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Authors
Rifkin-Zybutz, Raphael
Goldsmith, Kimberley
Kerr-Gaffney, Jess
Strawbridge, Rebecca
Kessler, David
Cleare, Anthony J
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Funding
Funding for this research was provided by:
National Institute for Health and Care Research (14/222/02)
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Article History
Received: 29 September 2025
Accepted: 20 December 2025
First Online: 28 February 2026
Declarations
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: RRZ has previously received grants from National Institute for Health and Care Research (NIHR). AJC reports grants from the UK Medical Research Council, ADM Protexin, NIHR, European Union Horizon Europe/Innovate UK, Beckley Psytech, and Wellcome Trust; consulting fees from Otsuka and Compass Pathways; and payment or honoraria for presentations or lectures from Janssen, Otsuka, Viatris, Compass Pathways, and Medscape; and is President of the International Society for Affective Disorders. JK-G owns shares in AstraZeneca and GSK. DK reports grant funding from the NIHR (RP-PG-0514–20012, INTERACT); has received payment from the Royal College of General Practitioners for a presentation; and sits on advisory boards for NIHR-funded studies. KG reports grants from the UK Medical Research Council, the NIHR, and US National Institutes of Health. RS reports an Honoraria for Janssen. JK-G owns shares in AstraZeneca and GSK. LM and RWT are current employees of Compass Pathways and hold shares or options in Compass Pathways. KG reports grants from the UK Medical Research Council, the NIHR, and US National Institutes of Health. All other authors declare no competing interests.
: People with lived experience were involved in designing (providing feedback on the protocol and patient-facing documents) and running the trial (providing feedback on recruitment methods and participating as members of the trial steering committee). The trial received a favourable opinion from the East of England–Cambridge South Research Ethics Committee and was approved by the Health Research Authority and the Medicines and Healthcare products Regulatory Agency (EudraCT 2016–001637–27). The trial was preregistered on the International Standard Randomised Controlled Trial registry, (ISRCTN16387615). The statistical analysis plan for this secondary analysis was preregistered on the Open Science Framework ( ).
