<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/NCT04480021</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00010415</org_study_id>
    <nct_id>NCT04480021</nct_id>
  </id_info>
  <brief_title>Mobile Mental Health in Community-Based Organizations</brief_title>
  <acronym>MITHRA</acronym>
  <official_title>Mobile Mental Health in Community-Based Organizations: A Stepped Care Approach to Women's Mental Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Washington</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>
      Untreated depression is a significant cause of morbidity and mortality among women in low and&#xD;
      middle- income countries (LMIC). The investigators propose to develop and test the&#xD;
      feasibility an interactive voice-response, mobile health application (MITHRA) for screening,&#xD;
      tracking symptom severity and supporting stepped treatment of depression among women in rural&#xD;
      India. The study will lead to the development of a scalable mobile application applicable to&#xD;
      other low resource settings, and build research capacity at the India site.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Undiagnosed and untreated depression is a significant cause of morbidity and mortality in&#xD;
      low-, middle-income countries (LMIC) such as India. The rates of diagnosis and treatment of&#xD;
      depression among women in rural India are disproportionately low despite a primary care based&#xD;
      task-sharing model of mentalhealth treatment. Stepped care approaches support appropriate&#xD;
      treatment of symptoms while reducing the burden on healthcare systems and mobile technology&#xD;
      can reduce the mental health treatment gap given its reach and easy access. However, our&#xD;
      preliminary study at a task-sharing care model in rural south India revealed that illiteracy&#xD;
      and the practice of sharing mobile phones as a family resource present hurdles to the&#xD;
      adoption of mobile mental health (mHealth) based interventions. To date, the feasibility of a&#xD;
      community based multiple user mHealth application to screen depression, track symptom&#xD;
      severity and support the delivery of stepped care treatment has not been tested in LMIC.&#xD;
&#xD;
      Specific Aim 1: In phase I of this exploratory study, the investigators will adopt a user&#xD;
      centered participatory approach to design and develop a multiple-user, voice-response, mobile&#xD;
      application (&quot;MITHRA&quot;), to be used in communitybased organizations for screening, tracking&#xD;
      and supporting stepped care treatment for depression, including select modules of the Healthy&#xD;
      Activity Program, a brief psychological intervention based on behavioral activation. The&#xD;
      application will include audio, video and enhanced touchscreen capabilities, to overcome the&#xD;
      barrier of illiteracy and lack of access.&#xD;
&#xD;
      Specific Aim 2: In phase II, using a randomized-control design, the investigators will&#xD;
      examine feasibility and utility of &quot;MITHRA&quot; deployed at community-based organizations (n=3)&#xD;
      vs enhanced usual care (n=3) in communitybased organizations (enrolling approximately 60&#xD;
      women).&#xD;
&#xD;
      Specific aim 3: Throughout the duration of the funding period the investigators will arrange&#xD;
      for mentored participation of Psychiatry and Community Medicine residents from India in the&#xD;
      research project with involvement in the entire spectrum of research activities from&#xD;
      interview development and conduct to qualitative and quantitative data analysis and&#xD;
      manuscript writing and dissemination. This mentored participation will be supported by&#xD;
      regular videoconferenced didactic and case presentation sessions on research methodology.&#xD;
&#xD;
      The grant will accomplish the goals of developing a unique mobile application that is&#xD;
      scalable, examining its feasibility and building research capacity at the research site in&#xD;
      India.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2021</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Anticipated">April 2022</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>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Usage rates</measure>
    <time_frame>Baseline</time_frame>
    <description>We will obtain data on women's rates of use of the MITHRA app - this data will be obtained from the app, enabled by the single user sign on.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Usage rates</measure>
    <time_frame>3 months</time_frame>
    <description>We will obtain data on women's rates of use of the MITHRA app - this data will be obtained from the app, enabled by the single user sign on.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Change from baseline depression score (QIDS SR) at 3 months</time_frame>
    <description>Change in Quick Inventory of Depressive Symptomatology Self Report (QIDS SR - a self report tool used to measure symptoms of depression) which will be collected by a blinded / masked research assistant. Research assessments will be conducted over the phone or in the Primary Health Center to avoid unblinding of CBO randomization status (presence of tablets in the CBOs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Change from baseline depression score (QIDS SR) at 6 months</time_frame>
    <description>Change in Quick Inventory of Depressive Symptomatology Self Report (QIDS SR - a self report tool used to measure symptoms of depression) which will be collected by a blinded / masked research assistant. Research assessments will be conducted over the phone or in the Primary Health Center to avoid unblinding of CBO randomization status (presence of tablets in the CBOs)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Multiuser Interactive Health Response Application (MITHRA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomization is at the level of the Community Based Organization (CBO). CBOs randomized to MITHRA will have access to the MITHRA app on tablets. MITHRA app will include depression screening and behavioral activation modules.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Usual Care (EUC)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>CBOs randomized to EUC will receive standardized monthly group education (45 min) regarding the symptoms of depression</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MITHRA</intervention_name>
    <description>A mobile based application (app) in CBOs to screen, track and treat mild to moderate depression among low income women using Healthy Activity Program (HAP),a WHO-recommended evidence-based intervention.</description>
    <arm_group_label>Multiuser Interactive Health Response Application (MITHRA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>EUC</intervention_name>
    <description>Group education on depression by community health workers</description>
    <arm_group_label>Enhanced Usual Care (EUC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Resident of the village (i.e. not a guest attendee)&#xD;
&#xD;
          -  Plans to attend CBO meetings regularly.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with severe mental illness such as bipolar disorder or schizophrenia&#xD;
             (measured by self report / socio demographic questionnaire)&#xD;
&#xD;
          -  Suicide attempt or severe alcohol or substance use in the past 6 months (measured by&#xD;
             self report / socio demographic questionnaire)&#xD;
&#xD;
          -  Unable to participate in informed consent discussion&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amritha S Bhat, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amritha S Bhat, MD, MPH</last_name>
    <phone>206-543-3117</phone>
    <email>amritha@uw.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Natalie Franz, MPH</last_name>
    <email>nfranz@uw.edu</email>
  </overall_contact_backup>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Amritha Subray Bhat</investigator_full_name>
    <investigator_title>Assistant Professor, Psychiatry</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</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/NCT04480021
org study id: STUDY00010415
nct id: NCT04480021
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Untreated depression is a significant cause of morbidity and mortality among women in low and
      middle- income countries (LMIC). The investigators propose to develop and test the
      feasibility an interactive voice-response, mobile health application (MITHRA) for screening,
      tracking symptom severity and supporting stepped treatment of depression among women in rural
      India. The study will lead to the development of a scalable mobile application applicable to
      other low resource settings, and build research capacity at the India site.
Undiagnosed and untreated depression is a significant cause of morbidity and mortality in
      low-, middle-income countries (LMIC) such as India. The rates of diagnosis and treatment of
      depression among women in rural India are disproportionately low despite a primary care based
      task-sharing model of mentalhealth treatment. Stepped care approaches support appropriate
      treatment of symptoms while reducing the burden on healthcare systems and mobile technology
      can reduce the mental health treatment gap given its reach and easy access. However, our
      preliminary study at a task-sharing care model in rural south India revealed that illiteracy
      and the practice of sharing mobile phones as a family resource present hurdles to the
      adoption of mobile mental health (mHealth) based interventions. To date, the feasibility of a
      community based multiple user mHealth application to screen depression, track symptom
      severity and support the delivery of stepped care treatment has not been tested in LMIC.

