Mobile Mental Health in Community-Based Organizations

Study Overview
=================
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.

Official Title
-----------------
Mobile Mental Health in Community-Based Organizations: A Stepped Care Approach to Women's Mental Health

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Behavioral: MITHRA
* Behavioral: EUC


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multiuser Interactive Health Response Application (MITHRA)<br>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. | Behavioral: MITHRA<br>* 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.<br>|
| Placebo Comparator: Enhanced Usual Care (EUC)<br>CBOs randomized to EUC will receive standardized monthly group education (45 min) regarding the symptoms of depression | Behavioral: EUC<br>* Group education on depression by community health workers<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 
| 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Change from baseline depression score (QIDS SR) at 3 months | 
| 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) | Change from baseline depression score (QIDS SR) at 6 months |