<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/NCT03291717</url>
  </required_header>
  <id_info>
    <org_study_id>4591</org_study_id>
    <nct_id>NCT03291717</nct_id>
  </id_info>
  <brief_title>Bridging Community Gaps Photovoice</brief_title>
  <acronym>BCGP</acronym>
  <official_title>Randomized Trial of a Peer-led Intervention to Promote Community Living and Participation - The Bridging Community Gaps Photovoice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University Charles River Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mental Health Center of Denver</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Connecticut State, Department of Mental Health and Addiction Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Riverside Community Care</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston University Charles River Campus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test a peer-led intervention intended to promote the&#xD;
      community living and participation of individuals with psychiatric disabilities entitled&#xD;
      &quot;Bridging Community Gaps Photovoice&quot; (BCGP). The intervention targets increasing community&#xD;
      involvement of individuals with psychiatric disabilities through reduction in self-stigma and&#xD;
      perceived stigma, enhancing opportunities for community participation, and support to achieve&#xD;
      community participation goals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The BCGP intervention is 6 months long and the investigators expect that participants will&#xD;
      experience lower self and perceived stigma, increased community participation and sense of&#xD;
      belonging, and improved psychosocial functioning and personal growth after the intervention.&#xD;
      The intervention is comprised of a 12-week class that meets once a week for two hours,&#xD;
      followed by three booster sessions - one per month in the three months following the class,&#xD;
      and up to 24 sessions of individual support as needed throughout the 6 months provided on a&#xD;
      weekly basis either in person or by phone. The purpose of the individual support is to&#xD;
      reinforce the class activities and to ensure the participants meets their community&#xD;
      participation goal. The proposed study is a randomized trial which will be conducted at&#xD;
      Boston University Center for Psychiatric Rehabilitation (BUCPR) in Massachusetts, the Mental&#xD;
      Health Center of Denver (MHCD) in Colorado, and the Greater Bridgeport Mental Health Center&#xD;
      (GBMHC) in Connecticut.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Actual">September 11, 2020</completion_date>
  <primary_completion_date type="Actual">September 11, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>UCLA Loneliness Scale</measure>
    <time_frame>Change from Baseline to 3 months to 6 months to 9 months to 12 months</time_frame>
    <description>is a 20-item 4-point Likert-type scale, widely used measure of loneliness and social isolation. Cronbach's alpha coefficients ranging from .89 to .94.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multi-Dimensional Assessment of Community Participation</measure>
    <time_frame>Change from Baseline to 3 months to 6 months to 9 months to 12 months</time_frame>
    <description>Consists of a set of objective and subjective measures of community belonging, inclusion and participation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Internalized Stigma of Mental Illness Scale</measure>
    <time_frame>Change from Baseline to 3 months to 6 months to 9 months to 12 months</time_frame>
    <description>29-item, 4-point scale from (strongly disagree to strongly agree) assesses behaviors, thoughts and feelings that are self-stigmatizing including alienation, stereotype endorsement, social withdrawal, stigma resistance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Stigma Scale</measure>
    <time_frame>Change from Baseline to 3 months, 3 months to 6 months, 6 months to 9 months, 9 months to 12 months</time_frame>
    <description>28 item, 5 point scale (strongly disagree to strongly agree) measuring experienced and anticipated stigma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Approaches to Coping with Anti-Stigma</measure>
    <time_frame>Change from Baseline to 3 months to 6 months to 9 months to 12 months</time_frame>
    <description>27-item instrument with a 4 point scale (strongly disagree to strongly agree) measuring strategies to cope with stigma: secrecy, withdrawal, educating, challenging, and distancing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Personal Growth and Recovery Scale</measure>
    <time_frame>Change from Baseline to 3 months to 6 months to 9 months to 12 months</time_frame>
    <description>25-item, 4 point scale (strongly disagree to strongly agree) of items measuring psychosocial functioning and recovery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Community Goal Achievement Scale</measure>
    <time_frame>Change from Baseline to 3 months to 6 months to 9 months to 12 months</time_frame>
    <description>adapted from Goal Attainment Scale, provides a structured approach to determining goal achievement regardless of the type or uniqueness of goal .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavior and Symptom Identification Scale (BASIS - R)</measure>
    <time_frame>Change from Baseline to 3 months to 6 months to 9 months to 12 months</time_frame>
    <description>A 24-item scale that measures: mood disturbances, anxiety, interpersonal and role functioning, daily living skills, psychotic symptoms, impulsivity and substance use</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">197</enrollment>
  <condition>Mental Illness</condition>
  <condition>Social Isolation</condition>
  <arm_group>
    <arm_group_label>Bridging Community Gaps Photovoice (BCGP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The BCGP program is a 6-month photovoice-based intervention to help individuals with psychiatric disabilities enhance their community participation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Services as Usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Individuals in this group continue with their regular mental health services with no additional intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Bridging Community Gaps Photovoice (BCGP)</intervention_name>
    <description>Participants assigned to this group will be part of the 6-month long BCGP intervention, which involves a 12- week class that meets weekly, followed by three booster sessions - one per month in the three months following the class, and up to 24 sessions of individual support as needed throughout the 6 months provided on a weekly basis either in person or by phone. The BCGP classes follow a manualized curriculum with sessions that combine didactic information, Photovoice exercises, and group discussions to empower participants in pursuing community participation goals, all refined with input from individuals with a lived experience.</description>
    <arm_group_label>Bridging Community Gaps Photovoice (BCGP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. are 18 or older.&#xD;
&#xD;
          2. are recipients of services at research sites due to having a DSM-V diagnosis of mental&#xD;
             illness, including dual diagnosis (dual diagnosis refers to co-occurring mental&#xD;
             illness and alcohol/ substance use disorder).&#xD;
&#xD;
          3. are interested in enhancing their community participation.&#xD;
&#xD;
          4. are not currently receiving individual peer support services.&#xD;
&#xD;
          5. are able to read and write in English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1)Inability to give full and knowing consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erna S Rogers, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mental Health Center of Denver</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greater Bridgeport Mental Health Center</name>
      <address>
        <city>Bridgeport</city>
        <state>Connecticut</state>
        <zip>06610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston University, Center for Psychiatric Rehabilitation</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Horizon House- Riverside Community Care</name>
      <address>
        <city>Wakefield</city>
        <state>Massachusetts</state>
        <zip>01880</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 12, 2020</last_update_submitted>
  <last_update_submitted_qc>September 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston University Charles River Campus</investigator_affiliation>
    <investigator_full_name>Erna Sally Rogers</investigator_full_name>
    <investigator_title>Research Professor</investigator_title>
  </responsible_party>
  <keyword>Mental Illness</keyword>
  <keyword>Community Participation</keyword>
  <keyword>Stigma</keyword>
  <keyword>Photovoice</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03291717
org study id: 4591
nct id: NCT03291717
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test a peer-led intervention intended to promote the
      community living and participation of individuals with psychiatric disabilities entitled
      "Bridging Community Gaps Photovoice" (BCGP). The intervention targets increasing community
      involvement of individuals with psychiatric disabilities through reduction in self-stigma and
      perceived stigma, enhancing opportunities for community participation, and support to achieve
      community participation goals.
