An interventional study of Community Intervention and Healthy Activity Program (HAP) in Depression, sponsored by Sangath. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Sangath · Not applicable, Interventional, and Treatment
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.
(A) Contact Coverage Outcome
Inclusion Criteria
Exclusion Criteria
(B) Effectiveness Coverage Outcome
Inclusion Criteria
Exclusion Criteria
In addition to the facility model, village clusters in this arm will receive community intervention strategies delivered by community volunteers.
Behavioral: Community Intervention · Behavioral: Healthy Activity Program (HAP)
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.
Behavioral: Healthy Activity Program (HAP)
Community intervention strategies will be delivered by community volunteers (called Sangathis - which means companion in Konkani, one of the local languages) to i) enhance demand for the HAP treatment and ii) promote engagement with, and completion of, the HAP treatment. The community intervention is co-produced with local community members and includes strategies such as activities to increase awareness about depression (community meetings, street plays and health camps), and dissemination of psycho-educational materials (i.e., leaflets and posters), identify people with possible depression in the community, and facilitate access to HAP in the health centres. Additionally, the Sangathis will coordinate continuing care of people receiving HAP, through home visits to encourage behavioural activation, homework completion and following up with the counsellor, and engaging family members to support the patient in achieving treatment goals.
HAP includes the following strategies: psychoeducation, behavioural assessment, activity monitoring, activity structuring and scheduling, activation of social networks, and problem-solving. HAP will be delivered in an individual format. It entails three phases of treatment, delivered over six to eight sessions, each lasting up to 40 minutes, with the sessions being at weekly intervals. Sessions will be delivered face-to-face, at the health centre where the counsellors already work.
Contact coverage
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.
Time frame: During recruitment
Effectiveness coverage
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.
Time frame: Three months post recruitment
Sustained effectiveness
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.
Time frame: Six months post recruitment
Remission
Patient Health Questionnaire 9 items (PHQ-9 score) score \<10. . The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Time frame: Three months post recruitment
Remission
Patient Health Questionnaire 9 items (PHQ-9 score) score \<10. . The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Time frame: Six months post recruitment
Response to treatment
\>50% reduction in Patient Health Questionnaire 9 items (PHQ-9 score) score. The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Time frame: Three months post recruitment
Response to treatment
\>50% reduction in Patient Health Questionnaire 9 items (PHQ-9 score) score. The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Time frame: Six months post recruitment
Client Service Receipt Inventory
Out-of-pocket costs for receiving care and the related non-medical costs
Time frame: 3- and 6- months post recruitment
WHO Disability Assessment Schedule (WHODAS 2.0)
Standardized disability scores used to estimate Quality Adjusted Life Years (QALYs). The 12-item WHODAS 2.0 score ranges from 12 to 60, where higher scores indicate higher disability or loss of function.
Time frame: Baseline, 3- and 6- months post recruitment
Survey form for collecting costs of receiving HAP intervention to patients
Out-of-pocket costs for receiving HAP intervention (e.g. time loss, travel)
Time frame: 3 months post recruitment
Inventory form for collecting system-level economic costs of delivering interventions
System-level costs: Economic costs in WHO six building blocks for delivering the interventions
Time frame: Monthly, through study completion up to approximately 12 months
Depression awareness
Awareness about depression. This will be a bespoke tool developed for our trial and will have questions to assess awareness related to depression based on the information disseminated in our community intervention and higher scores will indicate greater awareness.
Time frame: Baseline, 6, 12 and 18 months of implementation
Perceived social support
Perception of social support received. This will be a bespoke tool developed for our trial and will have questions to assess perceived support related to support provided by community volunteers in our community intervention and higher scores will indicate greater support.
Time frame: 3- and 6- months post recruitment
Multidimensional Scale of Perceived Social Support (MSPSS)
12 item short instrument designed to measure an individual's perception of support from 3 sources: family, friends and a significant other. Minimum score 12 and maximum 84
Time frame: Baseline, 3- and 6-months post-recruitment
Treatment completion
Met treatment goals or completed the maximum number of sessions or were referred to mental health specialists
Time frame: Across 12 months of implementation
Behavioral activation
Level of behavioral activation measured using PREMIUM Abbreviated Activation Scale. This is a five-item scale, originally developed based on the Behavioural Activation for Depression Scale. It includes five self-reported indicators and the total score can range from 0 to 20. Higher scores indicate greater level of behavioural activation such as engagement with a variety of activities, and associated pleasure and mastery.
Time frame: Baseline, 3- and 6- months post recruitment.
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