Effectiveness and cost-effectiveness of a community intervention in enhancing access to care and improving clinical outcomes for depression: a protocol for a cluster randomised controlled trial in India.

Background: Although depression is the leading cause of disability worldwide, treatment coverage for the condition is inadequate. Supply-side barriers (e.g. shortage of specialist mental health professionals) and demand-side barriers (e.g. lack of awareness about depression) lead to limited availability of evidence-based interventions, poor demand for care, and low levels of adherence to care. The aim of our study is to examine if the addition of a community intervention delivered by community volunteers enhances the population-level impact of an evidence based psychosocial intervention (Healthy Activity Program [HAP]) in routine primary care by increasing demand for HAP and improving HAP adherence and effectiveness.

Methods: A hybrid type 2 effectiveness implementation cluster randomised controlled trial will be implemented in the state of Goa, India. Twenty-eight clusters of villages and their associated public sector health centres will be randomly allocated through restricted randomisation. Clusters will be randomly allocated to the 'Community Model' or 'Facility Model' arms. All clusters will offer the HAP and clusters in the 'Community Model' arm will additionally receive activities delivered by community volunteers ("Sangathis") to increase awareness about depression and support demand for and adherence to HAP. The primary outcomes are Contact Coverage (Patient Health Questionnaire [PHQ-9] score > 4 as a proportion of those screened) and Effectiveness Coverage (mean PHQ-9 score amongst those who score ≥ 15 at baseline, i.e. those who have moderately severe to severe depression) at 3 months post-recruitment. Additional outcomes at 3 and 6 months will assess sustained effectiveness, remission, response to treatment, depression awareness, social support, treatment completion, and activation levels. Economic and disability outcomes will be assessed to estimate incremental cost-effectiveness ratios. Implementation will be evaluated through process data and qualitative data informed by the RE-AIM framework. A minimum of 79488 primary care attenders will be screened for the Contact Coverage outcome, and 588 individuals with PHQ-9 ≥ 15 will be recruited for the Effectiveness Coverage outcome.

Discussion: If effective, our community intervention will have relevance to India's Ayushman Bharat universal healthcare programme which is scaling up care for depression in primary care, and also to other low- and middle- income countries.

Trial registration: Registered on ClincalTrials.gov ( NCT05890222 .) on 12/05/2023.