The BCGP intervention is 6 months long and the investigators expect that participants will
      experience lower self and perceived stigma, increased community participation and sense of
      belonging, and improved psychosocial functioning and personal growth after the intervention.
      The intervention is comprised of a 12-week class that meets once a week for two hours,
      followed by three booster sessions - one per month in the three months following the class,
      and up to 24 sessions of individual support as needed throughout the 6 months provided on a
      weekly basis either in person or by phone. The purpose of the individual support is to
      reinforce the class activities and to ensure the participants meets their community
      participation goal. The proposed study is a randomized trial which will be conducted at
      Boston University Center for Psychiatric Rehabilitation (BUCPR) in Massachusetts, the Mental
      Health Center of Denver (MHCD) in Colorado, and the Greater Bridgeport Mental Health Center
      (GBMHC) in Connecticut.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: UCLA Loneliness Scale
time frame: Change from Baseline to 3 months to 6 months to 9 months to 12 months
description: is a 20-item 4-point Likert-type scale, widely used measure of loneliness and social isolation. Cronbach's alpha coefficients ranging from .89 to .94.
measure: Multi-Dimensional Assessment of Community Participation
time frame: Change from Baseline to 3 months to 6 months to 9 months to 12 months
description: Consists of a set of objective and subjective measures of community belonging, inclusion and participation.
measure: Internalized Stigma of Mental Illness Scale
time frame: Change from Baseline to 3 months to 6 months to 9 months to 12 months
description: 29-item, 4-point scale from (strongly disagree to strongly agree) assesses behaviors, thoughts and feelings that are self-stigmatizing including alienation, stereotype endorsement, social withdrawal, stigma resistance.
measure: The Stigma Scale
time frame: Change from Baseline to 3 months, 3 months to 6 months, 6 months to 9 months, 9 months to 12 months
description: 28 item, 5 point scale (strongly disagree to strongly agree) measuring experienced and anticipated stigma.
measure: Approaches to Coping with Anti-Stigma
time frame: Change from Baseline to 3 months to 6 months to 9 months to 12 months
description: 27-item instrument with a 4 point scale (strongly disagree to strongly agree) measuring strategies to cope with stigma: secrecy, withdrawal, educating, challenging, and distancing.
measure: Personal Growth and Recovery Scale
time frame: Change from Baseline to 3 months to 6 months to 9 months to 12 months
description: 25-item, 4 point scale (strongly disagree to strongly agree) of items measuring psychosocial functioning and recovery.
measure: Community Goal Achievement Scale
time frame: Change from Baseline to 3 months to 6 months to 9 months to 12 months
description: adapted from Goal Attainment Scale, provides a structured approach to determining goal achievement regardless of the type or uniqueness of goal .
measure: Behavior and Symptom Identification Scale (BASIS - R)
time frame: Change from Baseline to 3 months to 6 months to 9 months to 12 months
description: A 24-item scale that measures: mood disturbances, anxiety, interpersonal and role functioning, daily living skills, psychotic symptoms, impulsivity and substance use
arm group label: Bridging Community Gaps Photovoice (BCGP)
arm group type: Experimental
description: The BCGP program is a 6-month photovoice-based intervention to help individuals with psychiatric disabilities enhance their community participation.
arm group label: Services as Usual
arm group type: No Intervention
description: Individuals in this group continue with their regular mental health services with no additional intervention.
intervention type: Behavioral
intervention name: Bridging Community Gaps Photovoice (BCGP)
description: Participants assigned to this group will be part of the 6-month long BCGP intervention, which involves a 12- week class that meets weekly, followed by three booster sessions - one per month in the three months following the class, and up to 24 sessions of individual support as needed throughout the 6 months provided on a weekly basis either in person or by phone. The BCGP classes follow a manualized curriculum with sessions that combine didactic information, Photovoice exercises, and group discussions to empower participants in pursuing community participation goals, all refined with input from individuals with a lived experience.
arm group label: Bridging Community Gaps Photovoice (BCGP)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Erna S Rogers, PhD
role: Principal Investigator
affiliation: Boston University
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston University Charles River Campus
investigator full name: Erna Sally Rogers
investigator title: Research Professor
mesh term: Mental Disorders
sharing ipd: Undecided