Trial Outcomes & Findings for Mobile Mental Health in Community-Based Organizations (NCT NCT04480021)
NCT ID: NCT04480021
Last Updated: 2024-08-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
85 participants
Primary outcome timeframe
3 months
Results posted on
2024-08-13
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
36
|
|
Overall Study
COMPLETED
|
46
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
Baseline Characteristics
Mobile Mental Health in Community-Based Organizations
Baseline characteristics by cohort
| Measure |
Multiuser Interactive Health Response Application (MITHRA)
n=49 Participants
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.
|
Enhanced Usual Care (EUC)
n=36 Participants
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
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.6 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
40.7 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
41.2 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
49 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
49 participants
n=5 Participants
|
36 participants
n=7 Participants
|
85 participants
n=5 Participants
|
|
QIDS-SR
|
4.0 units on a scale
n=5 Participants
|
2.5 units on a scale
n=7 Participants
|
3.0 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Usage rates only calculated for those assigned to intervention.
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.
Outcome measures
| Measure |
Multiuser Interactive Health Response Application (MITHRA)
n=49 Participants
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.
|
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
|
|---|---|---|
|
Usage Rates
|
47 participants
|
—
|
SECONDARY outcome
Timeframe: Change from baseline depression score (QIDS SR) at 3 monthsPopulation: Participants with assessments available at 3 months
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
Outcome measures
| Measure |
Multiuser Interactive Health Response Application (MITHRA)
n=47 Participants
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.
|
Enhanced Usual Care (EUC)
n=31 Participants
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
|
|---|---|---|
|
Depression
|
0 score on a scale
Interval -2.0 to 1.0
|
0 score on a scale
Interval -2.0 to 1.0
|
SECONDARY outcome
Timeframe: Change from baseline depression score (QIDS SR) at 6 monthsPopulation: Participants with assessments available at 6 months
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
Outcome measures
| Measure |
Multiuser Interactive Health Response Application (MITHRA)
n=46 Participants
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.
|
Enhanced Usual Care (EUC)
n=32 Participants
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
|
|---|---|---|
|
Depression
|
-1.0 score on a scale
Interval -3.0 to 1.0
|
0 score on a scale
Interval -0.75 to 2.75
|
Adverse Events
Multiuser Interactive Health Response Application (MITHRA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Usual Care (EUC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place