Eye movement desensitisation and reprocessing for post-traumatic stress in survivors of critical illness (EMERALD): a mixed-methods, randomised, single-blind, parallel group-controlled, feasibility trial.

Background: Eye movement desensitisation and reprocessing (EMDR) is a guideline-recommended treatment for post-traumatic stress disorder (PTSD), but evidence in survivors of critical illness remains limited. We assessed the feasibility, acceptability, and safety of EMDR for critical care survivors with clinically significant post-traumatic stress symptoms, and generated exploratory clinical outcome estimates to inform a future definitive trial. Methods: We conducted a mixed-methods, randomised, single-blind, parallel group-controlled, feasibility trial at three UK National Health Service hospitals. Adults (≥18 years) with an intensive care stay >24 h were approached before hospital discharge and followed within an observational cohort. At 2-3 months, participants were screened for post-traumatic stress symptoms (Impact of Event Scale-Revised); those scoring ≥22 were invited and randomly assigned (1:1) to EMDR plus treatment as usual (TAU) or TAU. EMDR comprised up to 16 sessions delivered face-to-face or online by accredited therapists. Primary outcomes were feasibility (recruitment, retention, intervention uptake, fidelity) and safety. Symptoms were assessed using Clinician-administered PTSD Scale for Diagnostic and Statistical Manual-5 (CAPS-5) at 3 and 12 months. Analyses followed intention-to-treat principles. The trial was registered on ClinicalTrials.gov (NCT05591625) and is closed to recruitment. Findings: Between Feb 20, 2023, and May 13, 2024, 160 patients were recruited to the observational cohort; 40 were randomised, with 20 allocated to EMDR plus TAU and 20 to TAU. Median age was 59.5 years (IQR 52.0-66.0); 21 participants (53%) were female and 19 (48%) were male. At 12 months, 39 (98%, 95% CI 86.8-99.9) of 40 randomised participants completed CAPS-5 follow-up. In the EMDR plus TAU group, 18 (90%, 95% CI 68.3-98.8) of 20 participants initiated treatment; mean sessions attended was 10.4 (SD 7.0), and 15 (75%) of 20 completed a full therapeutic course. Mean CAPS-5 score change was -15.6 (SD 12.5) in the EMDR plus TAU group and -1.6 (SD 11.8) in the TAU group, giving an exploratory unadjusted between-group difference of -14.1 points (95% CI -22.0 to -6.2). No treatment-related serious adverse events were identified. Interpretation: A staged trial pathway of symptom screening, clinician-rated PTSD assessment, randomisation, and EMDR delivery was feasible and broadly acceptable in survivors of critical illness with clinically significant post-traumatic stress symptoms. Exploratory clinician-rated PTSD outcome estimates were hypothesis-generating and support progression to a definitive multicentre trial, but should not be interpreted as evidence of treatment effectiveness. Funding: Andrew Bates was funded by National Institute for Health and Care Research Clinical Doctoral Research fellowship (grant number: NIHR302160).