Effects of brief family psychoeducation for caregivers of people with schizophrenia in Japan provided by visiting nurses: protocol for a cluster randomised controlled trial

INTRODUCTION: Development of a support system for families caring for people with schizophrenia in routine psychiatric care settings is an important issue worldwide. Regional mental health systems are inadequate for delivering effective services to such family members. Despite evidence that family psychoeducation (FPE) alleviates the burden of schizophrenia on families, its dissemination in routine clinical practice remains insufficient, suggesting the need for developing an effective and implementable intervention for family caregivers in the existing mental health system setting. In Japan, the visiting nurse service system would be a practical way of providing family services. Visiting nurses in local communities are involved in the everyday lives of people with schizophrenia and their families. Accordingly, visiting nurses understand their needs and are able to provide family support as a service covered by national health insurance. The purpose of this study is to discover whether a brief FPE programme provided by visiting nurses caring for people with schizophrenia will alleviate family burden through a cluster randomised controlled trial (cRCT). METHODS AND ANALYSIS: The study will be a two-arm, parallel-group (visiting nurse agency) cRCT. Forty-seven visiting nurse agencies will be randomly allocated to the brief FPE group (intervention group) or treatment as usual group (control group). Caregivers of people with schizophrenia will be recruited by visiting nurses using a randomly ordered list. The primary outcome will be caregiver burden, measured using the Japanese version of Zarit Burden Interview. Outcome assessments will be conducted at baseline, 1-month follow-up and 6-month follow-up. Multiple levels of three-way interactions in mixed models will be used to examine whether the brief FPE programme will alleviate the burden on caregivers relative to treatment as usual. ETHICS AND DISSEMINATION: The Research Ethics Committee of the Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Japan (No 2019065NI) approved this study. The results will be published in a scientific peer-reviewed journal. TRIAL REGISTRATION NUMBER: UMIN000038044.