IMPlementation of Evidence Based Facility and Community Interventions to Reduce the Treatment Gap for depRESSion
- Conditions
- Depression
- Interventions
- Behavioral: Community InterventionBehavioral: Healthy Activity Program (HAP)
- Registration Number
- NCT05890222
- Lead Sponsor
- Sangath
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 784
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Community Model Healthy Activity Program (HAP) In addition to the facility model, village clusters in this arm will receive community intervention strategies delivered by community volunteers. Community Model Community Intervention In addition to the facility model, village clusters in this arm will receive community intervention strategies delivered by community volunteers. Facility Model 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.
- Primary Outcome Measures
Name Time Method Effectiveness coverage 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 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 Outcome Measures
Name Time Method Sustained effectiveness Six 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.
Client Service Receipt Inventory 3- and 6- months post recruitment Out-of-pocket costs for receiving care and the related non-medical costs
Remission Six months post recruitment 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.
Response to treatment Six months post recruitment \>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.
WHO Disability Assessment Schedule (WHODAS 2.0) Baseline, 3- and 6- months post recruitment 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.
Survey form for collecting costs of receiving HAP intervention to patients 3 months post recruitment Out-of-pocket costs for receiving HAP intervention (e.g. time loss, travel)
Inventory form for collecting system-level economic costs of delivering interventions Monthly, through study completion up to approximately 12 months System-level costs: Economic costs in WHO six building blocks for delivering the interventions
Depression awareness Baseline, 6, 12 and 18 months of implementation 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.
Perceived social support 3- and 6- months post recruitment 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.
Multidimensional Scale of Perceived Social Support (MSPSS) Baseline, 3- and 6-months post-recruitment 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
Treatment completion Across 12 months of implementation Met treatment goals or completed the maximum number of sessions or were referred to mental health specialists
Behavioral activation Baseline, 3- and 6- months post recruitment. 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.
Trial Locations
- Locations (1)
Sangath
🇮🇳Goa, India