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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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