Wood Lisa, Morrison Anthony P, Birken Mary, Dare Ceri, Guerin Ella, Nyikavaranda Patrick, Malde-Shah Nira, Persaud Karen, Ford Panarai, Nebo Cyntheia, Clarke Caroline S, Lloyd-Evans Brynmor, Greenwood Kathryn, Lewis Glyn, Lay Barbara, MacLennan Graeme, Morant Nicola, Nolan Fiona, Pinfold Vanessa, Christiansen Colette, Williams Claire, Johnson Sonia
Division of Psychiatry, University College London, 149 Tottenham Court Road, London, W1T 7NF, UK.
North East London NHS Foundation Trust, Goodmayes Hospital, Barley Lane, Ilford, IG3 8XJ, UK.
EClinicalMedicine. 2025 Jul 31;86:103380. doi: 10.1016/j.eclinm.2025.103380. eCollection 2025 Aug.
Cognitive Behavioural Therapy for psychosis (CBTp) is a psychological intervention that should be offered in the acute phase of psychosis. However, there is little evidence to guide its delivery. The aim of this study was to examine the feasibility of a randomised controlled trial (RCT) of a crisis-focused CBTp-informed intervention (cCBTp) with inpatients. The intervention was co-produced with a stakeholder group.
Participants were included if they were experiencing psychosis and receiving care from a psychiatric inpatient service at the time of consent. We aimed to recruit n = 60 inpatients and randomise them on a 1:1 ratio to either receive cCBTp plus treatment as usual (TAU) or TAU alone. Follow-ups were conducted at 2, 6, and 12 months. An average of 6-8 sessions of the intervention were offered. The primary objective was to examine indicators of feasibility (recruitment, data collection rates, intervention delivery). The study was prospectively registered (ISRCTN59055607) and is now complete.
Between 1st February 2021 and 28th February 2022, 145 participants were referred to the study and 52 participants were randomised (during the COVID-19 pandemic). 26 were randomly allocated to cCBTp and 26 to TAU. We were able to recruit 87% of our target sample size. The face-to-face data collection rate (measures of symptoms, recovery, quality of life and service use) was 58% at 2 months and 60% at 6 months, which was below the proposed feasibility threshold. Collection of Electronic Health Record (EHR) data (relapse, rehospitalisation, and adverse events) was at 86% at 6 months and 83% at 12 months. Nine (35%) participants in the cCBTp arm and n = 7 (27%) in the TAU arm had an adverse or serious adverse event. None were assessed as related to participation in the intervention or the trial.
This study demonstrated that a pilot RCT of cCBTp was feasible with inpatients experiencing psychosis. A further large-scale fully powered trial is required to evaluate its effectiveness and cost-effectiveness, including modified strategies for follow-up data collection.
This research was funded by the National Institute of Health Research (ICA-CL-2018-04-ST2-013).
针对精神病的认知行为疗法（CBTp）是一种应在精神病急性期提供的心理干预措施。然而，几乎没有证据可指导其实施。本研究的目的是检验一项以危机为重点的、基于CBTp的干预措施（cCBTp）对住院患者进行随机对照试验（RCT）的可行性。该干预措施是与一个利益相关者团体共同制定的。
如果参与者在同意参与研究时正患有精神病且正在接受精神科住院服务，则将其纳入研究。我们的目标是招募n = 60名住院患者，并将他们按1:1的比例随机分配，分别接受cCBTp加常规治疗（TAU）或仅接受TAU。在2个月、6个月和12个月时进行随访。平均提供6 - 8次干预课程。主要目的是检验可行性指标（招募情况、数据收集率、干预实施情况）。该研究已进行前瞻性注册（ISRCTN59055607），现已完成。
在2021年2月1日至2022年2月28日期间，有145名参与者被转介至该研究，52名参与者被随机分组（在新冠疫情期间）。26人被随机分配至cCBTp组，26人被分配至TAU组。我们能够招募到目标样本量的87%。面对面数据收集率（症状、康复、生活质量和服务使用情况的测量）在2个月时为58%，在6个月时为60%，低于提议的可行性阈值。电子健康记录（EHR）数据（复发、再次住院和不良事件）在6个月时的收集率为86%，在12个月时为83%。cCBTp组有9名（35%）参与者，TAU组有7名（27%）参与者发生了不良或严重不良事件。没有事件被评估为与参与干预或试验有关。
本研究表明，对患有精神病的住院患者进行cCBTp的试点随机对照试验是可行的。需要进一步开展大规模、具备充分效力的试验来评估其有效性和成本效益，包括改进随访数据收集策略。
本研究由英国国家卫生研究院（ICA - CL - 2018 - 04 - ST2 - 013）资助。
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