Health Condition 1: F331- Major depressive disorder, recurrent, moderate
Conditions
Interventions
Intervention1: Contextually informed rural depression care model.: The Contextually Informed Depression Care Model will be our intervention, delivered to the intervention arm facilities for the durati
b) additional contextually-suited training for HWC staff and ASHAs for engaging rural community members towards depression care-seeking, community-based screening (using PHQ-2), and facilitating clini
c) community engagement component towards stigma-reduction and accessing and actively participating in depression care
d) external implementation support for HWC staff (by project team)
e) data reporting and documenting systems for HWC staff
f) periodic evaluation metrics and processes (for project team).
Control Intervention1: Routine Primary Depression Care Model: Routine Primary Depression Care Model
Sponsors
NIHR
Eligibility
Inclusion criteria
Inclusion criteria: The trial will be conducted in two phases. Inclusion criteria for each phase are as below Phase 1 We will engage rural community members, community health workers (like ASHA workers who bridge the community members with the primary care clinics), primary care clinic staff and health system officials for PAR (qualitative data collection) activities. Phase 2 1) PHC-HWCs (units of randomisation)The study will have the following clinic inclusion criteria a) Functioning PHC-HWC under Ayushman Bharat program b) Rural location of the PHC-HWC c) Presence of functioning community health workers or ASHAs, which serve as the link between the PHC-HWC and the rural community. 2) Patients With respect to patient inclusion criteria, adult clinic outpatients (age 18 years or plus) or persons identified in the community of any sex (including pregnant women) who screen positive for depression (PHQ-9 score 10 or above) and get initiated on treatment at the participating PHC-HWCs will be invited to enroll in this trial.
Exclusion criteria
Exclusion criteria: Phase 1: Potential participants not willing to provide signed informed consent. Phase 2: 1) PHC-HWCs: The study will have the following clinic exclusion criteria: 1) PHCs NOT functioning HWC under Ayushman Bharat program; b) urban PHC-HWC; c) absence of actively functioning community health workers or ASHAs. 2. Patients: Outpatients will be excluded if they have significant speech, hearing, language, or cognitive impairment impacting their ability to provide informed consent and complete study assessments, those needing urgent medical or psychiatric attention, those not planning to stay in the study catchment area for at least three months, or those who do not understand Hindi (the local language).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Primary Implementation outcome: The primary implementation outcome will be the depression case detection rates, the case being defined as a score of 10 or above on the nine-item Patient Health Questionnaire (PHQ-9). 2. Primary Patient outcome: The primary patient outcome will include a comparison of remission rates on PHQ-9 (score of less than 5) between arms (control and intervention). Timepoint: Primary Implementation outcome: monthly (every 4 week) up to 9 months. Primary Patient outcome: Baseline and at 3-month (12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Implementation outcomes Patient outcomes Intervention development cost Intervention delivery cost Implementation process measures Timepoint: Implementation outcomes- Periodically Patient outcomes: At baseline, & at 3-month follow up. Intervention development cost- Will be collected towards the end of the trial. Intervention delivery cost- Will be collected towards the end of the trial. Implementation process measures- This measure will be collected throughout the implementation of the trial. | — |
Countries
India
Contacts
Public ContactDr Ameya P Bondre
Sangath
Outcome results
None listed