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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.

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder Delusional Disorder Psychosis Behavioral: Multi-element, team-oriented treatment Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Recovery After an Initial Schizophrenia Episode (RAISE): The RAISE Connection Program Duration of Untreated Psychosis (DUP)
Study Start Date : October 2010
Actual Primary Completion Date : January 2015
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Team-based treatment 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month 6 ]
  3. The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month 12 ]
  4. The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month 18 ]
  5. The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month 24 ]
  6. Pathways to Care Qualitative Interview [ Time Frame: Measured at baseline ]
    This assessment gathers information on help-seeking events and participant recommendations.


Secondary Outcome Measures :
  1. The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at baseline ]
    This assesses the level of severity of illness.

  2. Calgary Depression Scale [ Time Frame: Measured at baseline ]
    This assesses depression in people with schizophrenia.

  3. Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at baseline ]
    This measures the presence and severity of symptoms of schizophrenia.

  4. The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 6 ]
    This assesses the level of severity of illness.

  5. The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 12 ]
    This assesses the level of severity of illness.

  6. The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 18 ]
    This assesses the level of severity of illness.

  7. The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 24 ]
    This assesses the level of severity of illness.

  8. Calgary Depression Scale [ Time Frame: Measured at Month 6 ]
    This assesses depression in people with schizophrenia.

  9. Calgary Depression Scale [ Time Frame: Measured at Month 12 ]
    This assesses depression in people with schizophrenia.

  10. Calgary Depression Scale [ Time Frame: Measured at Month 18 ]
    This assesses depression in people with schizophrenia.

  11. Calgary Depression Scale [ Time Frame: Measured at Month 24 ]
    This assesses depression in people with schizophrenia.

  12. Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 6 ]
    This measures the presence and severity of symptoms of schizophrenia.

  13. Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 12 ]
    This measures the presence and severity of symptoms of schizophrenia.

  14. Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 18 ]
    This measures the presence and severity of symptoms of schizophrenia.

  15. Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 24 ]
    This measures the presence and severity of symptoms of schizophrenia.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01216891


Locations
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United States, Maryland
University of Maryland Medical Center, Carruthers Clinic
Baltimore, Maryland, United States, 21230
United States, New York
Washington Heights Community Service Clinic
New York, New York, United States, 10032
Sponsors and Collaborators
Research Foundation for Mental Hygiene, Inc.
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
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Principal Investigator: Lisa Dixon, MD Columbia University
Principal Investigator: Melanie Bennett, PhD University of Maryland
More Information
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Additional Information:

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Responsible Party: Lisa Dixon, Director Center for Practice Innovations, Research Foundation for Mental Hygiene, Inc.
ClinicalTrials.gov Identifier: NCT01216891    
Other Study ID Numbers: RAISE Connection
HHSN271200900020C ( Other Grant/Funding Number: National Institute of Mental Health )
First Posted: October 7, 2010    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016
Keywords provided by Lisa Dixon, Research Foundation for Mental Hygiene, Inc.:
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
 Delusional Disorder
Psychosis
First episode
Additional relevant MeSH terms:
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Disease
Schizophrenia
Psychotic Disorders
Mental Disorders
Delusions
 Schizophrenia, Paranoid
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Behavioral Symptoms