Helping people with psychosis with a low-cost intervention DIALOG+: protocol for the economic evaluation in a randomised control trial in India and Pakistan

Background: Approximately 69%–89% of people with severe mental illnesses, particularly psychosis, experience a treatment gap in low- and middle-income countries (LMICs) due to factors such as low public spending on health and weak healthcare systems. The PIECEs project aims to assess the effectiveness and cost-effectiveness of a solution-focused resource-oriented approach (DIALOG+) for improving the quality of life and mental well-being of people with psychosis in India and Pakistan. Methods: The research design of this analysis is an economic evaluation piggybacked on the PIECEs randomised control trial to test the feasibility of DIALOG+ in India and Pakistan. It implies a cost-utility analysis with a health system perspective. The costs include the cost of the intervention, the cost of healthcare providers and the cost to the household. The primary outcome will be quality-adjusted life years. Incremental cost, incremental effectiveness and incremental cost-effectiveness ratios will be calculated using linear regression models with a hierarchical data structure. A probabilistic sensitivity analysis will be carried out to test for the uncertainty surrounding the estimates of cost-effectiveness. Discussion: This study will provide evidence of a patient-centred approach to improve the quality of community-based care for people with psychosis in India and Pakistan. The economic evaluation will support efforts to scale up low-cost healthcare interventions such as DIALOG+ to rural and unserved areas, which is otherwise challenging in the resource-constrained health systems in many LMICs. Conclusion: The evidence on the cost-effectiveness of DIALOG+ will contribute to efforts to improve community-based care and the quality of life for millions of people suffering from mental health problems in India and Pakistan who experience psychosis. Ethics and dissemination: This study is approved by the Queen Mary Ethics of Research Committee (UK), Institutional Ethics Committee of SCARF (India), IRD’s Independent Institutional Review Board (IRD_IRB_2021_01_005) (Pakistan), Karawan-e-Hayat Management Committee (Institutional Approval) (Pakistan), Jinnah Postgraduate Medical Centre Research Committee (NO.F.2-81/2021-GENL/60224/JPMC) (Pakistan), Aga Khan’s Ethics Research Committee (2021-5933-17533) (Pakistan) and National Bio-Ethics Committee, Pakistan (Ref: No.4–87/NBC-774/22/2037 Date: 17 May 2022). The findings of this research will be widely disseminated through research publications and engagement with the communities and the healthcare providers in the public and not-for-profit sectors. Trial registration number ISRCTN13022816.