search
Back to results

Mobile Mental Health in Community-Based Organizations (MITHRA)

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MITHRA
EUC
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • Resident of the village (i.e. not a guest attendee)
  • Plans to attend CBO meetings regularly.

Exclusion Criteria:

  • Diagnosed with severe mental illness such as bipolar disorder or schizophrenia (measured by self report / socio demographic questionnaire)
  • Suicide attempt or severe alcohol or substance use in the past 6 months (measured by self report / socio demographic questionnaire)
  • Unable to participate in informed consent discussion

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Multiuser Interactive Health Response Application (MITHRA)

    Enhanced Usual Care (EUC)

    Arm 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.

    CBOs randomized to EUC will receive standardized monthly group education (45 min) regarding the symptoms of depression

    Outcomes

    Primary Outcome Measures

    Usage rates
    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.
    Usage rates
    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.

    Secondary Outcome Measures

    Depression
    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)
    Depression
    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)

    Full Information

    First Posted
    July 10, 2020
    Last Updated
    July 16, 2020
    Sponsor
    University of Washington
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04480021
    Brief Title
    Mobile Mental Health in Community-Based Organizations
    Acronym
    MITHRA
    Official Title
    Mobile Mental Health in Community-Based Organizations: A Stepped Care Approach to Women's Mental Health
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2021 (Anticipated)
    Primary Completion Date
    April 2022 (Anticipated)
    Study Completion Date
    August 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Washington

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Multiuser Interactive Health Response Application (MITHRA)
    Arm Type
    Experimental
    Arm 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 Title
    Enhanced Usual Care (EUC)
    Arm Type
    Placebo Comparator
    Arm Description
    CBOs randomized to EUC will receive standardized monthly group education (45 min) regarding the symptoms of depression
    Intervention Type
    Behavioral
    Intervention Name(s)
    MITHRA
    Intervention 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    EUC
    Intervention Description
    Group education on depression by community health workers
    Primary Outcome Measure Information:
    Title
    Usage rates
    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.
    Time Frame
    Baseline
    Title
    Usage rates
    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.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Depression
    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)
    Time Frame
    Change from baseline depression score (QIDS SR) at 3 months
    Title
    Depression
    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)
    Time Frame
    Change from baseline depression score (QIDS SR) at 6 months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 years Resident of the village (i.e. not a guest attendee) Plans to attend CBO meetings regularly. Exclusion Criteria: Diagnosed with severe mental illness such as bipolar disorder or schizophrenia (measured by self report / socio demographic questionnaire) Suicide attempt or severe alcohol or substance use in the past 6 months (measured by self report / socio demographic questionnaire) Unable to participate in informed consent discussion
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amritha S Bhat, MD, MPH
    Phone
    206-543-3117
    Email
    amritha@uw.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Natalie Franz, MPH
    Email
    nfranz@uw.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amritha S Bhat, MD, MPH
    Organizational Affiliation
    University of Washington
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Mobile Mental Health in Community-Based Organizations

    We'll reach out to this number within 24 hrs