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.

Abstract

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. 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. 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. 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. Andrew Bates was funded by National Institute for Health and Care Research Clinical Doctoral Research fellowship (grant number: NIHR302160).