Multisite randomised controlled trial of trauma-focused cognitive behaviour therapy for psychosis to reduce post-traumatic stress symptoms in people with co-morbid post-traumatic stress disorder and psychosis, compared to treatment as usual:study protocol for the STAR (Study of Trauma And Recovery) trial

• Peters, Emmanuelle
• Hardy, Amy
• Dudley, Robert https://orcid.org/0000-0002-3765-9998
• Varese, Filippo
• Greenwood, Kathryn
• Steel, Craig
• Emsley, Richard
• Keen, Nadine
• Bowe, Samantha
• Swan, Sarah
• Underwood, Raphael
• Longden, Eleanor
• Byford, Sarah
• Potts, Laura (laura.potts@york.ac.uk)
• Heslin, Margaret
• Grey, Nick
• Turkington, Doug
• Fowler, David
• Kuipers, Elizabeth
• Morrison, Anthony

Funding Information: We would like to thank the experts-by-experience in the Manchester Service User Research Group and the South London Psychological Interventions Clinic for outpatients with Psychosis (PICuP) Peer Supporters, who have provided advice in terms of highlighting the need for the research, the design of the trial, the measures selected, and procedures for the conduct of the screening and assessments. We acknowledge the Clinical Research Network for support in identification and recruitment of participants. RE is part funded by the National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King’s College London, and NIHR Research Professorship, NIHR300051). EL and FV are funded by an NIHR Post-Doctoral Fellowship (PDF-2017-10-050) and Advanced Fellowship (NIHR300850), respectively. EP is the PI of the study. She took responsibility for the main drafting of the protocol and made substantial contributions to conception and design. AH, RD, FV, KG, CS, and AM took responsibility for the drafting of the protocol and made substantial contributions to conception and design. NK, AH, SB, NG, RD, and CS took responsibility and made substantial contributions to the design and development of the clinical intervention and therapy fidelity. RE is accountable for the statistical plan and analyses and made substantial contributions to conception and design. SB and MH took responsibility and are accountable for the design and analysis of the economic evaluation. EL took responsibility and is accountable for the qualitative interviews design and analyses. RU and SS are the Trial Coordinators and contributed to the development of the trial protocol. DF, DT, and EK are collaborators on the study and made substantial contributions to conception and design. All authors have been involved in drafting the protocol or revising it critically for important intellectual content. All authors read and approved the final protocol. This trial is funded by NIHR (HTA), NIHR128623. The Funder reviewed and approved the content of the protocol, but does not have a role in data collection, management, analysis, or interpretation; nor in the writing of the final report or decision to submit the report. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. The Investigator(s) will permit trial-related monitoring, audits, and REC review by providing the Sponsor(s), the DMEC, and REC direct access to source data and other documents as required. An anonymised version of the main outcome data and the corresponding statistical code will be available from the trial team on reasonable request after publication of the main results paper. Funding Information: This trial is funded by NIHR (HTA), NIHR128623. The Funder reviewed and approved the content of the protocol, but does not have a role in data collection, management, analysis, or interpretation; nor in the writing of the final report or decision to submit the report. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. Funding Information: We would like to thank the experts-by-experience in the Manchester Service User Research Group and the South London Psychological Interventions Clinic for outpatients with Psychosis (PICuP) Peer Supporters, who have provided advice in terms of highlighting the need for the research, the design of the trial, the measures selected, and procedures for the conduct of the screening and assessments. We acknowledge the Clinical Research Network for support in identification and recruitment of participants. RE is part funded by the National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King’s College London, and NIHR Research Professorship, NIHR300051). EL and FV are funded by an NIHR Post-Doctoral Fellowship (PDF-2017-10-050) and Advanced Fellowship (NIHR300850), respectively. Publisher Copyright: © 2022, The Author(s).

• Published: 23 May 2022
• Accepted: 26 March 2022

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