- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02242669
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
Conditions
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
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Massachusetts
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Belmont, Massachusetts, United States, 02478
- Mclean Hospital
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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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 |
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AIM 1
200 current DBSA participants.
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AIM 2
60 new DBSA attendees with mood disorders who have attended their first meeting in the past month.
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AIM 3
100 matched control group individuals with mood disorders with no current or prior exposure to DBSA.
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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
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The goal is to describe and characterize DBSA participants and obtain information on subjective benefits.
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Up to 24 months
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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
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Determine which DBSA participants are more likely to attend more frequently/become more engaged.
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Up to 24 months
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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
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Compare new DBSA members to a matched control group in order to test for any potential incremental beneficial effects from DBSA participation.
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Up to 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
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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