IMPlementation of Evidence Based Facility and Community Interventions to Reduce the Treatment Gap for depRESSion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 816
- Locations
- 2
- Primary Endpoint
- Effectiveness coverage
Study Overview
Brief Summary
The goal of this Hybrid Type 2 Implementation-Effectiveness Cluster Randomised Controlled Trial is to reduce the treatment gap for depression through the integrated implementation of interventions in facility and community platforms, in Goa, India. The primary question is to examine whether a community intervention ("Community Model") enhances the demand for, and improves the outcomes of, an evidence-based, brief psychological treatment for depression delivered by non-specialist health workers in primary health care facilities ("Facility Model"). Participants in the Facility Model arm will receive only a psychosocial intervention for depression (the Healthy Activity Program - HAP) while participants in the Community Model will receive both the HAP and the community intervention. We will compare the Facility Model and the Community Model to assess if the latter is superior in increasing the demand for depression treatment in primary care, increasing uptake of treatment by people with depression, increasing treatment completion rates, and reducing the severity of depression.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(A) Contact Coverage Outcome
- •Inclusion Criteria
- •Adults (>18 years)
- •Residing in the clusters included in the trial
- •Speak English or one of the local languages (Konkani, Marathi, Hindi)
Exclusion Criteria
- •Patients with significant speech, hearing, or language impairment that interferes with completion of the screening and/or receipt of psychosocial intervention
- •Patients who present to the health centre for emergency medical attention
- •Patients with active psychotic symptoms
- •(B) Effectiveness Coverage Outcome
- •Inclusion Criteria
- •Adults (>18 years);
- •Residing in the clusters included in the trial
- •Speak English or one of the local languages (Konkani, Marathi, Hindi).
- •Screen positive for moderately severe or severe depression (total score >14) on the Patient Health Questionnaire-9 items (PHQ-9)
- •Exclusion Criteria
- •Patients with significant speech, hearing, or language impairment that interferes with completion of the screening and/or receipt of psychosocial intervention
- •Patients who present to the health centre for emergency medical attention
- •Patients with active psychotic symptoms
Arms & Interventions
Community Model
In addition to the facility model, village clusters in this arm will receive community intervention strategies delivered by community volunteers.
Intervention: Community Intervention (Behavioral)
Community Model
In addition to the facility model, village clusters in this arm will receive community intervention strategies delivered by community volunteers.
Intervention: Healthy Activity Program (HAP) (Behavioral)
Facility Model
The HAP, a manualized and evidence-based psychological treatment based on behavioural activation, will be delivered by existing healthcare workers (called counsellors from here onwards) within the health centres who will be trained to deliver the HAP.
Intervention: Healthy Activity Program (HAP) (Behavioral)
Outcomes
Primary Outcomes
Effectiveness coverage
Time Frame: Three months post recruitment
Mean Patient Health Questionnaire 9 items (PHQ-9 score). The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Contact coverage
Time Frame: During recruitment
Patient Health Questionnaire 9 items (PHQ-9) score \>4. The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Secondary Outcomes
- Sustained effectiveness(Six months post recruitment)
- Client Service Receipt Inventory(3- and 6- months post recruitment)
- Remission(Six months post recruitment)
- Response to treatment(Six months post recruitment)
- WHO Disability Assessment Schedule (WHODAS 2.0)(Baseline, 3- and 6- months post recruitment)
- Survey form for collecting costs of receiving HAP intervention to patients(3 months post recruitment)
- Inventory form for collecting system-level economic costs of delivering interventions(Monthly, through study completion up to approximately 12 months)
- Depression awareness(Baseline, 6, 12 and 18 months of implementation)
- Perceived social support(3- and 6- months post recruitment)
- Multidimensional Scale of Perceived Social Support (MSPSS)(Baseline, 3- and 6-months post-recruitment)
- Treatment completion(Across 12 months of implementation)
- Behavioral activation(Baseline, 3- and 6- months post recruitment.)