Sequential multiple assignment randomised trial of a brief contact intervention for suicide risk management among discharged psychiatric patients: an implementation study protocol.
Sequential multiple assignment randomised trial of a brief contact intervention for suicide risk management among discharged psychiatric patients: an implementation study protocol.
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DOI：
10.1136/bmjopen-2021-054131
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发表时间：
2021-11-26
期刊：
影响因子：
2.9
通讯作者：
Hou F
中科院分区：
文献类型：
--
作者：
Liu H;Chen G;Li J;Hao C;Zhang B;Bai Y;Song L;Chen C;Xie H;Liu T;Caine ED;Hou F
精神病患者出院后自杀风险显著高于其他疾病患者和一般人群。在中国这样精神卫生服务资源有限的地区，建议采用短暂接触干预（BCI）来降低自杀风险。本研究旨在发展一个基于行为能力指数的出院后自杀干预策略，并在实施结果框架下评估其可实施性。本研究将邀请精神病患者及其家属、临床及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。该研究将在一项序贯多分配随机试验中招募312名从深圳康宁医院（SKH）出院的精神病性症状患者和312名重性抑郁障碍患者。受试者最初将被随机分为两个干预组，每月和每周接受一次BCI，并将根据其自杀风险的变化在出院后3个月重新随机分为三个干预组，每月，每两周和每周接受一次BCI。计划在出院后1、3、6和12个月进行随访。采用意向治疗方法，将应用广义估计方程和生存分析。这项研究亦会从社区工作队收集有关推行计划和服务成效的质和量资料。本研究已获得SKH伦理委员会审查委员会的伦理批准。所有受试者将在入组前提供书面知情同意书。研究结果将通过同行评审的科学期刊和会议报告传播。项目报告将作为本资助项目的总结报告提交国家自然科学基金委员会，并提交深圳市精神卫生部门，以完善和应用循证和务实的干预措施，预防出院后自杀。NCT 04907669。
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. 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. 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. NCT04907669.
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