, which inevitably comprised of

slightly differing constructs, potentially introducing heterogeneity into the samples,

further obscuring the applicability of the findings. Most studies did not exclude people

based on dementia severity, meaning samples consisted of people with mild to severe

dementia. Analyses were not generally organised according to dementia severity,

therefore efficacy of interventions at stages of cognitive decline could not be

determined.

Ethnicity of participants was not reported by several studies. One study reported

an under-representation of participants from non-white backgrounds. Some studies

47

were conducted in other countries, meaning that the sample was likely largely non-white

(e.g. Hong Kong). Difficulties recruiting participants from ethnic minorities into clinical

trials are well documented (Areán & Gallagher-Thompson, 1996). However, some

ethnic minority groups are at higher risk of dementia; a lack of ethnic diversity among

participants reduced the representativeness of samples, making results less

generalisable (Tang et al., 2001). Moreover, under-representation of people from ethnic

minorities may inadvertently contribute to health inequalities.

The studies attempted to monitor and control biasing effects of sleep medication

in several ways: Some studies required medication was stable for a period before

participation, some noted medication at baseline or monitored changes throughout and

some kept medication “as constant as possible”. It was unclear whether changes in SDi

found by studies were biased by changes in medication. Some studies excluded

participants using sleep medication completely- these samples likely lacked ecological

validity.

Comorbid diagnoses are common within the dementia population and studies

excluding these participants may lack ecological validity and generalisability. With

regards to inclusion of participants with co-morbid diagnoses, different approaches were

held across studies. Research shows that sleep is implicated in several physical and

mental health conditions. For example, serotonin secretion is implicated by the immune

system, depression and anxiety and sleep, suggesting the potential for a variety of

aetiologies and effects of SDi (Imeri & Opp, 2009). Therefore, the inconsistencies

across studies in the monitoring of co-morbid diagnoses may have obscured efficacy

findings.

48

Several studies were conducted in residential settings. Evidence suggests

people in care homes have more severe dementia, coinciding with higher severity of

SDi (Wennberg et al., 2017). These interventions may not be generalisable to

community-dwelling PwD. There was a shortage of research in community-dwelling

PwD (Brown, Devanand, Liu & Caccappolo, 2011).

In summary, there was lack of consensus in how studies assessed for cognitive

impairment and managed people on sleep medication and with comorbid diagnoses.

Consequently, heterogenerity was introduced into the sample, generating incomparable

groups. Moreover, few studies analysed based on these characteristics, or by dementia

subtype, meaning opportunities to investigate whether treatments may benefit some

were missed. A lack in ethnic diversity, and studies conducted in the community may

also have reduced the generalisability of the findings.

Interventions

Previous reviews of NPIs for SDi in dementia highlighted studies of BLT, physical

and social activity, behavioural and multi-component (NITE-AD) interventions. Two new

RCTs of NPIs (BLT, activity and NITE-AD; MBT), suggesting research has moved away

from solely assessing BLT, as per previous review recommendations (Forbes et al.,

2014). Interventions assessed in PwD largely resemble interventions tried in older

adults. However, social, resilience and coping-skills training has not been applied in

PwD, despite evidence suggesting benefits to SDi in older adults (Manning, 2014). This

may be because the cognitive decline experienced by PwD may reduce their ability to

engage with such interventions (e.g. Steinhardt, 2007). They too are resource intensive

(delivered by highly trained professionals; requiring several weeks’ engagement). There

49

may be more pragmatic MBTs (e.g. guided brief Mindfulness-Based Interventions), that

haven’t yet been tried in PwD but provide promising results for SDi in older adults

(MacLeod, Musich, Kraemer & Wicker, 2018). There was a lack of acceptability data,

which would inform the development of interventions (Moore et al., 2015; Eckert &

Hintz, 2000).

Outcome measures

Across studies, there were differences in quantitative sleep quality measures

used. Several studies used actigraphy, sometimes alongside sleep charts. One study

reportedly used qualitative data. There were discrepancies in frequencies and types of

outcome data collection across studies, introducing information bias. Actigraphy data is

problematic as it may detect movement that looks like wakefulness on observation of

the quantitative data, when PwD may be moving in their sleep. Some studies did not

supplement actigraphy with a method of interpreting actigraphy data (e.g. sleep diary).

Thus, calculations may have been inferred, and inaccurate. Actigraphy compliance

varied across studies (and was sometimes not reported), causing missing data and

increasing Reporting bias.

