xml: <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/NCT06000059</url>
    </required_header>
    <id_info>
      <org_study_id>2000034605</org_study_id>
      <nct_id>NCT06000059</nct_id>
    </id_info>
    <brief_title>Mental Health Stigma in Rural Uganda</brief_title>
    <official_title>Mental Health Stigma in Rural Uganda</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yale University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Empowerment to Heal - Uganda</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Yale University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The investigators aim to elucidate attitudes and stigma towards mental illness in the&#xD;
        pathways to mental healthcare among key stakeholders, such as traditional healers, religious&#xD;
        leaders, families of those with mental illness, and those with mental illness. Additionally,&#xD;
        the investigators hope to convert the previously conducted theater intervention to a radio&#xD;
        production, which is the most commonly used form of media in Uganda, and test its&#xD;
        effectiveness for changing attitudes and reducing stigma towards mental illness throughout&#xD;
        society.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The scientific objective of this protocol is to develop and evaluate a novel intervention to&#xD;
        reduce mental illness stigma among people in rural Uganda. The central hypothesis to be&#xD;
        assessed is that a community-designed radio-based intervention can decrease mental illness&#xD;
        stigma and lead to improved health-seeking behaviors. This hypothesis is supported by&#xD;
        preliminary data demonstrating for the first time, to our knowledge, the effectiveness of an&#xD;
        arts intervention to reduce mental health stigma in the general population in a rural region&#xD;
        of a low income country. The investigators drew on message design theory underpinned by an&#xD;
        audience-channel-message-evaluation (ACME) framework to design the intervention, a&#xD;
        community-led theater performance in collaboration with community health workers in the rural&#xD;
        Busoga Region of Eastern Uganda.&#xD;
  &#xD;
        Radio is also popular in Uganda, with 78% of all Ugandans in rural and urban areas alike&#xD;
        report listening to the radio. Listening to the radio is often a social activity. Adapting&#xD;
        the ACME framework, the investigator will work with the community to convert their previously&#xD;
        tested theater intervention into a radio intervention that can be deployed at scale.&#xD;
  &#xD;
        Aim 1: Develop a radio drama derived from our previous theater intervention designed to&#xD;
        decrease community stigma towards mental illness and increase healthcare seeking behaviors&#xD;
        among those with mental illness.&#xD;
  &#xD;
        Aim 2: Utilize qualitative methods, such as focus groups and in-depth interviews, to explore&#xD;
        local responses to the radio drama and aspects fostering its acceptance or rejection.&#xD;
  &#xD;
        Aim 3: Use a cluster randomized control trial to test the effectiveness of the radio drama in&#xD;
        decreasing mental illness stigma immediately post-intervention and at one-month follow-up.&#xD;
  &#xD;
        Hypothesis: Participants randomized to the radio drama intervention will show lower levels of&#xD;
        mental illness stigma, compared with the control group.&#xD;
  &#xD;
        The focus of this registration is Aim 3.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 10, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Broad Acceptance Scale (BAS)</measure>
      <time_frame>baseline and 1 month post intervention, an average of 2 months</time_frame>
      <description>The BAS is a 10-item questionnaire targeted to structural stigma, the &quot;societal-level conditions, cultural norms, and institutional practices that constrain the opportunities, resources, and wellbeing&quot; for individuals with mental illness. Each yes adds one point to the scale, and five questions from each scale were reverse-scored to match the direction of the scale. There were ten questions, therefore it generated a score between zero and ten. Higher scores indicated more acceptance and less stigma towards mental illness, while lower scores indicated less acceptance and more stigma towards mental illness.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Personal Acceptance Scale (PAS)</measure>
      <time_frame>baseline and 1 month post intervention, an average of 2 months</time_frame>
      <description>The PAS is a 9-item questionnaire targeted to public stigma, the &quot;negative attitudes, beliefs, and behaviors held within a community&quot; against individuals with mental illness. Each yes adds one point to the scale, and five questions from each scale were reverse-scored to match the direction of the scale. The total number of points was divided by the number of questions (nine) and multiplied by ten to generate numbers between zero and ten for comparison purposes to the Broad Acceptance Scale. Higher scores indicated more acceptance and less stigma towards mental illness, while lower scores indicated less acceptance and more stigma towards mental illness.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">350</enrollment>
    <condition>Mental Health Issue</condition>
    <arm_group>
      <arm_group_label>Radio Drama</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in this group will participate in three listening sessions. The first and third listening sessions will consist of information unrelated to mental illness. The second listening session will be the radio theater intervention that is being developed.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants in this group will participate in three listening sessions all unrelated to mental illness.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Radio Drama</intervention_name>
      <description>An hour long radio drama adapted from from a previous community-led theater intervention</description>
      <arm_group_label>Radio Drama</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participant must be willing to fully participate in the study, which will include&#xD;
               three separate listening sessions and two structured questionnaires.&#xD;
  &#xD;
            -  All members must reside in the village where the intervention is being conducted.&#xD;
  &#xD;
            -  Individuals must be able to provide written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those who cannot or are not able to willingly give consent to participate in this&#xD;
               study will be excluded.&#xD;
  &#xD;
            -  Individuals who already have a family member participating in the study&#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>Yang Jae Lee, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Yale University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yang Jae Lee, MD</last_name>
      <phone>706-691-9813</phone>
      <email>yangjae.lee@yale.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Empowerment to Heal - Uganda</name>
        <address>
          <city>Mpunde</city>
          <state>Buyende District</state>
          <country>Uganda</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Uganda</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06000059
  org study id: 2000034605
  nct id: NCT06000059
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The investigators aim to elucidate attitudes and stigma towards mental illness in the
        pathways to mental healthcare among key stakeholders, such as traditional healers, religious
        leaders, families of those with mental illness, and those with mental illness. Additionally,
        the investigators hope to convert the previously conducted theater intervention to a radio
        production, which is the most commonly used form of media in Uganda, and test its
        effectiveness for changing attitudes and reducing stigma towards mental illness throughout
        society.
  The scientific objective of this protocol is to develop and evaluate a novel intervention to
        reduce mental illness stigma among people in rural Uganda. The central hypothesis to be
        assessed is that a community-designed radio-based intervention can decrease mental illness
        stigma and lead to improved health-seeking behaviors. This hypothesis is supported by
        preliminary data demonstrating for the first time, to our knowledge, the effectiveness of an
        arts intervention to reduce mental health stigma in the general population in a rural region
        of a low income country. The investigators drew on message design theory underpinned by an
        audience-channel-message-evaluation (ACME) framework to design the intervention, a
        community-led theater performance in collaboration with community health workers in the rural
        Busoga Region of Eastern Uganda.
  
