Lobban Fiona, Gamble Carol, Kinderman Peter, Taylor Lee, Chandler Claire, Tyler Elizabeth, Peters Sarah, Pontin Eleanor, Sellwood William, Morriss Richard K
School of Psychological Sciences, Faculty of Medical and Human Sciences, University of Manchester, Manchester, UK.
BMC Psychiatry. 2007 Feb 2;7:6. doi: 10.1186/1471-244X-7-6.
Bipolar Disorder (BD) is a common and severe form of mental illness characterised by repeated relapses of mania or depression. Pharmacotherapy is the main treatment currently offered, but this has only limited effectiveness. A recent Cochrane review has reported that adding psycho-social interventions that train people to recognise and manage the early warning signs of their relapses is effective in increasing time to recurrence, improving social functioning and in reducing hospitalisations. However, the review also highlights the difficulties in offering these interventions within standard mental health services due to the need for highly trained therapists and extensive input of time. There is a need to explore the potential for developing Early Warning Sign (EWS) interventions in ways that will enhance dissemination.
This article describes a cluster-randomised trial to assess the feasibility of training care coordinators (CCs) in community mental health teams (CMHTs) to offer Enhanced Relapse Prevention (ERP) to people with Bipolar Disorder. CMHTs in the North West of England are randomised to either receive training in ERP and to offer this to their clients, or to continue to offer treatment as usual (TAU). The main aims of the study are (1) to determine the acceptability of the intervention, training and outcome measures (2) to assess the feasibility of the design as measured by rates of recruitment, retention, attendance and direct feedback from participants (3) to estimate the design effect of clustering for key outcome variables (4) to estimate the effect size of the impact of the intervention on outcome. In this paper we provide a rationale for the study design, briefly outline the ERP intervention, and describe in detail the study protocol.
This information will be useful to researchers attempting to carry out similar feasibility assessments of clinical effectiveness trials and in particular cluster randomised controlled trials.
双相情感障碍（BD）是一种常见且严重的精神疾病，其特征为躁狂或抑郁反复发作。药物治疗是目前主要的治疗方式，但效果有限。最近一项Cochrane综述报告称，增加心理社会干预措施，即训练人们识别并管理复发的早期预警信号，对于延长复发时间、改善社会功能以及减少住院次数是有效的。然而，该综述也强调了在标准心理健康服务中提供这些干预措施存在困难，因为需要训练有素的治疗师且投入大量时间。有必要探索以促进传播的方式开发早期预警信号（EWS）干预措施的潜力。
本文描述了一项整群随机试验，以评估培训社区心理健康团队（CMHTs）中的护理协调员（CCs），为双相情感障碍患者提供强化预防复发（ERP）的可行性。英格兰西北部的CMHTs被随机分为两组，一组接受ERP培训并向其客户提供该服务，另一组继续照常提供治疗（TAU）。该研究的主要目的是：（1）确定干预措施、培训及结果测量的可接受性；（2）通过招募率、保留率、出勤率以及参与者的直接反馈来评估设计的可行性；（3）估计关键结果变量的聚类设计效应；（4）估计干预措施对结果的影响大小。在本文中，我们为研究设计提供了理论依据，简要概述了ERP干预措施，并详细描述了研究方案。
这些信息对于试图对临床疗效试验，尤其是整群随机对照试验进行类似可行性评估的研究人员将是有用的。
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