Wood Lisa, Williams Claire, Pinfold Vanessa, Nolan Fiona, Morrison Anthony P, Morant Nicola, Lloyd-Evans Brynmor, Lewis Glyn, Lay Barbara, Jones Rebecca, Greenwood Kathryn, Johnson Sonia
Division of Psychiatry, University College London, 149 Tottenham Court Road, London, W1T 7NF, UK.
Acute and Rehabilitation Directorate, North East London NHS Foundation Trust, Goodmayes Hospital, Barley Lane, Ilford, IG3 8XJ, UK.
Pilot Feasibility Stud. 2022 Sep 10;8(1):205. doi: 10.1186/s40814-022-01160-7.
Cognitive Behavioural Therapy for psychosis (CBTp) has an established evidence base and is recommended by clinical guidelines to be offered during the acute phases of psychosis. However, few research studies have examined the efficacy of CBTp interventions specifically adapted for the acute mental health inpatient context with most research trials being conducted with white European community populations.
The aim of this study is to conduct a pilot randomised controlled trial (RCT), which incorporates the examination of feasibility markers, of a crisis-focused CBTp intervention adapted for an ethnically diverse acute mental health inpatient population, in preparation for a large-scale randomised controlled trial. The study will examine the feasibility of undertaking the trial, the acceptability and safety of the intervention and the suitability of chosen outcome measures. This will inform the planning of a future, fully powered RCT.
A single-site, parallel-group, pilot RCT will be conducted examining the intervention. Drawing on principles of coproduction, the intervention has been adapted in partnership with key stakeholders: service users with lived experience of psychosis and of inpatient care (including those from ethnic minority backgrounds), carers, multi-disciplinary inpatient clinicians and researchers. Sixty participants with experience of psychosis and in current receipt of acute mental health inpatient care will be recruited. Participants will be randomly allocated to either the crisis-focused CBTp intervention or treatment as usual (TAU).
Findings of this pilot RCT will indicate whether a larger multi-site RCT is needed to investigate the efficacy of the intervention. If the initial results demonstrate that this trial is feasible and the intervention is acceptable, it will provide evidence that a full-scale effectiveness trial may be warranted.
This trial has been prospectively registered on the ISRCTN registry ( ISRCTN59055607 ) on the 18th of February 2021.
针对精神病的认知行为疗法（CBTp）已有既定的证据基础，临床指南建议在精神病急性期提供该疗法。然而，很少有研究考察专门针对急性心理健康住院环境调整的CBTp干预措施的疗效，大多数研究试验是在欧洲白人社区人群中进行的。
本研究的目的是开展一项试点随机对照试验（RCT），该试验将对一项针对不同种族的急性心理健康住院人群调整的、以危机为重点的CBTp干预措施进行可行性指标检查，为大规模随机对照试验做准备。该研究将考察进行试验的可行性、干预措施的可接受性和安全性以及所选结局指标的适用性。这将为未来一项充分有力的RCT的规划提供信息。
将进行一项单中心、平行组试点RCT来考察该干预措施。借鉴共同生产原则，该干预措施已与关键利益相关者合作进行了调整：有精神病和住院护理经历的服务使用者（包括来自少数族裔背景的人）、护理人员、多学科住院临床医生和研究人员。将招募60名有精神病经历且目前正在接受急性心理健康住院护理的参与者。参与者将被随机分配到以危机为重点的CBTp干预组或常规治疗（TAU）组。
这项试点RCT的结果将表明是否需要进行更大规模的多中心RCT来研究该干预措施的疗效。如果初步结果表明该试验可行且干预措施可接受，将提供证据表明可能有必要进行全面的有效性试验。
该试验已于2021年2月18日在ISRCTN注册库（ISRCTN59055607）上进行了前瞻性注册。
