Introduction Trauma can play an important role in the development of psychosis, yet no studies have investigated whether a trauma-focused psychological therapy could prevent the onset of psychosis in people at high risk of developing this condition. This study aims to establish whether it would be feasible to conduct a multicentre randomised controlled trial (RCT) to investigate the clinical and cost-effectiveness of eye movement desensitisation and reprocessing (EMDR) therapy to prevent the onset of psychosis in people with an at-risk mental state (ARMS).
Methods/analysis This is a single-arm trial with a nested qualitative study where all participants (target n=20) will be offered EMDR. Eligible participants are those who meet criteria for ARMS; have experienced a traumatic event before the onset of ARMS symptomatology; and have at least one symptom of post-traumatic stress disorder (PTSD). Participants will be followed up at 4, 8 and 12 months after the baseline assessment. The primary outcome measure is transition to psychosis, and secondary outcome measures include severity of psychotic symptoms, PTSD, depression, anxiety, impaired functioning, health status and resource use. The analysis will aim to establish the rates of recruitment and retention for a large-scale RCT. Interviews with therapists and patients will explore their views of the study and their experiences of delivering or receiving EMDR.
Ethics and dissemination This protocol has been approved by the South West-Cornwall and Plymouth Research Ethics Committee (Reference 18/SW/0037). Findings will be disseminated through journal publications, conference presentations and meetings with service users, their families, mental health professionals and commissioners.
Trial registration number ISRCTN31976295.
- schizophrenia & psychotic disorders
- qualitative research
- clinical trials
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Contributors SZ, NW, KMT and DS designed the study. SZ is the grant holder and chief investigator. SZ, NW and KMT oversaw the scientific rigour of the study. NW provided expertise in the management and analysis of the study. KMT oversaw the nested qualitative study. DS coordinated, implemented and ran the trial. CD assisted with running the trial. All authors contributed to refinement of the study protocol and approved the final manuscript.
Funding This study was funded by the NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust (BRC-1215-20011) and the University of Bristol. The sponsor of the study is the University of Bristol.
Disclaimer The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health. The sponsor and study funders had no authority over the running of the trial, and all decisions rest with the trial team.
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
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