      Specific Aim 1: In phase I of this exploratory study, the investigators will adopt a user
      centered participatory approach to design and develop a multiple-user, voice-response, mobile
      application ("MITHRA"), to be used in communitybased organizations for screening, tracking
      and supporting stepped care treatment for depression, including select modules of the Healthy
      Activity Program, a brief psychological intervention based on behavioral activation. The
      application will include audio, video and enhanced touchscreen capabilities, to overcome the
      barrier of illiteracy and lack of access.

      Specific Aim 2: In phase II, using a randomized-control design, the investigators will
      examine feasibility and utility of "MITHRA" deployed at community-based organizations (n=3)
      vs enhanced usual care (n=3) in communitybased organizations (enrolling approximately 60
      women).

      Specific aim 3: Throughout the duration of the funding period the investigators will arrange
      for mentored participation of Psychiatry and Community Medicine residents from India in the
      research project with involvement in the entire spectrum of research activities from
      interview development and conduct to qualitative and quantitative data analysis and
      manuscript writing and dissemination. This mentored participation will be supported by
      regular videoconferenced didactic and case presentation sessions on research methodology.

      The grant will accomplish the goals of developing a unique mobile application that is
      scalable, examining its feasibility and building research capacity at the research site in
      India.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Usage rates
time frame: Baseline
description: We will obtain data on women's rates of use of the MITHRA app - this data will be obtained from the app, enabled by the single user sign on.
measure: Usage rates
time frame: 3 months
description: We will obtain data on women's rates of use of the MITHRA app - this data will be obtained from the app, enabled by the single user sign on.
measure: Depression
time frame: Change from baseline depression score (QIDS SR) at 3 months
description: Change in Quick Inventory of Depressive Symptomatology Self Report (QIDS SR - a self report tool used to measure symptoms of depression) which will be collected by a blinded / masked research assistant. Research assessments will be conducted over the phone or in the Primary Health Center to avoid unblinding of CBO randomization status (presence of tablets in the CBOs)
measure: Depression
time frame: Change from baseline depression score (QIDS SR) at 6 months
description: Change in Quick Inventory of Depressive Symptomatology Self Report (QIDS SR - a self report tool used to measure symptoms of depression) which will be collected by a blinded / masked research assistant. Research assessments will be conducted over the phone or in the Primary Health Center to avoid unblinding of CBO randomization status (presence of tablets in the CBOs)
arm group label: Multiuser Interactive Health Response Application (MITHRA)
arm group type: Experimental
description: Randomization is at the level of the Community Based Organization (CBO). CBOs randomized to MITHRA will have access to the MITHRA app on tablets. MITHRA app will include depression screening and behavioral activation modules.
arm group label: Enhanced Usual Care (EUC)
arm group type: Placebo Comparator
description: CBOs randomized to EUC will receive standardized monthly group education (45 min) regarding the symptoms of depression
intervention type: Behavioral
intervention name: MITHRA
description: A mobile based application (app) in CBOs to screen, track and treat mild to moderate depression among low income women using Healthy Activity Program (HAP),a WHO-recommended evidence-based intervention.
arm group label: Multiuser Interactive Health Response Application (MITHRA)
intervention type: Behavioral
intervention name: EUC
description: Group education on depression by community health workers
arm group label: Enhanced Usual Care (EUC)
criteria: 
gender: Female
gender based: Yes
gender description: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Amritha S Bhat, MD, MPH
role: Principal Investigator
affiliation: University of Washington
last name: Amritha S Bhat, MD, MPH
phone: 206-543-3117
email: amritha@uw.edu
last name: Natalie Franz, MPH
email: nfranz@uw.edu
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Amritha Subray Bhat
investigator title: Assistant Professor, Psychiatry
mesh term: Depression