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Multi-disciplinary Treatment for Patients Experiencing First Episode of Psychosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01216891
Recruitment Status : Completed
First Posted : October 7, 2010
Last Update Posted : November 3, 2016
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of Maryland
New York State Office of Mental Health (OMH)
Maryland Department of Health and Mental Hygiene
Information provided by (Responsible Party):
Lisa Dixon, Research Foundation for Mental Hygiene, Inc.

Tracking Information
First Submitted Date  ICMJE October 4, 2010
First Posted Date  ICMJE October 7, 2010
Last Update Posted Date November 3, 2016
Study Start Date  ICMJE October 2010
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2015)
  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at baseline ]
    This measures occupational functioning, social functioning and symptom severity.
  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month 6 ]
  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month 12 ]
  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month 18 ]
  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month 24 ]
  • Pathways to Care Qualitative Interview [ Time Frame: Measured at baseline ]
    This assessment gathers information on help-seeking events and participant recommendations.
Original Primary Outcome Measures  ICMJE
 (submitted: October 6, 2010)
  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at baseline ]
    This measures occupational functioning, social functioning and symptom severity.
  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month 3 ]
  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month 6 ]
  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month 9 ]
  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month 12 ]
  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month15 ]
  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month 18 ]
  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month 21 ]
  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2011)
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at baseline ]
    This assesses the level of severity of illness.
  • Calgary Depression Scale [ Time Frame: Measured at baseline ]
    This assesses depression in people with schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at baseline ]
    This measures the presence and severity of symptoms of schizophrenia.
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 6 ]
    This assesses the level of severity of illness.
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 12 ]
    This assesses the level of severity of illness.
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 18 ]
    This assesses the level of severity of illness.
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 24 ]
    This assesses the level of severity of illness.
  • Calgary Depression Scale [ Time Frame: Measured at Month 6 ]
    This assesses depression in people with schizophrenia.
  • Calgary Depression Scale [ Time Frame: Measured at Month 12 ]
    This assesses depression in people with schizophrenia.
  • Calgary Depression Scale [ Time Frame: Measured at Month 18 ]
    This assesses depression in people with schizophrenia.
  • Calgary Depression Scale [ Time Frame: Measured at Month 24 ]
    This assesses depression in people with schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 6 ]
    This measures the presence and severity of symptoms of schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 12 ]
    This measures the presence and severity of symptoms of schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 18 ]
    This measures the presence and severity of symptoms of schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 24 ]
    This measures the presence and severity of symptoms of schizophrenia.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2010)
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at baseline ]
    This assesses the level of severity of illness.
  • Calgary Depression Scale [ Time Frame: Measured at baseline ]
    This assesses depression in people with schizophrenia.
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Measured at baseline ]
    This assesses suicide risk, including the content and intensity of suicidal thoughts and behaviors.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at baseline ]
    This measures the presence and severity of symptoms of schizophrenia.
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 3 ]
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 6 ]
    This assesses the level of severity of illness.
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 9 ]
    This assesses the level of severity of illness.
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 12 ]
    This assesses the level of severity of illness.
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 15 ]
    This assesses the level of severity of illness.
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 18 ]
    This assesses the level of severity of illness.
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 21 ]
    This assesses the level of severity of illness.
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 24 ]
    This assesses the level of severity of illness.
  • Calgary Depression Scale [ Time Frame: Measured at Month 3 ]
    This assesses depression in people with schizophrenia.
  • Calgary Depression Scale [ Time Frame: Measured at Month 6 ]
    This assesses depression in people with schizophrenia.
  • Calgary Depression Scale [ Time Frame: Measured at Month 9 ]
    This assesses depression in people with schizophrenia.
  • Calgary Depression Scale [ Time Frame: Measured at Month 12 ]
    This assesses depression in people with schizophrenia.
  • Calgary Depression Scale [ Time Frame: Measured at Month 15 ]
    This assesses depression in people with schizophrenia.
  • Calgary Depression Scale [ Time Frame: Measured at Month 18 ]
    This assesses depression in people with schizophrenia.
  • Calgary Depression Scale [ Time Frame: Measured at Month 21 ]
    This assesses depression in people with schizophrenia.
  • Calgary Depression Scale [ Time Frame: Measured at Month 24 ]
    This assesses depression in people with schizophrenia.
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Measured at Month 3 ]
    This assesses suicide risk, including the content and intensity of suicidal thoughts and behaviors.
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Measured at Month 6 ]
    This assesses suicide risk, including the content and intensity of suicidal thoughts and behaviors.
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Measured at Month 9 ]
    This assesses suicide risk, including the content and intensity of suicidal thoughts and behaviors.
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Measured at Month 12 ]
    This assesses suicide risk, including the content and intensity of suicidal thoughts and behaviors.
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Measured at Month 15 ]
    This assesses suicide risk, including the content and intensity of suicidal thoughts and behaviors.
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Measured at Month 18 ]
    This assesses suicide risk, including the content and intensity of suicidal thoughts and behaviors.
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Measured at Month 21 ]
    This assesses suicide risk, including the content and intensity of suicidal thoughts and behaviors.
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Measured at Month 24 ]
    This assesses suicide risk, including the content and intensity of suicidal thoughts and behaviors.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 3 ]
    This measures the presence and severity of symptoms of schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 6 ]
    This measures the presence and severity of symptoms of schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 9 ]
    This measures the presence and severity of symptoms of schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 12 ]
    This measures the presence and severity of symptoms of schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 15 ]
    This measures the presence and severity of symptoms of schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 18 ]
    This measures the presence and severity of symptoms of schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 21 ]
    This measures the presence and severity of symptoms of schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 24 ]
    This measures the presence and severity of symptoms of schizophrenia.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multi-disciplinary Treatment for Patients Experiencing First Episode of Psychosis
Official Title  ICMJE Recovery After an Initial Schizophrenia Episode (RAISE): The RAISE Connection Program Duration of Untreated Psychosis (DUP)
Brief Summary

