An Integrated Program for the Treatment of First Episode of Psychosis

Schizophrenia Clinical Trial

— RAISE ETP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321177
• Other study ID #: HHSN271200900019C
• Secondary ID: HHSN271200900019
• Status: Completed
• Phase: N/A
• Start date: July 2010
• Est. completion date: July 2017

Study information

• Verified date: October 2021
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: July 2017
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Brief Psychotic Disorder
• Disease
• Mental Disorders
• Psychotic Disorder NOS
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorder

Intervention

Behavioral:
• Integrated Treatment
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
• Community Care
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

Locations

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

Sponsors (7)

Lead Sponsor	Collaborator
Northwell Health	Dartmouth-Hitchcock Medical Center, National Institute of Mental Health (NIMH), Research Foundation for Mental Hygiene, Inc., State University of New York - Downstate Medical Center, University of California, Los Angeles, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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