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| ID | Type | Description | Link |
|---|---|---|---|
| R21MH124073-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute of Mental Health (NIMH) | NIH |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiuser Interactive Health Response Application (MITHRA) | Experimental | 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. |
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| Enhanced Usual Care (EUC) | Placebo Comparator | CBOs randomized to EUC will receive standardized monthly group education (45 min) regarding the symptoms of depression |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MITHRA | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Amritha S Bhat, MD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. John's Research Institute | Bengaluru | India |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | Enhanced Usual Care (EUC) | CBOs randomized to EUC will receive standardized monthly group education (45 min) regarding the symptoms of depression EUC: Group education on depression by community health workers |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Usage rates only calculated for those assigned to intervention. | Posted | Number | participants | 3 months |
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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Women with severe depression may not attend Self Help Group meetings. The intervention would ideally include a way to involve women with severe depressive symptoms, and ensure that they get the appropriate level of care.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amritha Bhat | University of Washington | 206-543-3117 | amritha@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 16, 2024 | Jul 17, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| EUC | Behavioral | Group education on depression by community health workers |
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| 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 |
| BG001 | Enhanced Usual Care (EUC) | CBOs randomized to EUC will receive standardized monthly group education (45 min) regarding the symptoms of depression EUC: Group education on depression by community health workers |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| QIDS-SR | Quick Inventory of Depressive Symptomatology Range of scores 0 to 27 with higher scores indicating more depressive symptoms | Median | Inter-Quartile Range | units on a scale |
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| Secondary | 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 | Participants with assessments available at 3 months | Posted | Median | Inter-Quartile Range | score on a scale | Change from baseline depression score (QIDS SR) at 3 months |
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| Secondary | 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 | Participants with assessments available at 6 months | Posted | Median | Inter-Quartile Range | score on a scale | Change from baseline depression score (QIDS SR) at 6 months |
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| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Enhanced Usual Care (EUC) | CBOs randomized to EUC will receive standardized monthly group education (45 min) regarding the symptoms of depression EUC: Group education on depression by community health workers | 0 | 36 | 0 | 36 | 0 | 36 |
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