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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02242669
Other study ID # 2014P000153
Secondary ID R21MH101271-02
Status Completed
Phase N/A
First received August 18, 2014
Last updated August 28, 2017
Start date November 2014
Est. completion date April 2017

Study information

Verified date August 2017
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 371
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
United States McLean Hospital Belmont Massachusetts
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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