The Pittsburgh Sleep Quality Index (PSQI) is considered the “gold standard”

assessment of SDi in older adults, which taps a broad range of constructs. (Landry,

Best & Liu-Ambrose, 2015). One major drawback of the PSQI is its retrospective nature-

particularly for use in PwD, who have retrospective memory difficulties (Smith &

Wegener, 2003). Consequently, recall bias may have affected responses. Evidence

suggests a cut-off score of 8 would be most appropriate for older people, instead of a

score of 5 used by included studies (Smith & Wegener, 2003). The Medical Outcomes

50

Study sleep measure was also used; despite adequate reliability, there is a lack in

validity data, meaning it is unclear how applicable the constructs are to PwD (Smith &

Wegener, 2003). Similarly, evidence suggests the Epworth Sleepiness Scale may be

unapplicable to older people, leading to potential underestimations of SDi (Onen,

Moreau, Gooneratne, Petit, Falissard, & Onen, 2013).

Overall, differing quantitative assessment measures led to the measurement of

different constructs, resulting in the reporting of differing sleep parameters across

studies. Assessment intervals varied, with some studies analysing activity data

continuously throughout studies and others using a pre- and post-intervention model,

further clouding the ability to interpret NPI efficacy. Many studies did not conduct follow-

up analyses, making it impossible to ascertain whether efficacy of interventions was

maintained long-term.

There was a lack of qualitative data collected across studies, with acceptability of

interventions among PwD and caregivers being infrequently reported. One study

provided treatment satisfaction and acceptability qualitative data, and caregivers

disclosed that BLT, activity and NITE-AD interventions were acceptable. However, it

was unclear who contacted caregivers, what tools were used to extract evaluations (e.g.

interviews) or if any qualitative analysis was conducted. Subjective perceptions of

intervention efficacy were not collected. Thus, it was unclear which, if any, NPI PwD and

caregivers preferred, or which characteristics incerased acceptability. Considering the

neurodegeneration experienced by PwD, collecting qualitative data poses challenges

(McKeown, Clarke, Ingleton & Repper, 2010). However, it may provide vital information

on intervention acceptability and perceived efficacy.

51

Certainty of the evidence due to methodological quality of studies

RoB caused by 6 constructs was assessed in each study, contributing to overall

RoB scores, which indicated methodological quality. One trial was of “high

methodological quality”; 9 were of “moderate methodological quality”; and 4 were of “low

methodological quality”. Therefore, despite this review aiming to synthesise “high-

quality” research, the evidence base for NPIs for SDi in dementia appears to lack trials

of the standard expected by this review.

High risk of Performance Bias was most prevalent. Research shows that, after

receiving a placebo NPI, improvements in SDi were observed in adults with insomnia

(Yeung, Sharpe, Glozier, Hackett & Colagiuri, 2018). This suggests participants in

intervention conditions may overinflate their responses, resulting in increased

Performance Bias, potentially leading to Type I errors. Further, Performance Bias may

result from participants receiving differential treatment from study personnel delivering

interventions (Van Dam et al., 2018). Prevalent Performance Bias also increased

Detection Bias, despite blind outcome assessors, as several studies used self-report

measures.

The occurrence of high-risk of Attrition Bias was problematic. Most studies

reported the number of drop-outs, however several omitted reasons for drop-outs.

Consequently, for some studies, it was unclear whether drop-outs led to the

unbalancing of confounding variables across conditions, reducing the validity of results.

Several studies retained smaller samples than anticipated, meaning some statistical

analyses were underpowered to support claims. Most studies did not report using a

strategy to manage missing data, therefore it was unclear which data were used to

52

assess outcomes. Additionally, most RCTs did not report using an intention-to-treat

analysis, therefore analyses may lack ecological validity. Since some studies did apply

intention-to-treat analysis and some did not, it would be inequitable to compare efficacy

of NPIs across trials. Overall, these findings raise questions about the validity of results,

making it impossible to draw conclusions about the comparative efficacy of interventions

across studies.

There was a selection of Other Biases presented by the studies, likely due to

varied legitimate challenges posed by this area of research. However, the impact of

which on the overall evidence was unfeasible to assess and thus, the ability to compare

the efficacy of interventions considering these factors was reduced.

Risk of Reporting Bias was least prevalent across studies. This was particularly

positive as, research into NPIs for SDi in dementia is a relatively novel area, and early

studies provide a foundation of results upon which future studies will build. Notably,

despite the “moderate” to “low methodological quality” of most studies, both significant

and insignificant results were presented. These findings suggest that currently, the

evidence is not overly skewed and provides information on ineffective interventions (e.g.

BLT).

