Clinical Trial: Multi-disciplinary Treatment for Patients Experiencing First Episode of Psychosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:

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 setti
Sponsor: Research Foundation for Mental Hygiene, Inc.

Current Primary Outcome:

  • 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:

  • 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 ]


Current Secondary Outcome:

  • 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:

  • 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 ]