2. 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%)

3. 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

4. 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

5. 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

6. Study Design RAISE Early Treatment Program Community Care All services at your center decided by best clinical practice NAVIGATE An experimental package of services

7. Early Treatment Program Sites

8. 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

9. 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

10. 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

11. NAVIGATE Services  Pharmacological Treatment  COMPASS- A decision support system for prescribers  Family Education Program (FEP)  Supported Employment and Education (SEE)  Individual Resiliency Training (IRT )

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. 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

19. Family Introduction to the NAVIGATE Program  The NAVIGATE program is designed to help a person who has experienced a psychotic episode, and his/her relatives and supporters, learn the skills and information needed to help the person get back on his/her feet, and work towards having a rich and full life.  The NAVIGATE program involves a number of different interventions, including medication, individual resiliency training (IRT), help getting back to work or school (Supported Employment and Education or SEE), and a family support/education program to increase the chances of recovery from psychosis.  These interventions have been shown to be effective in helping people get on with their lives after they have experienced a psychotic episode. There is hope 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 with his/her goals including a doctor, program director, a clinician for counseling and resiliency training, and an expert on work and school issues. He/she will learn coping strategies that will help him/her better manage his/her situation and reach his/her goals.

20. INTRODUCTION TO JUST THE FACTS 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.

21. INTRODUCTION TO JUST THE FACTS 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.