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

August 28, 2017 updated by: John F. Kelly, Massachusetts General Hospital
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.

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

371

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • Mclean Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We will recruit participants from a large DBSA chapter at McLean Hospital. Subjects will be recruited at the beginning of the weekly meetings, through flyers, the DBSA website, and word of mouth. 200 current DBSA members and 60 new DBSA members will be assessed for Aims 1 and 2, respectively. 100 people who have never attended a DBSA will be assessed for Aim 3 and will be recruited from MGH and McLean Hospitals through the use of flyers, clinic announcements, and via our online clinical and research infrastructures. Participants in all Aims must be 18 years or older and self-report a diagnosis of any type of mood disorder. For Aims 1 and 2, participants must have attended at least one DBSA meeting.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Up to 24 months
The goal is to describe and characterize DBSA participants and obtain information on subjective benefits.
Up to 24 months
Provide estimates of rates of attendance, retention in, and discontinuation from DBSA for new DBSA members with mood disorders.
Time Frame: Up to 24 months
Determine which DBSA participants are more likely to attend more frequently/become more engaged.
Up to 24 months
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.
Time Frame: 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.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

August 18, 2014

First Submitted That Met QC Criteria

September 15, 2014

First Posted (Estimate)

September 17, 2014

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2014P000153
  • R21MH101271-02 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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