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
About this trial
This is an interventional health services research trial for Depression
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
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
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
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Mobile Mental Health in Community-Based Organizations
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