An Integrated Program for the Treatment of First Episode of Psychosis

Not Applicable

Completed

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

Interventions: Behavioral: Community Care
Behavioral: Integrated Treatment

Registration Number: NCT01321177

Lead Sponsor: Northwell Health

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 404

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Community Care	Community Care	Standard mental health treatments and services offered at the local agency.
Integrated Treatment	Integrated Treatment	Integrated program of treatments and services delivered by a coordinated team of providers.

Primary Outcome Measures

Name	Time	Method
Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time	Baseline, Month 6, month 12, month 18 and month 24	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.

Secondary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score	Measured at baseline, month 6, month 12, month 18, and month 24	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.
Calgary Depression Scale	Measured at baseline, month 6, month 12, month 18, and month 24	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.
Service Use Rating Form (SURF)	Measured at baseline and then monthly for months 1 through 24; reported as the monthly mean	Measures of treatment services used

Trial Locations

Locations (32): Clinton-Eaton-Ingham Community Mental Health Authority
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Lansing, Michigan, United States
Henderson Mental Health Center
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Fort Lauderdale, Florida, United States
Central Fulton Community Mental Health Center
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Atlanta, Georgia, United States
Lehigh Valley Hospital Mental Health Clinic
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Allentown, Pennsylvania, United States
Santa ClaritaMental Health Center
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Santa Clarita, California, United States
Howard Center
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Burlington, Vermont, United States
Life management Center of Northwest Florida
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Panama City, Florida, United States
Saint Clare's Hospital
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Denville, New Jersey, United States
Burrell Behavioral Health
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Springfield, Missouri, United States
Cobb County Community Services Board
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Austell, Georgia, United States
San Fernando Mental Health Center
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San Fernando, California, United States
Pine Belt Mental Health Clinic
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Hattiesburg, Mississippi, United States
The Providence Center
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Providence, Rhode Island, United States
South Shore Mental Health Center
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Charlestown, Rhode Island, United States
Community Alternatives
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Saint Louis, Missouri, United States
Community Mental Health Center of Lancaster County
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Lincoln, Nebraska, United States
The Mental Health Center of Greater Manchester
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Manchester, New Hampshire, United States
Greater Nashua Mental Health Center @ Community Council
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Nashua, New Hampshire, United States
Park Center
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Fort Wayne, Indiana, United States
Terrebonne Mental Health Center
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Houma, Louisiana, United States
United Services Inc.
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Willimantic, Connecticut, United States
Community Mental Health Center, Inc.
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Lawrenceburg, Indiana, United States
Touchstone Innovare
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Grand Rapids, Michigan, United States
River Parish Mental Health Center
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Laplace, Louisiana, United States
Human Development Center
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Duluth, Minnesota, United States
PeaceHealth Oregon/Lane County Behavioral Health Services
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Eugene, Oregon, United States
Mental Health Center of Denver
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Denver, Colorado, United States
Eyerly Ball
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Des Moines, Iowa, United States
North Point Health and Wellness
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Minneapolis, Minnesota, United States
UMKC School of Pharmacy
🇺🇸
Kansas City, Missouri, United States
Catholic Social Services of Washtenaw County (CSSW)
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Ann Arbor, Michigan, United States
University of New Mexico Department of Psychiatry UNM Health Sciences Center
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Albuquerque, New Mexico, United States