Overall, widespread RoB reduced certainty of evidence meaning currently, it is

not possible to deduce whether activity, MBT or NITE-AD interventions are most

efficacious in ameliorating SDi in dementia. Further high-quality research is necessary,

particularly to evidence activity and MBTs. However, nonsignificant findings following

BLT suggest this treatment may be ineffective in ameliorating SDi in dementia.

53

Guidance for future research

Despite numerous studies, at present, the evidence base cannot justify effective

BLT for SDi dementia. Should researchers wish to explore this treatment, it would be

most ethical to build on the current evidence base by replicating published studies that

have yielded significant findings to test the reliability of BLT efficacy.

This review suggests evidence for NITE-AD and preliminary evidence for activity

and MBTs. Replications and novel research would strengthen support for these

interventions. Importantly, novel research into truncated versions of NITE-AD, activity

and MBTs, deliverable in the context of a stretched health service, are worth exploring.

Additionally, publication of treatment protocols would enable intervention uptake by

healthcare service providers.

Future researchers should consider collecting qualitative data from PwD and

caregivers to ascertain intervention acceptability, as this influences engagement and

subjective efficacy (Eckert & Hintz, 2000). Subjective opinions of efficacy of

interventions may also be insightful.

To increase generalisability of results, future studies would benefit from making

concerted efforts to recruit people from non-white backgrounds. With regards to the

management of heterogeneity in samples, analyses of treatment efficacy in pre-defined

sub-sets of participants are likely to be informative (e.g. mild vs. moderate cognitive

impairment). Researchers should use their discretion in developing inclusion and

exclusion criteria- for example, it may be sensible to exclude people with co-morbid

diagnoses (e.g. heart disease) from preliminary studies while interventions are being

developed.

54

There is a clear need for future efficacy studies to be of high-quality to truly build

evidence. Studies would benefit from reporting sleep outcomes consistently (e.g. PSQI,

pre- and post-intervention). Longitudinal data would enrich the evidence base further.

Future studies may benefit from employing creative methodologies, enabling

concealment of randomisation from study personnel and participants. This may involve

trialling 2 active conditions, or control conditions incorporating generic therapy

characteristics (Van Dam et al., 2018). Lastly, future researchers should conduct

feasibility studies to highlight and generate controls for other potential biases presented

by the intervention, study design, participants and study personnel.

Limitations

The conduct and reporting of this review were guided by the Cochrane Handbook

for Systematic Reviews and PRISMA reporting guidelines, which provide best

evidenced guidance for the conduct and reporting of systematic reviews (Higgins et al.,

2011; Moher et al., 2009). This minimised introduction of bias into the review process.

However, this systematic review was not registered with PROSPERO, meaning

comparison of the completed review with what was planned at inception was not

possible. This reduced the ability to assess reporting bias. Additionally, this review may

be duplicated.

Three large databases were used to extract included articles. The author was

unable to gain access to 1 article. However, this study of BLT has been reviewed before

and did not change the general evidence for BLT. Whilst the researcher is confident that

all relevant articles were identified, it would have been useful to query additional

databases (e.g. PsychInfo) to ensure completeness of the review. By not doing so, the

55

researcher cannot be certain that all papers were identified. Manual searching of

reference lists of reviews, and consulting with 2 supervisors in selecting included papers

likely helped with this. Incusion and exclusion criteria of this review meant some

relevant papers may have been excluded - for example, this review only included

papers available in English. Consequently, this review may not have considered all

NPIs explored for SDi in dementia and therefore may have overlooked a potentially

effective NPI.

Assessment of RoB required the researcher to use judgement, which may have

introduced bias. Moreover, ratings were conducted solely by the researcher and

verification by another person would have increased validity of ratings. The absence of

this process may have reduced rigor and consequently, utility of this review.

Classification of studies as “high”, “moderate” and “low methodological quality” was

constructed by the researcher for illustrative purposes. Despite classifications being

based on the studies, categories are not established nor rooted in concrete evidence.

Therefore, the importance of these labels should not be overstated. There was no

quantitative synthesis of data (i.e. no meta-analysis; sub-group analyses) and

consequently, it was not possible to draw conclusions about which NPI was superior in

reducing SDi in PwD.

Conclusion

SDi in dementia is prevalent and is detrimental to PwD and caregivers.

Pharmacological treatments of SDi present severe risks to PwD and there is no

evidence for their long-term efficacy. Previous reviews presented inconclusive support

for BLT, exercise, passive body heating and NITE-AD interventions. They also

56

highlighted issues with the quality of studies in this area. This review aimed to provide

an up to date synthesis of evidence, restricting included studies to RCTs.

