An Integrated Program for the Treatment of First Episode of Psychosis (RAISE ETP)
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|ClinicalTrials.gov Identifier: NCT01321177|
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : September 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder Schizophreniform Disorder Brief Psychotic Disorder Psychotic Disorder NOS||Behavioral: Integrated Treatment Behavioral: Community Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||404 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Recovery After an Initial Schizophrenia Episode (RAISE): RAISE Early Treatment Program|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2017|
Experimental: Integrated Treatment
Integrated program of treatments and services delivered by a coordinated team of providers.
Behavioral: Integrated Treatment
Integrated program of treatments and services delivered by a coordinated team of providers that includes:
Active Comparator: Community Care
Standard mental health treatments and services offered at the local agency.
Behavioral: Community Care
Standard mental health treatments and services offered at the local agency that may include :
- Change from baseline on the Heinrichs-Carpenter Quality of Life Scale from Baseline [ Time Frame: Baseline, Month 6, month 12, month 18 and month 24 ]This scale measures psychosocial functioning and behavior in people with schizophrenia.
- Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at baseline, month 6, month 12, month 18, and month 24 ]This measures the presence and severity of symptoms of schizophrenia.
- Calgary Depression Scale [ Time Frame: Measured at baseline, month 6, month 12, month 18, and month 24 ]This scale is designed to assess depression in people with schizophrenia.
- Service Use Rating Form (SURF) [ Time Frame: Measured at baseline and then monthly for months 1 through 24 ]Measures cost effectiveness of treatment conditions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321177
|Principal Investigator:||John Kane, MD||Feinstein Institute for Medical Research|