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

NCT ID: NCT02242669

Last Updated: 2017-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

371 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression Bipolar Disorders Mood Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AIM 1

200 current DBSA participants.

No interventions assigned to this group

AIM 2

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

No interventions assigned to this group

AIM 3

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

John F. Kelly

Associate Professor of Psychiatry Harvard Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John F Kelly, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

McLean Hospital

Belmont, Massachusetts, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R21MH101271-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2014P000153

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mechanisms of Action and Outcome
NCT00555568 COMPLETED NA
Mood and Thought Process Study
NCT05585775 RECRUITING NA