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序贯多项分配随机试验,评估针对出院精神科患者的自杀风险管理的简短接触干预:实施研究方案。

Sequential multiple assignment randomised trial of a brief contact intervention for suicide risk management among discharged psychiatric patients: an implementation study protocol.

机构信息

Department of Public Health, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.

Sun Yat-sen Global Health Institute, Sun Yat-Sen University School of Public Health, Guangzhou, Guangdong, China.

出版信息

BMJ Open. 2021 Nov 26;11(11):e054131. doi: 10.1136/bmjopen-2021-054131.

DOI:10.1136/bmjopen-2021-054131
PMID:34836907
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8628333/
Abstract

INTRODUCTION

The postdischarge suicide risk among psychiatric patients is significantly higher than it is among patients with other diseases and general population. The brief contact interventions (BCIs) are recommended to decrease suicide risk in areas with limited mental health service resources like China. This study aims to develop a postdischarge suicide intervention strategy based on BCIs and evaluate its implementability under the implementation outcome framework.

METHODS AND ANALYSIS

This study will invite psychiatric patients and family members, clinical and community mental health service providers as the community team to develop a postdischarge suicide intervention strategy. The study will recruit 312 patients with psychotic symptoms and 312 patients with major depressive disorder discharged from Shenzhen Kangning Hospital (SKH) in a Sequential Multiple Assignment Randomised Trial. Participants will be initially randomised into two intervention groups to receive BCIs monthly and weekly, and they will be rerandomised into three intervention groups to receive BCIs monthly, biweekly and weekly at 3 months after discharge according to the change of their suicide risk. Follow-ups are scheduled at 1, 3, 6 and 12 months after discharge. With the intention-to-treat approach, generalised estimating equation and survival analysis will be applied. This study will also collect qualitative and quantitative information on implementation and service outcomes from the community team.

ETHICS/DISSEMINATION: This study has received ethical approval from the Ethics Committee Review Board of SKH. All participants will provide written informed consent prior to enrolment. The findings of the study will be disseminated through peer-reviewed scientific journals, conference presentations. A project report will be submitted to the National Natural Science Foundation of China as the concluding report of this funded project, and to the mental health authorities in the Shenzhen to refine and apply evidence-based and pragmatic interventions into health systems for postdischarge suicide prevention.

TRIAL REGISTRATION NUMBER

NCT04907669.

摘要

简介

精神科患者出院后的自杀风险明显高于其他疾病患者和一般人群。在精神卫生服务资源有限的地区,如中国,建议采用简短接触干预(BCIs)来降低自杀风险。本研究旨在基于 BCI 制定出院后自杀干预策略,并根据实施结果框架评估其实施可行性。

方法和分析

本研究将邀请精神科患者及其家属、临床和社区精神卫生服务提供者作为社区团队,制定出院后自杀干预策略。该研究将在深圳康宁医院(SKH)招募 312 名有精神病症状的患者和 312 名有重性抑郁障碍的患者,进行序贯多项分配随机试验。参与者将首先随机分为两组,每月和每周接受 BCI,根据自杀风险的变化,在出院后 3 个月时再次随机分为三组,每月、双周和每周接受 BCI。随访计划在出院后 1、3、6 和 12 个月进行。采用意向治疗分析、广义估计方程和生存分析。本研究还将从社区团队收集实施和服务结果的定性和定量信息。

伦理/传播:本研究已获得 SKH 伦理委员会审查委员会的伦理批准。所有参与者在入组前都将提供书面知情同意书。研究结果将通过同行评议的科学期刊、会议演讲等方式进行传播。项目报告将提交给国家自然科学基金作为该资助项目的总结报告,并提交给深圳市精神卫生当局,以完善和应用基于证据和实用的干预措施,纳入卫生系统,预防出院后自杀。

试验注册号

NCT04907669。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/22f2/8628333/9c8ee17b01b1/bmjopen-2021-054131f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/22f2/8628333/f873ba6107b1/bmjopen-2021-054131f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/22f2/8628333/17e0effdbf9d/bmjopen-2021-054131f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/22f2/8628333/ee789bb5acef/bmjopen-2021-054131f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/22f2/8628333/9c8ee17b01b1/bmjopen-2021-054131f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/22f2/8628333/f873ba6107b1/bmjopen-2021-054131f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/22f2/8628333/17e0effdbf9d/bmjopen-2021-054131f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/22f2/8628333/ee789bb5acef/bmjopen-2021-054131f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/22f2/8628333/9c8ee17b01b1/bmjopen-2021-054131f04.jpg

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