Using participatory action research and theory of change to integrate depression care services at rural primary health centres in India: a cluster-randomized controlled implementation-effectiveness study

Research question: How does a rural primary depression care model informed by community perspectives gathered through Participatory Action Research (PAR) and a Theory of Change (ToC) approach, impact depression case-detection and treatment initiation in Madhya Pradesh, India? Background: Nearly 50 million people live with depression in India. Scarce evidence-based implementation models in India have focused on adequate integration of depression care into Primary Health Centres (PHCs) where most healthcare is delivered. Efforts so far have largely been clinic-focused, with limited community engagement to identify local needs and perceptions. PAR is well-established to involve mental health service-users in high-income countries, however, few similar studies in LMICs are available Aims and objectives: We aim develop and test the effectiveness of the PAR-and ToC informed rural depression care model. We will define the components of the program theory developed as part of the ToC methodology to guide the depression care implementation model, and evaluate if the model will significantly improve depression case detection and treatment initiation. Methods: Phase-1 will involve PAR-informed formative work (e.g., focus groups, in-depth interviews, stigma surveys, or mapping daily work schedules of clinic staff) to include relevant voices, particularly, the repeated efforts to test and readjust our assumptions against the lived realities of local stakeholders i.e., clinic staff and linked rural communities. These ‘PAR cycles’ will initially define the ‘problem’ with the community (e.g., how to best seek care at the PHC through the frontline worker), design a suitable ‘action,’ ‘discuss’ the action with the community, observe and gather data on the results after ‘piloting’ the action, and then analyse the action and its impact, to inform the next iteration of the ‘research–action cycle.’ We will include four iterative rounds of community consultation to refine the model. In phase-2, the final implementation model will be evaluated through a cluster-randomized controlled trial with nine clinics deploying the model (with routine district team support) and nine ‘control’ clinics delivering depression care through routine district team support alone. We will evaluate model effectiveness through a comparison of depression case-detection rates between arms (primary outcome) in addition to secondary outcomes of cases referred to the clinic doctor, initiated on treatment and followed up for continued care. We will also cost the development and delivery of the model using WHO’s health system building blocks. Timelines for delivery: Year-1 will include formative work to develop the draft model through a theory of change workshop; year-2 will help revise the model through community consultation and trialling the model in 18 clinics, and year-3 will complete the main trial implementation, follow-up community consultations, and outcome analysis. Anticipated impact and dissemination: This project (2024 to 2027) aims to integrate depression care in rural primary care clinics to develop a viable rural depression care model that is informed by the community, which is scalable to other districts of Madhya Pradesh and potentially at the state-level. We will conduct dissemination meetings with state and central health system officials annually to discuss the achieved milestones and plans for adoption of the depression care model across primary care clinics.