CRIMSON [危机计划影响:主观和客观强制和参与]方案:一项减少精神病人强制治疗的联合危机计划随机对照试验。
CRIMSON [CRisis plan IMpact: Subjective and Objective coercion and eNgagement] protocol: a randomised controlled trial of joint crisis plans to reduce compulsory treatment of people with psychosis.
机构信息
Health Service and Population Research Department, Institute of Psychiatry, King's College London, UK.
出版信息
Trials. 2010 Nov 5;11:102. doi: 10.1186/1745-6215-11-102.
BACKGROUND
The use of compulsory treatment under the Mental Health Act (MHA) has continued to rise in the UK and in other countries. The Joint Crisis Plan (JCP) is a statement of service users' wishes for treatment in the event of a future mental health crisis. It is developed with the clinical team and an independent facilitator. A recent pilot RCT showed a reduction in the use of the MHA amongst service users with a JCP. The JCP is the only intervention that has been shown to reduce compulsory treatment in this way. The CRIMSON trial aims to determine if JCPs, compared with treatment as usual, are effective in reducing the use of the MHA in a range of treatment settings across the UK.
METHODS/DESIGN: This is a 3 centre, individual-level, single-blind, randomised controlled trial of the JCP compared with treatment as usual for people with a history of relapsing psychotic illness in Birmingham, London and Lancashire/Manchester. 540 service users will be recruited across the three sites. Eligible service users will be adults with a diagnosis of a psychotic disorder (including bipolar disorder), treated in the community under the Care Programme Approach with at least one admission to a psychiatric inpatient ward in the previous two years. Current inpatients and those subject to a community treatment order will be excluded to avoid any potential perceived pressure to participate. Research assessments will be conducted at baseline and 18 months. Following the baseline assessment, eligible service users will be randomly allocated to either develop a Joint Crisis Plan or continue with treatment as usual. Outcome will be assessed at 18 months with assessors blind to treatment allocation. The primary outcome is the proportion of service users treated or otherwise detained under an order of the Mental Health Act (MHA) during the follow-up period, compared across randomisation groups. Secondary outcomes include overall costs, service user engagement, perceived coercion and therapeutic relationships. Sub-analyses will explore the effectiveness of the JCP in reducing use of the MHA specifically for Black Caribbean and Black African service users (combined). Qualitative investigations with staff and service users will explore the acceptability of the JCPs.
DISCUSSION
JCPs offer a potential solution to the rise of compulsory treatment for individuals with psychotic disorders and, if shown to be effective in this trial, they are likely to be of interest to mental health service providers worldwide.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN11501328.
背景
在英国和其他国家,《精神卫生法》(MHA)下的强制治疗继续上升。联合危机计划(JCP)是一份服务使用者在未来精神健康危机时对治疗的意愿声明。它是与临床团队和独立协调员一起制定的。最近的一项试点 RCT 表明,对于有 JCP 的服务使用者,MHA 的使用有所减少。JCP 是唯一一种以这种方式显示减少强制治疗的干预措施。CRIMSON 试验旨在确定 JCP 是否与常规治疗相比,在英国的一系列治疗环境中,能有效减少 MHA 的使用。
方法/设计:这是一项在伯明翰、伦敦和兰开夏郡/曼彻斯特的 3 个中心进行的个体水平、单盲、随机对照试验,比较 JCP 与常规治疗对有反复发作精神病病史的人的效果。三个地点将招募 540 名服务使用者。符合条件的服务使用者将是成年人,他们被诊断患有精神病(包括双相情感障碍),在社区中根据关怀方案进行治疗,并且在过去两年中至少有一次入住精神病住院病房。目前的住院患者和受社区治疗令约束的患者将被排除在外,以避免任何潜在的参与压力。研究评估将在基线和 18 个月时进行。在基线评估后,符合条件的服务使用者将被随机分配制定联合危机计划或继续常规治疗。在 18 个月时进行结果评估,评估人员对治疗分配不知情。主要结果是在随访期间,与随机分组相比,接受治疗或根据《精神卫生法》(MHA)被拘留的服务使用者的比例。次要结果包括总费用、服务使用者参与度、感知强制和治疗关系。亚分析将探索 JCP 对减少特定于黑加勒比和黑非洲服务使用者(合并)的 MHA 使用的有效性。对工作人员和服务使用者进行的定性调查将探索 JCP 的可接受性。
讨论
JCP 为精神病患者的强制治疗上升提供了一个潜在的解决方案,如果在这项试验中证明有效,它们可能会引起全球精神卫生服务提供者的兴趣。
试验注册
当前对照试验 ISRCTN11501328。