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-2712009-00019C
Study Design
RAISE Early Treatment
Program
Community Care
NAVIGATE
All services at your
center decided by
best clinical practice
An experimental package
of 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
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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
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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
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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
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Telephone 541-682-7561
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Email
cgerber@peacehealth.org
Who can participate in the
study?
 Age 16 – 40
 Clinical diagnosis includes possibility of
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Schizophrenia
Schizophreniform disorder
Schizo-affective disorder
Psychosis NOS
 No more than 120 days of anti-psychotic
medication
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Taken not prescribed
Family Introduction to the
NAVIGATE Program
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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.
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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.
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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.
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Participants will learn strategies that will them support the person in NAVIGATE to
pursue his/her goals and get on with his/her life.
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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.
INTRODUCTION TO JUST THE
FACTS SESSIONS
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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 THE
FACTS SESSIONS
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· 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.