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Enhancing Outcomes, Reducing Costs: Evaluating Peer Support for Mood Disorders

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02242669
Collaborator
National Institute of Mental Health (NIMH) (NIH)
371
Enrollment
2
Locations
29
Duration (Months)
185.5
Patients Per Site
6.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study to evaluate peer-led mutual help organizations (MHOs) that target individuals with psychiatric diagnoses such as mood disorders, and provide evidence either supporting the expansion of such groups and the development and testing of clinical procedures, or point toward reevaluation and development of alternative low-cost, community based approaches to promoting recovery among individuals suffering from these disorders.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Participants will include up to 200 participants from The Depression and Bipolar Support Alliance (DBSA) for Aim 1. Aim 1 will measure characteristics of current DBSA members through cross-sectional surveys of demographics, clinical use history, and involvement in DBSA. 60 new DBSA members who began attending in the past month will be enrolled for Aim 2. Aim 3 will consist of 100 matched controls of people who have never attended a DBSA meeting. Assessments will be completed at McLean Hospital, in which a study staff member will thoroughly explain the study to participants. If participants are eligible for Aim 2, study staff will receive written consent from the participant.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    371 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Other
    Official Title:
    Enhancing Outcomes, Reducing Costs: Evaluating Peer Support for Mood Disorders
    Study Start Date :
    Nov 1, 2014
    Actual Primary Completion Date :
    Apr 1, 2017
    Actual Study Completion Date :
    Apr 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    AIM 1

    200 current DBSA participants.
    AIM 2

    60 new DBSA attendees with mood disorders who have attended their first meeting in the past month.
    AIM 3

    100 matched control group individuals with mood disorders with no current or prior exposure to DBSA.

    Outcome Measures

    Primary Outcome Measures

    1. Systematically gather empirical estimates of the characteristics of current DBSA participants through a cross-sectional survey of demographics, clinical service, and past and current DBSA attendance, involvement, and subjective benefits. [Up to 24 months]

      The goal is to describe and characterize DBSA participants and obtain information on subjective benefits.

    2. Provide estimates of rates of attendance, retention in, and discontinuation from DBSA for new DBSA members with mood disorders. [Up to 24 months]

      Determine which DBSA participants are more likely to attend more frequently/become more engaged.

    3. Conduct a prospective between-group investigation comparing new DBSA members to a matched control group with no prior exposure to DBSA in order to test for beneficial affects of DBSA over a 6-month follow up. [Up to 24 months]

      Compare new DBSA members to a matched control group in order to test for any potential incremental beneficial effects from DBSA participation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Aim 1:

    • 18 years of age or older

    • Self-report a diagnosis of any type of mood disorder

    • Attend DBSA meetings

    • Aim 2:

    • 18 years of age or older

    • Self-report a diagnosis of any type of mood disorder

    • Have attended their first meeting in the past month

    • Aim 3:

    • 18 years of age or older

    • Self-report a diagnosis of any type of mood disorder

    • Have never attended a DBSA meeting

    Exclusion Criteria:

    • Aim 1:

    • Do not report a diagnosis of any type of mood disorder

    • Have not attended a DBSA meeting

    • Aim 2:

    • Do not report a diagnosis of any type of mood disorder

    • Have not attended a DBSA meeting

    • Have attended their first meeting prior to a month before their assessment

    • Aim 3:

    • Do not report a diagnosis of any type of mood disorder

    • Have attended a DBSA meeting

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 McLean Hospital Belmont Massachusetts United States 02478
    2 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital
    • National Institute of Mental Health (NIMH)

    Investigators

    • Principal Investigator: John F Kelly, PhD, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    John F. Kelly, Associate Professor of Psychiatry Harvard Medical School, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT02242669
    Other Study ID Numbers:
    • 2014P000153
    • R21MH101271-02
    First Posted:
    Sep 17, 2014
    Last Update Posted:
    Aug 29, 2017
    Last Verified:
    Aug 1, 2017
    Additional relevant MeSH terms:
    Disease
    Bipolar Disorder
    Mood Disorders

    Study Results

    No Results Posted as of Aug 29, 2017