Culturally adapted family intervention for people with schizophrenia in Indonesia (FUSION): a development and feasibility study protocol

Background: Mental illnesses comprise the single largest source of health-related economic burden globally, and low- and middle-income countries are disproportionately affected. The majority of people with schizophrenia who need treatment do not receive it and are often wholly reliant on family caregivers for daily care and support. Family interventions have an exceptionally robust evidence base for their efficacy in high-resource settings, but it is unknown whether they can produce equivalent effects in some low-resource settings where cultural beliefs, explanatory models of illness and contextual socio-economic issues differ. Methods: This protocol describes the methods for a randomised controlled trial to determine the feasibility of testing culturally adapt and refine an evidence-based, family intervention for relatives and caregivers of people with schizophrenia in Indonesia. The feasibility and acceptability of implementing our adapted, co-produced intervention via task shifting in primary care settings will be evaluated using the Medical Research Council framework for complex interventions. We will recruit 60 carer-service-user dyads and randomise them in a 1:1 ratio either to receive our manualised intervention or continue to receive treatment as usual. Healthcare workers in primary care settings will be trained to deliver family interventions using our manualised intervention by a family intervention specialist. Participants will complete the ECI, IEQ, KAST and GHQ. Service-user symptom level and relapse status will be measured using the PANSS at baseline, post-intervention and 3 months later by trained researchers. Fidelity to the intervention model will be measured using the FIPAS. Qualitative evaluation will further assist with refining the intervention, evaluating trial processes and evaluating acceptability. Discussion: National healthcare policy in Indonesia supports the delivery of mental health services in a complex network of primary care centres. This study will provide important information on the feasibility of delivering family interventions for people with schizophrenia via task shifting in primary care settings in Indonesia and allow further refinement of the intervention and trial processes.