Community-based rehabilitation interventions on quality of care for people with schizophrenia in China (CRISC): study protocol for a cluster-randomized controlled trial

BACKGROUND: International consensus shows that community-based rehabilitation (CBR) service is an effective way to improve functioning and negative symptoms and address the treatment gap for schizophrenia. Rigorous trials are needed in China to demonstrate effective and scalable CBR interventions to significantly improve outcomes for people with schizophrenia and to provide evidence of the economic benefits. The objectives of this trial are to examine the effectiveness of CBR as an adjunct to test the usual facility-cased care (FBC) in comparison to FBC alone in improving a range of outcomes in people with schizophrenia and their caregivers. METHODS: This trial is a cluster randomized controlled trial design in China. The trial will be conducted at three districts of Weifang city, Shandong province. Eligible participants will be identified from the psychiatric management system where community-dwelling patients with schizophrenia have been registered. Participants will be recruited after providing informed consent. 18 sub-districts will be randomly allocated in a 1:1 ratio to facility-based care (FBC) plus CBR (intervention arm) or FBC alone (control arm). The structured CBR intervention will be delivered by trained psychiatric nurses or community health workers. We aim to recruit 264 participants. The primary outcomes include symptoms of schizophrenia, personal and social function, quality of life, family burden of caring, etc. The study will be conducted according to good ethical practice, data analysis and reporting guidelines. DISCUSSION: If the hypothesized clinical benefit and cost-effectiveness of CBR intervention are confirmed, this trial will provide significant implications for policy makers and practitioners to scale up rehabilitation services, as well as for people with schizophrenia and their family to promote recovery and social inclusion, and to alleviate the burden of care. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2200066945). Registered December 22, 2022.