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Telephone-based coping skills training for patients awaiting lung transplantation
The INSPIRE Investigators Duke University Medical Center,
Durham, NCWashington University Hospital,
St. Louis, MO
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Background• Awaiting lung transplantation is
usually highly stressful• Rate of depression and anxiety
disorders is ~45% and 50% respectively
• Daily function is often compromised• Mortality rate among listed patients
is 30%
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•Severity of Illness•Geography
Barriers to Psychosocial Intervention
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Possible approach?
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INSPIRE
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Purpose• To evaluate the efficacy of a
telephone-based psychosocial intervention for patients awaiting lung transplantation with respect to:
• Psychological well-being• Daily function/Quality of life• Survival while awaiting transplant
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Methods• Dual-site randomized clinical trial • Coping Skills vs Usual Care• Randomization stratified by cystic
fibrosis/non cystic fibrosis and time on waiting list
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Eligibility Criteria• Male or female outpatients 18 years
of age• A diagnosis of end-stage pulmonary
disease and currently on the active list for lung transplantation
• Capacity to give informed consent and follow study procedures
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Exclusion Criteria• dementia• delirium• psychotic features including
delusions or hallucinations• acute suicide or homicide risk
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DESIGN
CST
Assessment Assessment
UsualCare
12 Weeks
Follow-up
2 years
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Interventions
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Coping Skills Training• 12 Weekly sessions of 30-45
minutes• Workbook• Therapy sessions randomly
selected for adherence to protocol• Therapists received routine
supervision from senior therapist
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Usual Care• Monthly monitoring• Maintain usual level of contact with
transplant team• Continue usual medications• Referred to psychological
treatment if necessary
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Analytic Strategy• Similar to General Linear Model• Intent-to-treat• Propensity score approach with ML
imputation• Propensity scores adjust for baseline
value of response, age, ethnicity, income, education, gender, diagnosis, hx of psychiatric tx
• Results similar between CACE and ITT
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Patients on candidate list screened from 12/00 to 7/04
(N = 533)
Consented(N = 411)
Completed baseline assessments
(N = 389)
CST(n = 200)
Usual care control(n = 189)
Patient Flow
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Attrition Analysis
Reason for attrition CST N = 200
UCN = 189
TotalN = 389
Deceased 5 (2.5) 8 (4) 13 (3.3)
Transplanted 26 (13) 18 (9.5) 44 (11)
Delisted 3 (1.5) 1 (0.5) 4 (1)
Dropped out 25 (12.5) 3 (1.5) 28 (7.2)
Completed tx but not post tx assessment
15 (7.5) 12 (6.3) 27 (6.9)
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N = 126 (63/78%)
N = 147 (78/98%)
Final Completion Rate:N = 273
UCCST
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N = 166 N = 162
Sample Size for AnalysisN = 328
UCCST
Completers (273) + Dropouts (28) + No post-tx Assessment (27) = 328
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Results
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Background CharacteristicsVariable CST UCAge, yrs, mean (SD) 50 (11) 50 (12)Male N (%) 75 (45) 69 (43)Caucasian, N (%) 147 (89) 140 (86)Education > HS, N (%) 104 (64) 103 (63)Annual Income > $50K, N (%)
66 (40) 64 (40)
Hx of Psychotropic medication, N (%)
44 (27) 45 (28)
Hx of Psychotherapy, N (%)
9 (5) 9 (6)
BDI Score, mean (SD) 13 (8) 11 (7)PQLS Score, mean (SD) 70 (17) 72 (15)GHQ Score, mean (SD) 49 (24) 45 (19)Sf-36 Mental Health Score, mean (SD)
23 (5) 24 (4)
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Attrition analysis: Odds of dropout
0.50 1.50 2.50 3.50 4.50 5.50
cbt - 1:0
ghqtott1 - 60:30
white - 1:0
female - 1:0
cf - 1:0
copd - 1:0
somecollege - 1:0
incgt50k - 1:0
psymeds - 1:0
psytx - 1:0
sf36menhltht1 - 27:22
bditott1 - 16:6
saitott1 - 45:28
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05
1015202530354045
% o
f Gro
up
Usual CareCST
Pulmonary Diagnoses
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Status N = 200All 12 sessions 126 (63)At least 8 sessions
148 (74)
No sessions 17 (8.5)
Adherence: Therapy Sessions Attended
Values are N (%)
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Mental Health Outcomes
