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

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ClinicalTrials.gov Identifier: NCT02242669
Recruitment Status : Completed
First Posted : September 17, 2014
Last Update Posted : August 29, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
John F. Kelly, Massachusetts General Hospital

Study Description
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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.

Condition or disease
Depression Bipolar Disorders Mood Disorders

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 Design
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Study Type : Observational
Actual Enrollment : 371 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Enhancing Outcomes, Reducing Costs: Evaluating Peer Support for Mood Disorders
Study Start Date : November 2014
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mood Disorders

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02242669


Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: John F Kelly, PhD Massachusetts General Hospital
More Information
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Responsible Party: John F. Kelly, Associate Professor of Psychiatry Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02242669     History of Changes
Other Study ID Numbers: 2014P000153
R21MH101271-02 ( U.S. NIH Grant/Contract )
First Posted: September 17, 2014    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Mood Disorders
 Pathologic Processes
Bipolar and Related Disorders
Mental Disorders