This study will assess the effectiveness of an experimental treatment intervention for adolescents and adults who have experienced their first episode of psychosis during the past two years.

The DUP sub-study will collect pathways to care information that will be used to inform the development and pilot testing of strategies that aim to reduce DUP among individuals experiencing a first episode of psychosis.

Detailed Description

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 Connection Program, is one of the two independent research studies that NIMH has funded to conduct the NIMH RAISE Project. The Connection Program 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 Connection Program aims to to assess the effectiveness of a Team-based intervention for individuals with a first psychotic episode, observing outcomes over time for our study participants. When tracking outcomes, the Connection Program will make comparisons with what is known about the natural history of untreated first episode of psychosis as well as usual care outcomes from other experimental studies.

This study is for people who have experienced symptoms such as hallucinations, unusual thoughts or beliefs, or disorganized thinking for the first time during the past two years. Without treatment, many people have a difficult time with these symptoms, which can be very upsetting and also make it hard to socialize, study, or work.

People have different wishes and needs, and it is not clear what combination of treatments and services is best for any one person. There are many possible treatments and services, such as medications, talk therapy, case management, and school and job counseling. This study will adapt and evaluate the impact of a comprehensive and integrated treatment intervention for first episode psychosis to be delivered in real-world practice settings to promote symptomatic recovery, minimize disability, and maximize social, academic, and vocational functioning.

Participation in this study will last up to 2 years. At the baseline visit, participants will be enrolled to receive the experimental intervention. During the study period, participants will take part in research interviews every three to six months for a total of 6 interviews. Each of these research interviews will take 1.5 to 3 hours to complete. Assessments of participants' health condition, overall function and illness severity, employment status, academic performance, and social functioning will be conducted during these research interviews. In addition to assessing functioning and illness severity, this study will also address substance abuse and utilization of healthcare services. Participants will also be measured for their height, weight and waist circumference. This portion of the study concluded in December 2013.

The RAISE-DUP contract modification seeks additional information on the referral pathways that resulted in enrollment in the RAISE Connection Program from individuals who participated in RAISE Connection Program services and their family members. Information gathered through qualitative research interviews will be used to inform the development and pilot testing of outreach, education, and engagement intervention strategies, to serve the larger goal of reducing the duration of untreated psychosis among individuals experiencing a first episode of psychosis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Schizoaffective Disorder
  • Schizophreniform Disorder
  • Delusional Disorder
  • Psychosis
Intervention  ICMJE Behavioral: Multi-element, team-oriented treatment
Participants will receive treatment and services based on their needs coordinated by a small team that is led by a clinical coordinator. Services that are available to the participants include social skills training, medication treatment to address symptoms, education and employment advising, and substance use treatment.
Study Arms  ICMJE Experimental: Team-based treatment
Intervention: Behavioral: Multi-element, team-oriented treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2013)
65
Original Estimated Enrollment  ICMJE
 (submitted: October 6, 2010)
370
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age range: 15-35 years old (16-35 years old in New York)
  • Diagnosis of schizophrenia, schizoaffective and schizophreniform disorder, delusional disorder, or psychosis not otherwise specified (NOS)
  • Duration of psychotic symptoms > 1 week and < 2 years
  • Ability to provide informed consent
  • Ability to speak and understand English
  • Anticipated availability to participate in the intervention for at least 1 year
  • RAISE-DUP: participants must have been enrolled in the RAISE study

Exclusion Criteria:

  • Medical conditions which impair function independent of psychosis
  • Other diagnoses associated with psychosis:
  • Substance-induced psychotic disorder
  • Psychotic affective disorder (major depressive or manic episode with psychotic features)
  • Psychotic disorder due to a general medication condition
  • Mental retardation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01216891
Other Study ID Numbers  ICMJE RAISE Connection
HHSN271200900020C ( Other Grant/Funding Number: National Institute of Mental Health )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Lisa Dixon, Research Foundation for Mental Hygiene, Inc.
Original Responsible Party Jeffrey Lieberman, M.D., Research Foundation of Mental Hygiene
Current Study Sponsor  ICMJE Research Foundation for Mental Hygiene, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • University of Maryland
  • New York State Office of Mental Health (OMH)
  • Maryland Department of Health and Mental Hygiene
Investigators  ICMJE
Principal Investigator: Lisa Dixon, MD Columbia University
Principal Investigator: Melanie Bennett, PhD University of Maryland
PRS Account Research Foundation for Mental Hygiene, Inc.
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP