<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/NCT03231761</url>
  </required_header>
  <id_info>
    <org_study_id>146/2017</org_study_id>
    <nct_id>NCT03231761</nct_id>
  </id_info>
  <brief_title>Impact of Video Presentations on Medical Students' Attitudes Toward Mental Illness</brief_title>
  <official_title>A Randomized Controlled Trial of the Impact of Video Presentations on Medical Students' Explicit and Implicit Attitudes Toward Mental Illness in Nepal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>George Washington University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>George Washington University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a randomized controlled trial examining the impact of videos on medical students'&#xD;
      implicit and explicit attitudes and knowledge related to mental illness in Nepal. Medical&#xD;
      students are randomized to one of three conditions: (a) no video, (b) a didactic video based&#xD;
      on the mental health Gap Action Programme (mhGAP) modules for depression and psychosis; and&#xD;
      (c) videos with personal testimonials from mental health service users with depression and&#xD;
      psychosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stigma towards mental health patients exists within health systems worldwide, affecting high-&#xD;
      and low-income countries alike. Stigmatizing beliefs held by health professionals toward&#xD;
      mental illness can have detrimental health impacts on the patients. These stigmatizing&#xD;
      beliefs against mental health patients within the health system have been noted across South&#xD;
      Asia, including Nepal. Two sources of stigmatizing beliefs towards mental illness are&#xD;
      explicit (conscious) and implicit (unconscious) attitudes held by health professionals. There&#xD;
      is a dearth of research that investigates both explicit and implicit attitudes of health&#xD;
      professionals towards mental health in South Asia though. One method to reduce stigma is&#xD;
      through contact with people who suffer from mental illness. However, there is a gap in the&#xD;
      literature on low- and middle-income countries integrating contact with mental health service&#xD;
      users in health provider trainings. Forthcoming research in Nepal is exploring the causal&#xD;
      impact of service user involved mental health trainings of health professionals on explicit&#xD;
      and implicit attitudes as well as clinical care, but this research has yet to investigate the&#xD;
      effects of service user training on health professional students (in progress). Research&#xD;
      efforts on mental health trainings should be expanded to student populations to reduce&#xD;
      negative attitudes before providers enter the workforce.&#xD;
&#xD;
      The purpose of this study is to evaluate whether information-based training with or without&#xD;
      service user testimony is more effective at reducing implicit and explicit biases toward&#xD;
      mental health patients and increasing clinical care in Nepali health professional students.&#xD;
      The findings from this study will fill the gap in research that evaluates intervention&#xD;
      efficacy of reducing stigma towards mental health patients in Nepali student health&#xD;
      education. By implementing mental health trainings, the long-term goals of this intervention&#xD;
      are to reduce stigma held by health professionals against mental health patients and improve&#xD;
      clinical care in Nepal by reducing negative implicit and explicit attitudes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2017</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Social Distance Scale</measure>
    <time_frame>Immediately after presentation of experimental, active comparator, or no intervention condition (duration of experimental and active comparator conditions is 15-20 minutes)</time_frame>
    <description>Likert rating scale with items referring to level of social distance from persons with mental illness</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implicit Association Test (IAT)</measure>
    <time_frame>Immediately after presentation of experimental, active comparator, or no intervention condition (duration of experimental and active comparator conditions is 15-20 minutes)</time_frame>
    <description>Implicit Association Test for biases associating mental illness and physical illness by two attributes: violence and burdensomeness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Community Informant Detection Tool (CIDT) vignettes for diagnostic and treatment knowledge assessment</measure>
    <time_frame>Immediately after presentation of experimental, active comparator, or no intervention condition (duration of experimental and active comparator conditions is 15-20 minutes)</time_frame>
    <description>Vignettes followed by knowledge assessment (multiple choice and free response questions) to evaluate ability to correctly diagnose and recommend treatment for person with depression and psychosis, based on vignettes from CIDT used in Nepal</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Stigmatization</condition>
  <condition>Depression</condition>
  <condition>Psychosis</condition>
  <arm_group>
    <arm_group_label>Service user testimonial videos</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Videos with service user testimonials about depression and psychosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mhGAP didactic video</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The intervention in the active comparator arm includes two didactic videos with instruction about depression and psychosis based on the World Health Organization mental health Gap Action Programme (mhGAP) modules for those conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No video</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants do not observe any videos prior to the assessment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Service user testimonial videos</intervention_name>
    <description>Service users describe their personal experiences receiving care for depression or psychosis and the impact of the treatment on their quality of life</description>
    <arm_group_label>Service user testimonial videos</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>mhGAP didactic video</intervention_name>
    <description>Video with a narrated slide presentation describing diagnosis and treatment of depression and psychosis</description>
    <arm_group_label>mhGAP didactic video</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medical students in universities in Nepal&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical students are excluded if they have already completed their psychiatric&#xD;
             clinical rotation&#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>Brandon Kohrt, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>George Washington University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tribhuvan University Institute of Medicine</name>
      <address>
        <city>Maharajgunj</city>
        <state>Kathmandu</state>
        <country>Nepal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kathmandu University School of Medicine</name>
      <address>
        <city>Dhulikhel</city>
        <country>Nepal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Nepal</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>January 2, 2019</last_update_submitted>
  <last_update_submitted_qc>January 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>George Washington University</investigator_affiliation>
    <investigator_full_name>Brandon A Kohrt, MD, PhD</investigator_full_name>
    <investigator_title>Associate Professor of Psychiatry</investigator_title>
  </responsible_party>
  <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>
    <ipd_description>Upon request, the researchers will share medical student response data if approved by the principal investigator, and medical school research officials.</ipd_description>
  </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/NCT03231761
org study id: 146/2017
nct id: NCT03231761
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a randomized controlled trial examining the impact of videos on medical students'
      implicit and explicit attitudes and knowledge related to mental illness in Nepal. Medical
      students are randomized to one of three conditions: (a) no video, (b) a didactic video based
      on the mental health Gap Action Programme (mhGAP) modules for depression and psychosis; and
      (c) videos with personal testimonials from mental health service users with depression and
      psychosis.
