<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02242669</url>
  </required_header>
  <id_info>
    <org_study_id>2014P000153</org_study_id>
    <secondary_id>R21MH101271-02</secondary_id>
    <nct_id>NCT02242669</nct_id>
  </id_info>
  <brief_title>Enhancing Outcomes, Reducing Costs: Evaluating Peer Support for Mood Disorders</brief_title>
  <official_title>Enhancing Outcomes, Reducing Costs: Evaluating Peer Support for Mood Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study to evaluate peer-led mutual help organizations (MHOs) that target&#xD;
      individuals with psychiatric diagnoses such as mood disorders, and provide evidence either&#xD;
      supporting the expansion of such groups and the development and testing of clinical&#xD;
      procedures, or point toward reevaluation and development of alternative low-cost, community&#xD;
      based approaches to promoting recovery among individuals suffering from these disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will include up to 200 participants from The Depression and Bipolar Support&#xD;
      Alliance (DBSA) for Aim 1. Aim 1 will measure characteristics of current DBSA members through&#xD;
      cross-sectional surveys of demographics, clinical use history, and involvement in DBSA. 60&#xD;
      new DBSA members who began attending in the past month will be enrolled for Aim 2. Aim 3 will&#xD;
      consist of 100 matched controls of people who have never attended a DBSA meeting. Assessments&#xD;
      will be completed at McLean Hospital, in which a study staff member will thoroughly explain&#xD;
      the study to participants. If participants are eligible for Aim 2, study staff will receive&#xD;
      written consent from the participant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>The goal is to describe and characterize DBSA participants and obtain information on subjective benefits.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Provide estimates of rates of attendance, retention in, and discontinuation from DBSA for new DBSA members with mood disorders.</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Determine which DBSA participants are more likely to attend more frequently/become more engaged.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Compare new DBSA members to a matched control group in order to test for any potential incremental beneficial effects from DBSA participation.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">371</enrollment>
  <condition>Depression</condition>
  <condition>Bipolar Disorders</condition>
  <condition>Mood Disorders</condition>
  <arm_group>
    <arm_group_label>AIM 1</arm_group_label>
    <description>200 current DBSA participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AIM 2</arm_group_label>
    <description>60 new DBSA attendees with mood disorders who have attended their first meeting in the past month.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AIM 3</arm_group_label>
    <description>100 matched control group individuals with mood disorders with no current or prior exposure to DBSA.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        We will recruit participants from a large DBSA chapter at McLean Hospital. Subjects will be&#xD;
        recruited at the beginning of the weekly meetings, through flyers, the DBSA website, and&#xD;
        word of mouth. 200 current DBSA members and 60 new DBSA members will be assessed for Aims 1&#xD;
        and 2, respectively. 100 people who have never attended a DBSA will be assessed for Aim 3&#xD;
        and will be recruited from MGH and McLean Hospitals through the use of flyers, clinic&#xD;
        announcements, and via our online clinical and research infrastructures. Participants in&#xD;
        all Aims must be 18 years or older and self-report a diagnosis of any type of mood&#xD;
        disorder. For Aims 1 and 2, participants must have attended at least one DBSA meeting.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aim 1:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Self-report a diagnosis of any type of mood disorder&#xD;
&#xD;
          -  Attend DBSA meetings&#xD;
&#xD;
          -  Aim 2:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Self-report a diagnosis of any type of mood disorder&#xD;
&#xD;
          -  Have attended their first meeting in the past month&#xD;
&#xD;
          -  Aim 3:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Self-report a diagnosis of any type of mood disorder&#xD;
&#xD;
          -  Have never attended a DBSA meeting&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aim 1:&#xD;
&#xD;
          -  Do not report a diagnosis of any type of mood disorder&#xD;
&#xD;
          -  Have not attended a DBSA meeting&#xD;
&#xD;
          -  Aim 2:&#xD;
&#xD;
          -  Do not report a diagnosis of any type of mood disorder&#xD;
&#xD;
          -  Have not attended a DBSA meeting&#xD;
&#xD;
          -  Have attended their first meeting prior to a month before their assessment&#xD;
&#xD;
          -  Aim 3:&#xD;
&#xD;
          -  Do not report a diagnosis of any type of mood disorder&#xD;
&#xD;
          -  Have attended a DBSA meeting&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John F Kelly, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McLean Hospital</name>
      <address>
        <city>Belmont</city>
        <state>Massachusetts</state>
        <zip>02478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>John F. Kelly</investigator_full_name>
    <investigator_title>Associate Professor of Psychiatry Harvard Medical School</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bipolar Disorder</mesh_term>
    <mesh_term>Mood Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02242669
org study id: 2014P000153
secondary id: R21MH101271-02
nct id: NCT02242669
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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.
observational model: Case-Control
time perspective: Other
measure: 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
description: The goal is to describe and characterize DBSA participants and obtain information on subjective benefits.
measure: 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
description: Determine which DBSA participants are more likely to attend more frequently/become more engaged.
measure: 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
description: Compare new DBSA members to a matched control group in order to test for any potential incremental beneficial effects from DBSA participation.
arm group label: AIM 1
description: 200 current DBSA participants.
arm group label: AIM 2
description: 60 new DBSA attendees with mood disorders who have attended their first meeting in the past month.
arm group label: AIM 3
description: 100 matched control group individuals with mood disorders with no current or prior exposure to DBSA.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: John F Kelly, PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: John F. Kelly
investigator title: Associate Professor of Psychiatry Harvard Medical School
mesh term: Bipolar Disorder
mesh term: Mood Disorders