• Beck Depression Inventory• General Health Questionnaire• Spielberger State Anxiety Scale • SF-36 Mental Health • SF-36 Vitality• Perceived Stress Scale• Perceived Social Support
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28
32
36
40
44
CST UC
SAI
State Anxiety
p = .040
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6
8
10
12
14
16
18
CST UC
BDI
Depressive Symptoms
p = .002
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30
35
40
45
50
55
60
CST UC
GHQ
General Health Questionnaire(negative affect)
p = .027
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21
22
23
24
25
26
27
CST UC
MH
SF36 Mental Health
p = .0005
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9
10
11
12
13
14
15
CST UC
VIT
SF36 Vitality
p = .0005
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14
16
18
20
22
24
26
CST UC
PSS
Perceived Stress
p = .008
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646668707274767880
CST UC
PSSS
Perceived Social Support
p = .06
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-1.00 -0.75 -0.50 -0.25 0.00 0.25 0.50 0.75 1.00Effect (SD)
CSTUsual CareBDI
GHQ
Anxiety
SF 36MH
Effect Sizes
SF 36Vit
Stress
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“Depression” (BDI > 10)
No Change
Improved Worse
Usual Care
101 (63) 49 (30) 12 (7)
CST 92 (55) 70 (42) 4 (2)
Values are N (%)
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AnxietyNo Change
Improved Worse
Usual Care
92 (57) 53 (33) 17 (10)
CST 89 (53) 70 (42) 7 (4)
Values are N (%)
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Therapy-related reduction in depression and anxiety
• OR for post-CST depression = 0.395– p = .004
• OR for post-CST anxiety = 0.537– p = .031
Based on logistic regression model adjusting forbackground covariates and status at study entry
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Quality of Life/Physical Function
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50
55
60
65
70
75
80
85
90
PQLS
CSTUC
Poor
Better
Pre-Treatment Level
Pulmonary Quality of Life
p = .003
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5
5.2
5.4
5.6
5.8
6
CST UC
ERSF36 Emotional Role
p = .616
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7
8
9
10
11
CST UC
PainSF36 Pain
p = .531
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4
4.5
5
5.5
6
CST UC
PRSF36 Physical Role
p = .512
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5
5.5
6
6.5
7
CST UC
SFSF36 Social Function
p = .597
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7
8
9
10
11
12
13
CST UC
GH
SF36 General Health
p = .751
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48
53
58
63
68
73
78
CST UC
SOB
Shortness of Breath
p = .738
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Survival
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Days
log(
Pro
babi
lity
of S
urvi
val)
0 200 400 600 800 1000 1200
0.8
0.9
1.0
--- CST, 22 (11%) Deaths--- Usual Care, 21 (11%) Deaths
Survival Until Transplant
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Days
log(
Pro
babi
lity
of S
urvi
val)
0 200 400 600 800 1000 1200
0.5
0.6
0.7
0.8
0.9
1.0
--- CST, 38 (19%) Deaths--- Usual Care, 26 (14%) Deaths
All Survival
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• Telephone-based therapy is a feasible psychological intervention among pulmonary transplant candidates
• Behavioral interventions are associated with reduced depression and general distress relative to usual care
• Behavioral interventions are associated with improved pulmonary quality of life among sicker patients
• No apparent effect on physical function or survival
Conclusions
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Intervention & Session Topics
• 1 Introduction to the program• 2 Review of your life story• 3 Progressive relaxation training• 4 Mini-practices (relaxation)• 5 Goal setting I: pleasant activities• 6 Goal setting II: rest-activity cycles• 7 Calming self-statements I• 8 Calming self-statements II• 9 Problem-solving I• 10 Problem-solving II• 11 Preventing and dealing with setbacks• 12 Review and Maintenance
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Variable Before Tx After Tx
SH36 Mental Health 0.893 0.873
BDI 0.839 0.847
GHQ 0.861 0.848
State Anxiety 0.821 0.870
Mental Health Outcomes as a “Factor”
Correlation between Before and After = 0.74, P < .0001
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Treatment Effect on Negative Affect
• CST associated with Improvement on Negative Affect Factor, p < .001
• CST accounted for about 3.5% of the variance in post-treatment negative affect
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• Phone-based CST was associated with– Reduced depression– Reduced anxiety– Improved pulmonary QOL– Improved general well-being
Napolitano et al., Chest, 2000
Pilot Study
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• Study sample small, limited power (N= 71)
• Therapist also performed assessments
• No assessment of medical outcomes