        Radio is also popular in Uganda, with 78% of all Ugandans in rural and urban areas alike
        report listening to the radio. Listening to the radio is often a social activity. Adapting
        the ACME framework, the investigator will work with the community to convert their previously
        tested theater intervention into a radio intervention that can be deployed at scale.
  
        Aim 1: Develop a radio drama derived from our previous theater intervention designed to
        decrease community stigma towards mental illness and increase healthcare seeking behaviors
        among those with mental illness.
  
        Aim 2: Utilize qualitative methods, such as focus groups and in-depth interviews, to explore
        local responses to the radio drama and aspects fostering its acceptance or rejection.
  
        Aim 3: Use a cluster randomized control trial to test the effectiveness of the radio drama in
        decreasing mental illness stigma immediately post-intervention and at one-month follow-up.
  
        Hypothesis: Participants randomized to the radio drama intervention will show lower levels of
        mental illness stigma, compared with the control group.
  
        The focus of this registration is Aim 3.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Change in Broad Acceptance Scale (BAS)
  time frame: baseline and 1 month post intervention, an average of 2 months
  description: The BAS is a 10-item questionnaire targeted to structural stigma, the "societal-level conditions, cultural norms, and institutional practices that constrain the opportunities, resources, and wellbeing" for individuals with mental illness. Each yes adds one point to the scale, and five questions from each scale were reverse-scored to match the direction of the scale. There were ten questions, therefore it generated a score between zero and ten. Higher scores indicated more acceptance and less stigma towards mental illness, while lower scores indicated less acceptance and more stigma towards mental illness.
  measure: Change in Personal Acceptance Scale (PAS)
  time frame: baseline and 1 month post intervention, an average of 2 months
  description: The PAS is a 9-item questionnaire targeted to public stigma, the "negative attitudes, beliefs, and behaviors held within a community" against individuals with mental illness. Each yes adds one point to the scale, and five questions from each scale were reverse-scored to match the direction of the scale. The total number of points was divided by the number of questions (nine) and multiplied by ten to generate numbers between zero and ten for comparison purposes to the Broad Acceptance Scale. Higher scores indicated more acceptance and less stigma towards mental illness, while lower scores indicated less acceptance and more stigma towards mental illness.
  arm group label: Radio Drama
  arm group type: Experimental
  description: Participants in this group will participate in three listening sessions. The first and third listening sessions will consist of information unrelated to mental illness. The second listening session will be the radio theater intervention that is being developed.
  arm group label: Control
  arm group type: No Intervention
  description: Participants in this group will participate in three listening sessions all unrelated to mental illness.
  intervention type: Behavioral
  intervention name: Radio Drama
  description: An hour long radio drama adapted from from a previous community-led theater intervention
  arm group label: Radio Drama
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yang Jae Lee, MD
  role: Principal Investigator
  affiliation: Yale University
  last name: Yang Jae Lee, MD
  phone: 706-691-9813
  email: yangjae.lee@yale.edu
  facility: 
  status: Recruiting
  country: Uganda
  responsible party type: Sponsor