NCT02242669

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
371

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 17, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

2.4 years

First QC Date

August 18, 2014

Last Update Submit

August 28, 2017

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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

Study Arms (3)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Aim 1:
  • years of age or older
  • Self-report a diagnosis of any type of mood disorder
  • Attend DBSA meetings
  • Aim 2:
  • 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:
  • years of age or older
  • Self-report a diagnosis of any type of mood disorder
  • Have never attended a DBSA meeting

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

DepressionBipolar DisorderMood Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorBipolar and Related DisordersMental Disorders

Study Officials

  • John F Kelly, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry Harvard Medical School

Study Record Dates

First Submitted

August 18, 2014

First Posted

September 17, 2014

Study Start

November 1, 2014

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

August 29, 2017

Record last verified: 2017-08

Locations