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Cognitive Behavioural Therapy for Psychosis BMJ Open: first published as 10.1136/bmjopen-2019-035062 on 28 May 2021. Downloaded from BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay-per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] http://bmjopen.bmj.com/ on September 26, 2021 by guest. Protected copyright. BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-035062 on 28 May 2021. Downloaded from For whom is Cognitive Behavioural Therapy (CBT) for psychosis most effective? Protocol for an IPD meta-analysis of randomised control trials comparing CBT versus standard care and other psychosocial interventions (Cognitive Behaviour Therapy for Psychosis: Individual Modifiers of ForPatient peer Response review to Treatment) only Journal: BMJ Open Manuscript ID bmjopen-2019-035062 Article Type: Protocol Date Submitted by the 17-Oct-2019 Author: Complete List of Authors: Sudell, Maria; University of Liverpool, Department of Biostatistics, Institute of Translational Medicine Tudur-Smith, Catrin; University of Liverpool, Biostatistics Liao, Xiaomeng; University of Liverpool, Department of Biostatistics, Institute of Translational Medicine Longden, Eleanor; Greater Manchester West Mental Health NHS Foundation Trust Dunn, Graham; University of Manchester, Health Methodology Research http://bmjopen.bmj.com/ Kendall, Tim; National Collaborating Centre for Mental Health Emsley, Richard; King’s College London, Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience Morrison, Anthony; University of Manchester Varese, Filippo; Manchester Academic Health Science Centre, Keywords: IPD-MA, Treatment Modifier, CBT, Psychosis on September 26, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 24 BMJ Open 1 2 3 4 BMJ Open: first published as 10.1136/bmjopen-2019-035062 on 28 May 2021. 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Where the Submitting Author wishes to make the Work available on an Open Access basis (and 21 intends to pay the relevant APC), the terms of reuse of such Open Access shall be governed by a Creative 22 Commons licence – details of these licences and which Creative Commons licence will apply to this Work are set 23 out in our licence referred to above. 24 25 Other than as permitted in any relevant BMJ Author’s Self Archiving Policies, I confirm this Work has not been 26 accepted for publication elsewhere, is not being considered for publication elsewhere and does not duplicate 27 material already published. I confirm all authors consent to publication of this Work and authorise the granting 28 of this licence. 29 30 31 32 33 34 35 36 http://bmjopen.bmj.com/ 37 38 39 40 41 42 43 44 on September 26, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 24 1 2 3 4 BMJ Open: first published as 10.1136/bmjopen-2019-035062 on 28 May 2021. Downloaded from 5 For whom is Cognitive Behavioural Therapy (CBT) for 6 7 8 9 psychosis most effective? Protocol for an IPD meta-analysis of 10 11 12 randomised control trials comparing CBT versus standard care 13 14 15 16 and other psychosocial interventions (Cognitive Behaviour 17 18 For peer review only 19 Therapy for Psychosis: Individual Modifiers of Patient 20 21 22 23 Response to Treatment) 24 25 26 Maria Sudell1,a*, Catrin Tudur Smith1,b, Xiaomeng Liao1,c, Eleanor Longden3,d, Graham Dunn4, 27 28 Tim Kendall5, 6,e, Richard Emsley7,f & Anthony P. Morrison2,3,g Filippo Varese2,3,h 29 30 1Institute of Translational Medicine, University of Liverpool; 2School of Health Sciences, 31 32 Division of Psychology and Mental Health, Faculty of Biology Medicine and Health, University 33 3 34 of Manchester; Greater Manchester Mental Health NHS Mental Health Foundation Trust; 35 4Institute of Population Health, University of Manchester; 5National Collaborating Centre for 36 http://bmjopen.bmj.com/ 37 Mental Health; 6Sheffield Health and Social Care NHS Foundation Trust; 7Department of 38 39 Biostatistics & Health Informatics, Kings College London; [email protected]; 40 41 [email protected]; [email protected]; [email protected]; 42 e f 43 [email protected]; [email protected]; 44 g h on September 26, 2021 by guest. Protected copyright. 45 [email protected] ; [email protected]; 46 *Corresponding author 47 48 49 University of Manchester 50 Division of Psychology and Mental Health 51 52 School of Health Sciences 53 Zochonis Building, 2nd floor; room 2.40 54 Manchester 55 M13 9PL 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 24 BMJ Open 1 2 3 4 Article Summary BMJ Open: first published as 10.1136/bmjopen-2019-035062 on 28 May 2021. Downloaded from 5 6 7 8 Introduction: Aggregate data meta-analyses have shown heterogeneous treatment effects 9 10 for Cognitive Behavioural Therapy (CBT) for patients with schizophrenia-spectrum 11 12 diagnoses. This heterogeneity could stem from specific intervention or patient 13 characteristics that could influence the clinical effectiveness of CBT, termed treatment 14 15 effect modifiers. This Individual Participant Data Meta-Analysis (IPD-MA) will investigate a 16 17 range of potential treatment effect modifiers of the efficacy CBT. Methods and analysis: We 18 For peer review only 19 will perform a systematic review and meta-analysis of studies investigating CBT vs treatment 20 21 as usual (TAU), or CBT vs other psychosocial interventions, for patients with schizophrenia- 22 spectrum diagnoses. The Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, 23 24 EMBASE and the online clinical trials registers of the US government, European Union, 25 26 World Health Organization and Current Controlled Trials Ltd will be searched. Two 27 28 researchers will screen titles and abstracts identified by the search. Individual participant 29 30 data will be requested for any eligible study, for the primary outcome (overall psychotic 31 32 symptoms), secondary outcomes and treatment effect modifiers. Data will be checked and 33 recoded according to an established Statistical Analysis Plan. One and two-stage random 34 35 effects meta-analyses investigating potential treatment effect modifiers will be conducted. 36 http://bmjopen.bmj.com/ 37 A list of potential treatment effect modifiers for CBT will be produced, motivating future 38 39 research into particular modifiers. Ethics and dissemination: This study does not require 40 41 ethical approval as it is based on data from existing studies, although best ethical practice 42 43 for secondary analysis of clinical data will be followed. The findings will be submitted for 44 publication in peer-reviewed journals, and promoted to relevant stakeholders. on September 26, 2021 by guest. Protected copyright. 45 46 47 48 Prospero registration number 15/187/05 49 50 51 Strengths and Limitations of study 52 53 54 This will be the first published IPD-MA to investigate treatment effect modifiers for 55 56 CBT for patients with schizophrenia-spectrum diagnoses 57 The review will consider the efficacy of CBTp across multiple outcomes of interest in 58 59 addition to psychotic symptoms severity 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 24 1 2 3 The search will be conducted without geographical, language or time restrictions 4 BMJ Open: first published as 10.1136/bmjopen-2019-035062 on 28 May 2021. Downloaded from 5 A potential limitation of this study will be the degree of heterogeneity between 6 7 studies in recorded measures and scales employed.
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