Stigma towards mental health patients exists within health systems worldwide, affecting high-
      and low-income countries alike. Stigmatizing beliefs held by health professionals toward
      mental illness can have detrimental health impacts on the patients. These stigmatizing
      beliefs against mental health patients within the health system have been noted across South
      Asia, including Nepal. Two sources of stigmatizing beliefs towards mental illness are
      explicit (conscious) and implicit (unconscious) attitudes held by health professionals. There
      is a dearth of research that investigates both explicit and implicit attitudes of health
      professionals towards mental health in South Asia though. One method to reduce stigma is
      through contact with people who suffer from mental illness. However, there is a gap in the
      literature on low- and middle-income countries integrating contact with mental health service
      users in health provider trainings. Forthcoming research in Nepal is exploring the causal
      impact of service user involved mental health trainings of health professionals on explicit
      and implicit attitudes as well as clinical care, but this research has yet to investigate the
      effects of service user training on health professional students (in progress). Research
      efforts on mental health trainings should be expanded to student populations to reduce
      negative attitudes before providers enter the workforce.

      The purpose of this study is to evaluate whether information-based training with or without
      service user testimony is more effective at reducing implicit and explicit biases toward
      mental health patients and increasing clinical care in Nepali health professional students.
      The findings from this study will fill the gap in research that evaluates intervention
      efficacy of reducing stigma towards mental health patients in Nepali student health
      education. By implementing mental health trainings, the long-term goals of this intervention
      are to reduce stigma held by health professionals against mental health patients and improve
      clinical care in Nepal by reducing negative implicit and explicit attitudes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Social Distance Scale
time frame: Immediately after presentation of experimental, active comparator, or no intervention condition (duration of experimental and active comparator conditions is 15-20 minutes)
description: Likert rating scale with items referring to level of social distance from persons with mental illness
measure: Implicit Association Test (IAT)
time frame: Immediately after presentation of experimental, active comparator, or no intervention condition (duration of experimental and active comparator conditions is 15-20 minutes)
description: Implicit Association Test for biases associating mental illness and physical illness by two attributes: violence and burdensomeness
measure: Modified Community Informant Detection Tool (CIDT) vignettes for diagnostic and treatment knowledge assessment
time frame: Immediately after presentation of experimental, active comparator, or no intervention condition (duration of experimental and active comparator conditions is 15-20 minutes)
description: Vignettes followed by knowledge assessment (multiple choice and free response questions) to evaluate ability to correctly diagnose and recommend treatment for person with depression and psychosis, based on vignettes from CIDT used in Nepal
arm group label: Service user testimonial videos
arm group type: Experimental
description: Videos with service user testimonials about depression and psychosis
arm group label: mhGAP didactic video
arm group type: Active Comparator
description: The intervention in the active comparator arm includes two didactic videos with instruction about depression and psychosis based on the World Health Organization mental health Gap Action Programme (mhGAP) modules for those conditions
arm group label: No video
arm group type: No Intervention
description: Participants do not observe any videos prior to the assessment
intervention type: Other
intervention name: Service user testimonial videos
description: Service users describe their personal experiences receiving care for depression or psychosis and the impact of the treatment on their quality of life
arm group label: Service user testimonial videos
intervention type: Other
intervention name: mhGAP didactic video
description: Video with a narrated slide presentation describing diagnosis and treatment of depression and psychosis
arm group label: mhGAP didactic video
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Brandon Kohrt, MD, PhD
role: Principal Investigator
affiliation: George Washington University
facility: 
facility: 
country: Nepal
responsible party type: Principal Investigator
investigator affiliation: George Washington University
investigator full name: Brandon A Kohrt, MD, PhD
investigator title: Associate Professor of Psychiatry
mesh term: Mental Disorders
sharing ipd: Undecided
ipd description: Upon request, the researchers will share medical student response data if approved by the principal investigator, and medical school research officials.