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. 2025 Jul 31:86:103380.
doi: 10.1016/j.eclinm.2025.103380. eCollection 2025 Aug.

Examining the feasibility of a crisis-focused Cognitive Behaviour Therapy (CBT)-informed psychological intervention for inpatients experiencing psychosis (the CRISIS study): results from a pilot randomised controlled trial

Lisa Wood  1   2 , Anthony P Morrison  3   4 , Mary Birken  1 , Ceri Dare  1 , Ella Guerin  5 , Patrick Nyikavaranda  1   6 , Nira Malde-Shah  1 , Karen Persaud  1 , Panarai Ford  2 , Cyntheia Nebo  2 , Caroline S Clarke  7 , Brynmor Lloyd-Evans  1 , Kathryn Greenwood  8   9 , Glyn Lewis  1 , Barbara Lay  10 , Graeme MacLennan  11 , Nicola Morant  1 , Fiona Nolan  12 , Vanessa Pinfold  13 , Colette Christiansen  14 , Claire Williams  2 , Sonia Johnson  1   12
Affiliations

Examining the feasibility of a crisis-focused Cognitive Behaviour Therapy (CBT)-informed psychological intervention for inpatients experiencing psychosis (the CRISIS study): results from a pilot randomised controlled trial

Lisa Wood et al. EClinicalMedicine. .

Abstract

Background: 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.

Methods: 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.

Findings: 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.

Interpretation: 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.

Funding: This research was funded by the National Institute of Health Research (ICA-CL-2018-04-ST2-013).

Keywords: Cognitive Behaviour Therapy; Crisis; Mental health hospital; Psychosis; Randomised controlled trial.

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Conflict of interest statement

LW, APM, and CW are practicing CBTp researchers and clinicians. LW received funding from the NIHR (ICA-CL-2018-04-ST2-013) to undertake this research. SJ receives funding for research on crisis care from the National Institute for Research Policy Research Programme. GL receives funding from NIHR, including UCLH BRC, Wellcome Trust, Mental Health Research UK and for travel and subsistence for ECNP 2023. KG received grant funding as co-applicant from the WellcomeTrust for CONNECT study and the Better Sleep Study. KG completed a presentation on Combined Approaches to Schizophrenia Management: Pharmacological, Digital, and Psychosocial in the Boehringer Ingelheim industry session of the 36th ECNP Congress. She received honorarium for the presentation from Boehringer Ingelheim. KG is the Chair for the Data Monitoring and Ethics Committee board for Digital AVATAR therapy for distressing voices in psychosis: the phase 2/3 AVATAR2 trial.

Figures

Fig. 1
Fig. 1
CONSORT diagram of participant flow.
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