You are here

  • Home
  • Archive
  • Volume 10, Issue 4
  • Effects of brief family psychoeducation for caregivers of people with schizophrenia in Japan provided by visiting nurses: protocol for a cluster randomised controlled trial

Article Text

Article menu

Download PDFPDF

XML
Mental health
Protocol
Effects of brief family psychoeducation for caregivers of people with schizophrenia in Japan provided by visiting nurses: protocol for a cluster randomised controlled trial
  1. Naonori Yasuma1,2,
  2. Sayaka Sato2,
  3. Sosei Yamaguchi2,
  4. Asami Matsunaga2,
  5. Takuma Shiozawa2,
  6. Hisateru Tachimori3,
  7. Kazuhiro Watanabe1,
  8. Kotaro Imamura1,
  9. Daisuke Nishi1,
  10. Chiyo Fujii2,
  11. Norito Kawakami1
  1. 1Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan
  2. 2Department of Community Mental Health and Law, National Institute of Mental Health, National Center of Neurology and Psychiatry, Kodaira, Tokyo, Japan
  3. 3Department of Clinical Epidemiology, Translational Medical Center, National Institute of Mental Health, National Center of Neurology and Psychiatry, Kodaira, Tokyo, Japan
  1. Correspondence to Dr Naonori Yasuma; nnyy712{at}gmail.com

Abstract

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.

  • brief family psychoeducation
  • schizophrenia
  • caregivers
  • visiting nurses
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2019-034425

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • Contributors NY is the principal investigator responsible for the initial draft of this manuscript and organising and implementing the study. NY and KW calculated the sample size. NY, KW, SY and AM decided on the analytical strategy. SS, TS, HT, KI, DN, CF and NK helped throughout the development of the interventions and gave valuable feedback on the study protocol. All authors have read and approved the final manuscript.

    • Funding This work is supported by the fundamental study on effective community services for people with severe mental disorders and their families.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Patient consent for publication Obtained.

    • Ethics approval Research Committee of the Graduate School of Medicine and the Faculty of Medicine at The University of Tokyo, Japan.

    • Provenance and peer review Not commissioned; externally peer reviewed.