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Trial record 2 of 1536 for:    Enhancing Outcomes

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

Tracking Information
First Submitted Date August 18, 2014
First Posted Date September 17, 2014
Last Update Posted Date August 29, 2017
Study Start Date November 2014
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 15, 2014)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Enhancing Outcomes, Reducing Costs: Evaluating Peer Support for Mood Disorders
Official Title Enhancing Outcomes, Reducing Costs: Evaluating Peer Support for Mood Disorders
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.
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
Study Design Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Depression
  • Bipolar Disorders
  • Mood Disorders
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 28, 2017)
371
Original Estimated Enrollment
 (submitted: September 15, 2014)
360
Actual Study Completion Date April 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02242669
Other Study ID Numbers 2014P000153
R21MH101271-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party John F. Kelly, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: John F Kelly, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date August 2017