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A service of the National Library of Medicine, National Institutes of Health. < Prev Next > Treatment effect modifiers of cognitive behaviour therapy in people with psychosis: an individual participant data meta-analysis of RCTs Health Technology Assessment, No. 29.53 Filippo Varese , Maria Sudell , Anthony P Morrison , Eleanor Longden , and Catrin Tudur Smith ; on behalf of the IMPART. Author Information and Affiliations Authors Filippo Varese , 1,2 ,* Maria Sudell , 3 Anthony P Morrison , 1,2 Eleanor Longden , 1,2 and Catrin Tudur Smith 3 ; on behalf of the IMPART. Affiliations 1 Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, Zochonis Building, University of Manchester, Manchester, UK 2 Greater Manchester Mental Health NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, Research & Innovation Office, Prestwich, Manchester, UK 3 Institute of Population Health, University of Liverpool, Liverpool, UK * Corresponding author ; Email: [email protected] Southampton (UK): National Institute for Health and Care Research ; 2025 Nov . Copyright and Permissions Copyright © 2025 Varese et al. This work was produced by Varese et al . under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/ . For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited. Search term Abstract Background: Cognitive–behavioural therapy is a recommended intervention for the treatment of schizophrenia and related psychoses, but there is considerable uncertainty on whether its effectiveness is moderated by patient characteristics and/or intervention characteristics. Objective(s): To identify treatment effect modifiers of cognitive–behavioural therapy in people with schizophrenia spectrum diagnoses. Design: An individual participant data meta-analysis of randomised controlled trials comparing cognitive–behavioural therapy to treatment as usual or control active psychosocial control interventions. Setting: Community and inpatient settings. Participants: Individuals with schizophrenia spectrum diagnoses. Interventions: Cognitive–behavioural therapy, as defined by the criteria outlined in the National Institute for Health and Care Excellence guideline on treatment and management of schizophrenia in adults. Main outcome measures: Overall symptom change as measured by assessments of overall psychotic symptom severity (e.g. the Positive and Negative Syndrome Scales). Data sources: Corresponding authors of 110 trials identified from the database searches conducted as part of a related aggregate data meta-analysis in February 2018 (later updated in January 2019) were invited to share their trials’ individual participant data, and additional trial documentation, when available, pertaining to relevant individual participant data metadata, statistical analyses plans and characteristics of the cognitive–behavioural therapy interventions evaluated in their eligible trials. Review methods: Reports of retrieved and unretrieved trials were assessed using the Cochrane Risk of Bias tool. Data were cleaned and standardised to allow pooling and analysis. We conducted a series of two-stage individual participant data random-effect meta-analyses across four treatment comparisons: cognitive–behavioural therapy versus treatment as usual; cognitive–behavioural therapy versus other psychosocial interventions/active comparisons (active control psychosocial interventions); cognitive–behavioural therapy integrating additional elements from other therapies (‘cognitive–behavioural therapy+’) versus treatment as usual; and cognitive–behavioural therapy+ versus active control psychosocial interventions. Treatment by covariate interaction analyses were carried out to examine potential treatment effect modifiers, including participants’ demographic characteristics (age, gender, ethnicity), clinical characteristics (illness duration, phase of illness, duration of untreated psychosis, initial severity of psychotic symptoms and affective symptoms), and specific intervention characteristics (treatment duration, number of therapy sessions, level of therapists’ training/competence, use of manualised interventions, formulation-based interventions; individual vs. group interventions). Results: A total of 53 trials were retrieved. Of these, 27 trials ( n = 2870) were available for the planned cognitive–behavioural therapy versus treatment as usual primary outcome analyses, 11 trials ( n = 961) for the cognitive–behavioural therapy versus active control psychosocial interventions analyses, 14 trials ( n = 1985) for cognitive–behavioural therapy+ versus treatment as usual analyses, and 3 trials ( n = 28) for the cognitive–behavioural therapy+ versus active control psychosocial interventions analyses. There was no reliable evidence indicating that any of the covariates considered in this evidence synthesis significantly impacted the efficacy of cognitive–behavioural therapy in this client group. Limitations: Only 54% of the individual participant data requested were provided by data owners, and there is considerable heterogeneity in the features of the cognitive–behavioural therapy interventions included in this evidence synthesis. Conclusions: The effectiveness of cognitive–behavioural therapy for overall symptom change in this patient group is not significantly affected by the covariates examined in this individual participant data meta-analysis. Cognitive–behavioural therapy should continue to be offered equally to service users irrespective of their demographic or clinical characteristics. Future work: Other potential avenues to explore moderators of cognitive–behavioural therapy efficacy are suggested, including the fine-grained analysis of specific intervention components and the added value of interventionist-causal paradigms. Study registration: This study is registered as PROSPERO CRD42017060068. