Long-Term Course of Schizophrenia

1% prevalence of schizophrenia 1/3 of all mental health care spending in the

U.S. on schizophrenia treatment Indirect costs of schizophrenia high: loss of

work, time and money spent by caregivers, law enforcement costs, etc.

World Health Organization rated schizophrenia 2nd most burdensome disease in world (15%), after cardiovascular disease (18%)

The Problem of First Episode Psychosis

Poor recognition

Longer duration of untreated psychosis related

to worse outcomes

High rates of medication non-adherence

High rates of dropout from treatment

The NIMH RAISE Project

The National Institute of Mental Health Recovery After an Initial Schizophrenia Episode (RAISE) Project will test whether early, aggressive, and pre-emptive intervention can slow or halt clinical and functional deterioration in schizophrenia

RAISE research objectives:– Design and test effective interventions for early

phase schizophrenia – Engineer rapid adoption and implementation of

effective treatment packages by engaging “end users” at the start of intervention development

– Assess clinical, functional, and economic outcomes– Generate information relevant to key stakeholders,

including health care policy makers

The NIMH RAISE Project

NIMH awarded separate contracts to two independent research teams: The Early Treatment Program at the Feinstein

Institute for Medical Research in Manhasset, NY The Connection Program at the Research

Foundation for Mental Hygiene at Columbia University in New York, NY

The Early Treatment Program has been funded in whole or in part with Federal funds from the American Recovery and Reinvestment Act of 2009 and the NIMH/NIH/HHS under Contract No. HHSN-271-2009-00019C

Study Design

RAISE Early TreatmentProgram

Community Care NAVIGATE

All services at your center decided by

best clinical practice

An experimental packageof services

Early Treatment Program Sites

RAISE ETP Study Methods

Groups were assigned randomly 18 Navigate sites 17 Community Care sites

The study will compare the two groups The study will go on for almost 4 years People who join the study will be treated and

assessed for at least 2 years All participants have the same assessments

Diagnosis and outcome assessment by clinical raters will use live video connection

Diagnostic results and laboratory assessments will be provided to clinicians at all sites

RAISE ETP Study Participants

Sample size: 400 10 – 20 at each site

Age 16-40 One of these diagnoses is in the differential

schizophreniform disorder schizophrenia schizoaffective disorder psychotic disorder NOS brief psychotic disorder

Less than four months of lifetime treatment with antipsychotic medications

RAISE ETP Study Outcomes

Primary outcome measure: Quality of Life Primary hypothesis

NAVIGATE intervention will improve Quality of Life significantly more than Community Care

Other measured outcomes Service utilization Cost Consumer perception Prevention of relapse Recovery

NAVIGATE Services

Pharmacological Treatment COMPASS- A decision support system for

prescribers

Family Education Program (FEP)

Supported Employment and Education (SEE)

Individual Resiliency Training (IRT)

Pharmacological Treatment

General Principles: Recommendations should be based upon data; avoid expert

hunches about treatment

Preference given to medications with data from studies with

the relevant patient groups

Consider the use of long-acting formulations of

antipsychotics for maintenance treatment for all subjects

COMPASS incorporates these principles and provides

an ongoing record of treatment and clinical response

Family Education Program (FEP)

Provide family (including client) with education about psychosis, coping strategies, skills or communicating and solving problems

Goals Shore up relationships for the long haul

Change the trajectory of the illness by supporting resumption of role functioning and social pursuits

Reduce stress and burden in family members

Supported Employment and Education (SEE)

Helps clients get back on track with work or school

The goal of SEE is to help people develop and

maintain personally meaningful goals related to their

careers, their education, and their employment

SEE services are individualized for each person based

on their preferences, goals, and values

SEE services are provided based on the person’s

choice to pursue employment or education, or both

Individual Resiliency Training

Assists clients in learning about psychosis, processing experience, developing relapse plan, increasing resiliency, learning specific strategies and skills to achieve own personal goals; also provides case management

IRT AIMs to promote recovery From an initial episode of psychosis via

identifying client strengths.

Enhancing illness self management skills

Summary of RAISE ETP

A novel Clinical Trial Model Client's consent does not involve randomization Treatment provided openly mirrors clinical

reality Valid assessment by centralized clinical raters

using live video connection Long term treatment – at least two years Multi-dimensional treatment incorporating

known elements Team based Shared decision making

RAISE ETP Study Contacts

PeaceHealth/LaneCounty Mental Health Eugene, OR

Project Director – Carla Gerber Research Assistant – Linda Gonzales Contact information

Telephone 541-682-7561

Email cgerber@peacehealth.org

Who can participate in the study?

Age 16 – 40 Clinical diagnosis includes possibility of

Schizophrenia Schizophreniform disorder Schizo-affective disorder Psychosis NOS

No more than 120 days of anti-psychotic medication Taken not prescribed

Family Introduction to theNAVIGATE Program

The NAVIGATE program is designed to help a person who has experienced apsychotic episode, and his/her relatives and supporters, learn the skills andinformation needed to help the person get back on his/her feet, and worktowards having a rich and full life.

The NAVIGATE program involves a number of different interventions,including medication, individual resiliency training (IRT), help getting back towork or school (Supported Employment and Education or SEE), and a familysupport/education program to increase the chances of recovery frompsychosis.

These interventions have been shown to be effective in helping people get onwith their lives after they have experienced a psychotic episode. There ishope for recovery.

Participants will learn strategies that will them support the person in NAVIGATE to pursue his/her goals and get on with his/her life.

The person in NAVIGATE will be working with a team to help him/her withhis/her goals including a doctor, program director, a clinician for counselingand resiliency training, and an expert on work and school issues. He/she willlearn coping strategies that will help him/her better manage his/hersituation and reach his/her goals.

INTRODUCTION TO JUST THEFACTS SESSIONS

We believe that recovery chances are increased if everyone in the family—

the person in NAVIAGATE and the key supporters of the person with a first episode of psychosis-- learns about the disorder and what can be done to

improve the situation. The “Just the Facts” educational handouts review eight basic

topic areas critical to first episode psychosis: · Facts about Psychosis. · Facts about Medication. · Facts about Coping with Stress. · Facts about Developing Resiliency. · Relapse Prevention Planning. · Developing Collaboration with Mental Health Professionals. · Effective Communication. · Learn tips for addressing substance use if that is an issue in your family. A Relative’s Guide to Supporting Recovery from Psychosis. In addition, there is an optional handout on substance use and psychosis.

INTRODUCTION TO JUST THEFACTS SESSIONS

· Each topic area will typically be discussed with the family clinician in one or two sessions. When you review the handouts with your family clinician, you will discuss each topic area and have an opportunity to ask questions and voice your concerns. You will: · Review and discuss the symptoms of psychosis. · Learn how the stress-vulnerability model can help you understand the biological and environmental factors associated with psychosis and how to reduce vulnerability. · Learn facts about medications used to treat psychosis including the advantages and disadvantages and the side effects associated with them. NAVIGATE Family Manual – Just the Facts Family Handouts Page 82 · Develop strategies to help support the relative in NAVIGATE taking medication regularly. · Identify areas of stress and strategies to cope more effectively with those stressors. · Develop a plan to cope more effectively with stress. · Learn how developing resiliency can help all move forward to support the relative in NAVIGATE’s recovery. · Identify early warning signs of relapse. · Prepare for possible flare-ups of symptoms. · Learn how to work closely with the relative in NAVIGATE’s treatment team. · Understand confidentiality laws. · Sharpen up communication. · Learn the benefits of keeping family conflict low to help support recovery. · Recognize the importance of everyone in the family continuing to build his or her own life.