Mobile Mental Health in Community-Based Organizations (MITHRA)

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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: MITHRA; Behavioral: EUC

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 community-based 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 community-based 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 video-conferenced 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.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Bengaluru, India
    • St. John's Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usage Rates	The investigators 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. Only the MITHRA arm will be considered, and completion of 50% of modules will be considered adequate usage.	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) Scores range from 0 to 27 with higher scores indicating more symptoms	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) Range of scores is 0 to 27, with higher scores indicated more symptoms	Change from baseline depression score (QIDS SR) at 6 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Amritha S Bhat, MD, MPH, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): August 7, 2023

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: STUDY00010415; R21MH124073-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No