A total of 14 articles were included and reported on BLT, activity, NITE-AD and

MBT efficacy in alleviating SDi in dementia. There was a lack of non-white, community-

dwelling participants, impacting the generalizability of the results. There was

heterogeneity in the samples (e.g. with regards to cognitive impairment) raising the

possibility of confounding variables. Most studies were not of “high methodological

quality” and therefore, there was a high RoB (particularly Performance Bias) introduced,

reducing conviction in the results.

Findings from this review suggested there remains no consistent evidence for the

immediate or long-term benefits of BLT, consistent with previous reviews. There was a

scarcity of research into activity, MBT and NITE-AD interventions. Preliminary evidence

suggested support for immediate benefits of walking and individualized activities. These

findings were not sustained at long-term follow-up and may suggest issues with the

long-term uptake of these interventions. Moreover, the presence of mixed results and

the “low methodological quality” of one activity study restricted conviction in results.

There was preliminary evidence to suggest long-term benefits of an MBT. Notably, the

quality of this study was among the highest, although there was a considerable drop-out

rate. The reproduced study of NITE-AD replicated benefits to SDi seen in an earlier

study, providing a preliminary evidence base for this intervention. This study was also

among the highest of quality. Further, qualitative reports suggested NITE-AD was an

acceptable intervention.

57

Despite evidence for NITE-AD and preliminary evidence for activity and MBT

treatments, they may be infeasible for public healthcare services to provide in practice,

due to the vast resources required. There is a need for these treatments to be

developed into pragmatic interventions, deliverable in the context of a variety of

healthcare services. Emerging evidence suggests that adapted, brief MBTs, requiring

few resources are efficacious in reducing SDi in older people, however, they are yet to

be investigated in PwD (Kozasa et al., 2010; Winbush et al., 2007; Black, O’Reilly,

Olmstead, Breen & Irwin, 2015; Paller et al., 2015.) The evidence base would benefit

from exploring acceptability and efficacy of novel interventions such as adapted, brief

MBTs in PwD. Explorations into the feasibility of such a study would allow for

identification and management of challenges that could interfere with the valid, reliable

conduct of an RCT. This is of importance, as producing high quality research in this

area must be a priority. Lastly, there is a need for concrete guidance on how to

administer the treatments.

58

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Part 3: Clinical Experience

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Adult Placement- Community Mental Health Recovery Service

This placement enabled an understanding of a variety of social care issues. I

gained experience working with community mental health nurses and psychiatrists. I

begun to apply Cognitive Behavioural Therapy (CBT) skills, with a variety of

presentations (depression, anxiety, agoraphobia, trichotillomania). I co-facilitated a

Mood on Track group, a CBT group for people diagnosed with Bipolar Disorder. I

learned the principals of administering and scoring neuropsychological assessments. I

gained an understanding of supervision and how best to use it, which informed later

supervisory relationships, and maximised clinical learning during supervision.

Child Placement- Child and Adolescent Mental Health Service

I conducted comprehensive mental health assessments with children, parents

and families. Mental health presentations were varied and had a spectrum of effects on

school and home life. Social care problems were also prevalent. As such, this

placement enabled work alongside an array of professionals including psychiatrists,

teachers, SENCOs and social workers. Work within the Access service required

signposting creatively, and therefore knowledge of local services. Skills in conducting

neuropsychological assessment for learning disability in children and young people

were developed, both practically and clinically (i.e. collaboratively selected appropriate

tests with supervisor). I also developed skills in interpretation of neuropsychological

assessment and feeding back to young people, parents, schools and the wider network

where indicated. I conducted CBT with young people (low mood and anxiety). I gave a

presentation on “Culturally Centred Formulations” as per my interests.

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Learning Disability Placement- Community Learning Disability Team

I worked with a variety of professionals including Care Home Managers, Carers,

Social Workers, Deprivation of Liberty Safeguard assessors, Occupational Therapists,

Physiotherapists, Nurses, Psychiatrists, Assistant Psychologists. I used the Positive

Behaviour Support Framework for “behaviour that challenges” work, which involved

conducting extended assessments, functional analyses and observations, leading to

reports and recommendations. I contributed to ASD assessments based on ICD-10

criteria. I also assessed for sexual awareness and provided sexual education support. I

used neuropsychological assessment to contribute towards a diagnosis of a learning

disability and dementia. I fed these back to the assessed and the network as

appropriate (including in the form of a report).