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme ( NIHR award ref: 15/187/05) and is published in full in Health Technology Assessment ; Vol. 29, No. 53. See the NIHR Funding and Awards website for further award information. Plain language summary Psychosis, a mental health condition which can include experiences such as unusual beliefs and hearing voices, can cause great distress and be very difficult to cope with. Treatment guidelines in the United Kingdom and abroad recommend cognitive–behavioural therapy, a type of talking therapy that supports people with psychosis to change the way they think about and react to their experiences. However, while research has shown that cognitive–behavioural therapy can reduce psychosis symptoms for some people, its effectiveness seems to be mixed. For example, some studies show cognitive–behavioural therapy is very useful for psychosis patients, while others find it has little impact compared to other types of mental health support. Some of the differences found in these studies could be explained by the types of participants who took part in them (e.g. their age, gender, ethnicity and how challenging their mental health difficulties are). Another explanation might be the type of cognitive–behavioural therapy they received (e.g. how many therapy sessions they had, or whether they were offered group therapy or individual appointments). Understanding more about these differences can help to explain who cognitive–behavioural therapy is most helpful for. We therefore invited researchers from across the world to share their results from these studies with us so we could look at them in more detail. We then combined the results together to see (1) if there are groups of patients who are more likely to benefit from cognitive–behavioural therapy, and (2) if there are ways of running cognitive–behavioural therapy sessions which are more effective. However, our findings suggest that the types of participants, and the types of cognitive–behavioural therapy, did not affect how helpful cognitive–behavioural therapy can be. In line with current treatment guidelines, this shows that people with psychosis should continue to be offered cognitive–behavioural therapy no matter what their social or mental health background is. Contents Expand All Collapse All Scientific summary Chapter 1. Introduction Background Primary objective Secondary objectives Chapter 2. Methods Protocol and registration Identification of trials for inclusion Data collection Primary outcome Treatment comparisons Treatment effect modifiers Data standardisation Statistical methods for the analysis of primary outcome (Positive and Negative Syndrome Scale) Chapter 3. Results Identification of trials for inclusion in the project Characteristics of the included trials Assessment of risk of bias in the included trials Comparison of included and excluded trials Total sample size across the planned treatment comparisons Primary outcome analysis (Positive and Negative Syndrome Scale): cognitive–behavioural therapy versus treatment as usual trials Primary outcome analysis (Positive and Negative Syndrome Scale): cognitive–behavioural therapy versus active control trials Primary outcome analysis (Positive and Negative Syndrome Scale): cognitive–behavioural therapy plus additional elements of other therapies versus treatment as usual trials Primary outcome analyses (Positive and Negative Syndrome Scale): cognitive–behavioural therapy plus additional elements of other therapies versus other psychosocial intervention active control trials Chapter 4. Discussion/interpretation Chapter 5. Patient and public involvement Chapter 6. Equality, diversity and inclusion Chapter 7. Impact and learning Chapter 8. Implications for decision makers Chapter 9. Research recommendations Chapter 10. Conclusions Additional information References Appendix 1. Full list of trials approached for inclusion in the IMPART project Appendix 2. List and sample size of trials not included in the IMPART project Appendix 3. Full scores of the risk of bias assessment for the 50 trials included in the CBTp IMPART analyses Appendix 4. Full scores of the risk of bias assessment for the 60 trials not included in the CBTp IMPART analyses Appendix 5. Sample size breakdown across the planned treatment comparisons Appendix 6. Funnel plot for the cognitive–behavioural therapy versus treatment as usual main treatment effect Appendix 7. Descriptive statistics of treatment effect modifiers tested for the cognitive–behavioural therapy versus treatment as usual treatment comparison Appendix 8. Descriptive statistics of treatment effect modifiers tested for the cognitive–behavioural therapy versus active control treatment comparison Appendix 9. Descriptive statistics of treatment effect modifiers tested for the cognitive–behavioural therapy plus additional elements of other therapies versus treatment as usual treatment comparison Appendix 10. Descriptive statistics of treatment effect modifiers tested for the cognitive–behavioural therapy plus additional elements of other therapies versus active control treatment comparison List of abbreviations List of supplementary material Expand All Collapse All About the Series Health Technology Assessment ISSN (Electronic): 2046-4924 Article history The research reported in this issue of the journal was funded by the HTA programme as award number HTA 15/187/05. The contractual start date was in June 2017. The draft manuscript began editorial review in October 2020 and was accepted for publication in March 2024. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ manuscript and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this article. Last reviewed: October 2020; Accepted: March 2024. Copyright © 2025 Varese et al . This work was produced by Varese et al . under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/ . For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited. Bookshelf ID: NBK618904 DOI: 10.3310/NCFR5074 < Prev Next > Share Views PubReader Print View Cite this Page Varese F, Sudell M, Morrison AP, et al. Treatment effect modifiers of cognitive behaviour therapy in people with psychosis: an individual participant data meta-analysis of RCTs. Southampton (UK): National Institute for Health and Care Research; 2025 Nov. (Health Technology Assessment, No. 29.53.) doi: 10.3310/NCFR5074 PDF version of this title (2.7M) Other titles in this collection Health Technology Assessment Related information NLM Catalog Related NLM Catalog Entries Similar articles in PubMed Folic acid supplementation and malaria susceptibility and severity among people taking antifolate antimalarial drugs in endemic areas. 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