An Integrated Program for the Treatment of First Episode of Psychosis

Study Overview
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Brief Summary
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The purpose of this study is to determine how services should be provided to reduce symptoms and improve life functioning for adolescents and adults who have been recently diagnosed with schizophrenia.

Detailed Description
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Schizophrenia is a major mental illness characterized by psychosis, negative symptoms (e.g., apathy, social withdrawal, anhedonia), and cognitive impairment. Depression and substance abuse commonly co-occur. These individuals have impaired functioning in the areas of work, school, parenting, self-care, independent living, interpersonal relationships, and leisure time. Among adult psychiatric disorders, schizophrenia is the most disabling, and its treatment accounts for a disproportionate share of mental health services. This study is part of the National Institute of Mental Health's Recovery After an Initial Schizophrenia Episode (RAISE) Project. The RAISE Project seeks to fundamentally change the trajectory and prognosis of schizophrenia through coordinated and aggressive treatment in the earliest stages of illness. This study, the RAISE Early Treatment Program (ETP), is one of the two independent research studies that NIMH has funded to conduct the NIMH RAISE Project. ETP is being supported in whole or in part with Federal funds from the American Recovery and Reinvestment Act of 2009 and the NIMH, National Institutes of Health, Department of Health and Human Services. The ETP study aims to compare two early treatment interventions for adolescents and adults experiencing a first episode of psychosis. The clinical centers have been randomly allocated to offer one of the two treatment programs. Both treatment interventions are designed to provide a person with treatment soon after he or she experiences the early signs of schizophrenia. Participants will be offered mental health services such as medication and psychosocial therapy. These strategies are all aimed at promoting symptom reduction and improving life functioning. Participation in this study will last between 2 and 3 years. All participants will first undergo an initial videoconference interview to confirm a diagnosis of schizophrenia, schizoaffective disorder, psychosis NOS, brief psychotic disorder, or schizophreniform disorder. Eligible participants will then be offered mental health services. In addition to the mental health services, participants will participate in a series of research interviews. Participants will be interviewed every 3 months for the first 6 months and then every 6 months for up to 3 years. At the research visit, participants will complete an interview about their symptoms and general quality of life, complete questions about experiences with their illness, their vital signs will be measured, and a blood draw will be collected. At the initial, 12 and 24 month visits, participants will also complete a brief test that assesses skills such as memory, attention and problem solving. Participants will also have monthly telephone interviews about their illness and services that they have received.

Official Title
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Recovery After an Initial Schizophrenia Episode (RAISE): RAISE Early Treatment Program

Conditions
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Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Brief Psychotic Disorder, Psychotic Disorder NOS

Intervention / Treatment
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* Behavioral: Integrated Treatment
* Behavioral: Community Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed SCID DSM-IV clinical diagnosis by trained remote clinical assessor of: schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder NOS Any duration of untreated psychosis Any ethnicity Ability to participate in research assessments in English Ability to provide fully informed consent (assent for those under age 18) Exclusion Criteria: Inability to understand what research participation entails or correctly answer the questions about research participation that are part of the Study Information Review and provide fully informed consent More than 4 months of prior cumulative treatment with antipsychotic medications Diagnosis of bipolar disorder, psychotic depression or substance-induced psychotic disorder Current psychotic disorder due to a general medical condition Current neurological disorders that would affect diagnosis or prognosis. These would include, but are not limited to seizure disorders, dementing or degenerative disorders, lesions or substantial congenital abnormalities. In most cases, disorders such as headache disorders would not require protocol exclusion Clinically significant head trauma Any other serious medical condition that in the opinion of the investigator would seriously impair functioning making the patient unsuitable for the trial

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated Treatment<br>Integrated program of treatments and services delivered by a coordinated team of providers. | Behavioral: Integrated Treatment<br>* Integrated program of treatments and services delivered by a coordinated team of providers that includes: education about schizophrenia and its treatment for the participants and their family members medication for symptoms and preventing relapse that uses a computerized decision support system strategies for managing the illness and building personal resilience help getting back to school or work using a supported employment/education model<br>|
| Active Comparator: Community Care<br>Standard mental health treatments and services offered at the local agency. | Behavioral: Community Care<br>* Standard mental health treatments and services offered at the local agency that may include : medication for symptoms and preventing relapse psychosocial therapy which may include a range of behavioral treatments and supportive services Case management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time | This scale measures psychosocial functioning and behavior in people with schizophrenia. The scale contains 21 items rated 0 (no or minimal functioning) to 6 (normal functioning). The results are reported as the total score with a range from 0 to 126. Higher scores indicate a better outcome. | Baseline, Month 6, month 12, month 18 and month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score | This measures the presence and severity of symptoms of schizophrenia. The scales contains 30 items rated 1 (absent) to 7 (extreme). The results are reported in total score with a range of 30 to 210. Higher scores indicate a worse outcome. | Measured at baseline, month 6, month 12, month 18, and month 24 | 
| Calgary Depression Scale | This scale is designed to assess depression in people with schizophrenia. The scale contains 9 items rated 0 (absent) to 3 (severe). The total score is reported and a higher value indicates a worse outcome. Total scores can range from 0 to 27. The data is reported as the estimated mean of the total score. | Measured at baseline, month 6, month 12, month 18, and month 24 | 
| Service Use Rating Form (SURF) | Measures of treatment services used | Measured at baseline and then monthly for months 1 through 24; reported as the monthly mean | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Brief Psychotic Disorder, Psychotic Disorder NOS, First Episode