An Integrated Program for the Treatment of First Episode of Psychosis (RAISE ETP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
State University of New York - Downstate Medical Center
University of North Carolina, Chapel Hill
University of California, Los Angeles
Dartmouth-Hitchcock Medical Center
Research Foundation for Mental Hygiene, Inc.
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01321177
First received: January 27, 2011
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Brief Psychotic Disorder
Psychotic Disorder NOS
Behavioral: Integrated Treatment
Behavioral: Community Care
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Recovery After an Initial Schizophrenia Episode (RAISE): RAISE Early Treatment Program

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    This scale measures psychosocial functioning and behavior in people with schizophrenia.


Secondary Outcome Measures:
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at baseline, month 6, month 12, month 18, and month 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measures cost effectiveness of treatment conditions


Estimated Enrollment: 400
Study Start Date: July 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:

  • 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
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 :

  • medication for symptoms and preventing relapse
  • psychosocial therapy which may include a range of behavioral treatments and supportive services
  • Case management

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.

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321177

  Show 33 Study Locations
Sponsors and Collaborators
North Shore Long Island Jewish Health System
State University of New York - Downstate Medical Center
University of North Carolina, Chapel Hill
University of California, Los Angeles
Dartmouth-Hitchcock Medical Center
Research Foundation for Mental Hygiene, Inc.
Investigators
Principal Investigator: John Kane, MD Feinstein Institute for Medical Research
  More Information

No publications provided

Responsible Party: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01321177     History of Changes
Other Study ID Numbers: HHSN271200900019C, HHSN271200900019C
Study First Received: January 27, 2011
Last Updated: May 29, 2014
Health Authority: United States: Federal Government

Keywords provided by North Shore Long Island Jewish Health System:
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Brief Psychotic Disorder
Psychotic Disorder NOS
First Episode

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 20, 2014