McIntosh Lindsey G, Slesser Morag, O'Rourke Suzanne, Thomson Lindsay D G
1Division of Psychiatry, University of Edinburgh, Edinburgh, EH14 5HF UK.
The State Hospitals Board for Scotland, Carstairs, ML11 8RP UK.
Pilot Feasibility Stud. 2018 Jul 13;4:124. doi: 10.1186/s40814-018-0319-z. eCollection 2018.
(OTRTR) is a brief low intensity group psychological therapy that aims to improve patients' insight into their mental disorder and develop adaptive coping skills to help manage distress. OTRTR is currently delivered in forensic mental health services in Scotland. However, to date, this therapy has not been evaluated as to its effectiveness or safety for forensic patients.
This is a parallel-group feasibility randomized controlled trial with single-blind assessments comparing OTRTR therapy to treatment as usual (TAU) for forensic mental health patients. Fifty participants will be recruited from high, medium, and low secure forensic mental health services in Scotland. Participants will receive OTRTR for approximately 12 weeks or continue treatment as usual for 12 weeks. The trial's primary aims relate to testing the acceptability and feasibility of key trial procedures that would be necessary for a definitive RCT of OTRTR. The secondary aims include estimating therapeutic effect sizes on clinical outcomes including insight and coping skills. The study design also features an adverse event monitoring plan to estimate the safety of OTRTR for participants, as well as use of intensive longitudinal methods to identify "key ingredients" to the OTRTR therapy protocol.
This study will inform the design and sample size for a future full-scale randomized controlled trial (RCT), which will be conducted to determine the effectiveness of the intervention in improving forensic mental health patients' clinical insight and coping skills.
ISRCTN Registry, ISRCTN75126867 registered 27 July 2017.
（OTRTR）是一种简短的低强度团体心理治疗方法，旨在提高患者对其精神障碍的洞察力，并培养适应性应对技能以帮助管理痛苦。目前，OTRTR在苏格兰的法医精神健康服务中提供。然而，迄今为止，尚未对这种疗法的有效性或对法医患者的安全性进行评估。
这是一项平行组可行性随机对照试验，采用单盲评估，将OTRTR疗法与法医精神健康患者的常规治疗（TAU）进行比较。将从苏格兰高、中、低安全级别的法医精神健康服务机构招募50名参与者。参与者将接受约12周的OTRTR治疗，或继续接受12周的常规治疗。该试验的主要目的是测试OTRTR确定性随机对照试验所需的关键试验程序的可接受性和可行性。次要目的包括估计对包括洞察力和应对技能在内的临床结果的治疗效果大小。该研究设计还包括一个不良事件监测计划，以评估OTRTR对参与者的安全性，以及使用密集纵向方法来确定OTRTR治疗方案的“关键要素”。
本研究将为未来的全面随机对照试验（RCT）的设计和样本量提供信息，该试验将进行以确定该干预措施在改善法医精神健康患者的临床洞察力和应对技能方面的有效性。
ISRCTN注册中心，ISRCTN75126867，于2017年7月27日注册。
