Lisa Wood, Anthony P Morrison, Mary Birken, Ceri Dare, Ella Guerin, Patrick Nyikavaranda, Nira Malde-Shah, Karen Persaud, Panarai Ford, Cyntheia Nebo, Caroline S Clarke, Brynmor Lloyd-Evans, Kathryn Greenwood, Glyn Lewis, Barbara Lay, Graeme MacLennan, Nicola Morant, Fiona Nolan, Vanessa Pinfold, Colette Christiansen, Claire Williams, Sonia Johnson
{"title":"检查以危机为中心的认知行为疗法（CBT）知情心理干预住院精神病患者的可行性（危机研究）：来自一项随机对照试验的结果。","authors":"Lisa Wood, Anthony P Morrison, Mary Birken, Ceri Dare, Ella Guerin, Patrick Nyikavaranda, Nira Malde-Shah, Karen Persaud, Panarai Ford, Cyntheia Nebo, Caroline S Clarke, Brynmor Lloyd-Evans, Kathryn Greenwood, Glyn Lewis, Barbara Lay, Graeme MacLennan, Nicola Morant, Fiona Nolan, Vanessa Pinfold, Colette Christiansen, Claire Williams, Sonia Johnson","doi":"10.1016/j.eclinm.2025.103380","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Findings: </strong>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.</p><p><strong>Interpretation: </strong>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.</p><p><strong>Funding: </strong>This research was funded by the National Institute of Health Research (ICA-CL-2018-04-ST2-013).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"86 ","pages":"103380"},"PeriodicalIF":10.0000,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12337019/pdf/","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"Lisa Wood, Anthony P Morrison, Mary Birken, Ceri Dare, Ella Guerin, Patrick Nyikavaranda, Nira Malde-Shah, Karen Persaud, Panarai Ford, Cyntheia Nebo, Caroline S Clarke, Brynmor Lloyd-Evans, Kathryn Greenwood, Glyn Lewis, Barbara Lay, Graeme MacLennan, Nicola Morant, Fiona Nolan, Vanessa Pinfold, Colette Christiansen, Claire Williams, Sonia Johnson\",\"doi\":\"10.1016/j.eclinm.2025.103380\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Findings: </strong>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.</p><p><strong>Interpretation: </strong>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.</p><p><strong>Funding: </strong>This research was funded by the National Institute of Health Research (ICA-CL-2018-04-ST2-013).</p>\",\"PeriodicalId\":11393,\"journal\":{\"name\":\"EClinicalMedicine\",\"volume\":\"86 \",\"pages\":\"103380\"},\"PeriodicalIF\":10.0000,\"publicationDate\":\"2025-07-31\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12337019/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"EClinicalMedicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.eclinm.2025.103380\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/8/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"EClinicalMedicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.eclinm.2025.103380","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/8/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
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.
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).
期刊介绍：
eClinicalMedicine is a gold open-access clinical journal designed to support frontline health professionals in addressing the complex and rapid health transitions affecting societies globally. The journal aims to assist practitioners in overcoming healthcare challenges across diverse communities, spanning diagnosis, treatment, prevention, and health promotion. Integrating disciplines from various specialties and life stages, it seeks to enhance health systems as fundamental institutions within societies. With a forward-thinking approach, eClinicalMedicine aims to redefine the future of healthcare.
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