Specialist Placement- Adult Neurorehabilitation Service

I worked in acute neurorehabilitation wards, conducting initial psychological

assessments, and follow up work with people in the wards. I participated in multi-

disciplinary goal planning meetings. I supported assistant psychologists (e.g. provided

consultation around behavioural activation work). I supported neuropsychological

assessments through administering tests, writing and amending reports, feeding back

results (jointly with Occupational Therapist assessment feedback), providing

recommendations and disseminating as appropriate. I did joint work with occupational

therapists and one-to-one CBT. I facilitated the vocational neurorehabilitation group

(psychoeducation; Cognitive Behavioural Therapy). I co-authored a published article,

(Boakye, N. T., Scott, R., Parsons, A., Betteridge, S., Smith, M. A., & Cluckie, G. (2019).

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All change: a stroke inpatient service’s experience of a new clinical neuropsychology

delivery model. BMJ Open Qual, 8(1), e000184.)

Older Adult Placement- Community Older People’s Team, Behaviour and

Communication Support Service, Memory Assessment Service.

I conducted neuropsychological assessments of older people presenting with

memory difficulties (i.e. explaining the remit of neuropsychological assessment; gaining

consent; collecting a history; collecting collateral information; selecting

neuropsychological tests based on hypotheses (and adapting these tests in light of new

information); conduct of the tests; interpretation of the tests; feedback of results; and

preparation and dissemination of neuropsychological report.) Within the Behaviour and

Communication Support Service, I used the Newcastle Model to support older people

presenting with behaviours that challenged. This involved working closely with carers

and families to gather background and clinical information, conducting several

observations and assessing the function of behaviours that challenged. This work also

enabled me to challenge current thinking about the behaviours, share formulations with

teams and provide a general understanding of the functions of behaviours that

challenge (i.e. to meet a need). I also used a Narrative and CBT approaches to support

carers (who were supporting family members with dementia) and an older person with a

mental health difficulty. I worked among psychiatrists, nurses, occupational therapists

and assistant psychologists. I supervised the assistant psychologist in conducting a

service evaluation. I also gave a presentation on “Treatments for Sleep Disturbance in

Dementia” as this was the focus of my thesis.

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Part 4: Assessments

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TABLE OF ASSESSMENTS COMPLETED DURING TRAINING

Year I Assessments

ASSESSMENT TITLEWAIS WAIS Interpretation (online assessment)

Practice Report of Clinical Activity

Psychological assessment of a 63-year-old Mauritian man with a diagnosis of agoraphobia and a history of depression.

Audio Recording of Clinical Activity with Critical Appraisal

Graded Exposure Therapy with of a 52-year-old Jamaican woman with symptoms of panic disorder with agoraphobia comorbid with a diagnosis of Schizophrenia/Schizoaffective disorder.

Report of Clinical Activity N=1

Cognitive Behavioural assessment and treatment of a 52-year-old Jamaican-British woman diagnosed with schizophrenia/schizoaffective disorder with a focus on panic disorder with agoraphobia

Major Research Project Literature Survey

Non-pharmacological treatments for sleep disturbance in older adults with dementia: A literature survey

Major Research Project Proposal

A prospective cohort study examining the feasibility, acceptability and preliminary efficacy of a mindfulness-based intervention for sleep disturbance in older adults with Alzheimer’s disease.

Service-Related Project An audit of the quantity and quality of Recovery Goals set in a Community Mental Health Recovery Service.

Year II Assessments

ASSESSMENT TITLEReport of Clinical Activity – Formal Assessment

Neuropsychological assessment of a woman in her early 70s, presenting with subjective memory complaints, anomia and changes in activities of daily living.

PPLD Process Account

Reflecting on how being a member of a Personal and Professional Developmental Learning Group has contributed to my personal and professional development.

Year III Assessments

ASSESSMENT TITLEPresentation of Clinical Activity

CBT informed assessment and intervention of an adolescent female presenting with low mood and anxiety.

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Major Research Project Literature Review

Non-Pharmacological Interventions for Sleep Disturbance in Dementia: A Systematic Literature Review

Major Research Project Empirical Paper

A cohort study assessing the feasibility of an RCT and acceptability and preliminary efficacy of a guided brief Mindfulness-Based Intervention for Sleep Disturbance in Dementia

Report of Clinical Activity

A Functional Assessment and Positive Behaviour Support Plan for a man in his 50s with an Intellectual Disability and an Autistic Spectrum Disorder presenting with behaviour that challenges.

Reflective PortfolioOn becoming a clinical psychologist: A retrospective, developmental, reflective account of the experience of training.

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