Adding virtual reality to talking therapy for post-traumatic stress disorder: a feasibility study

INTERVENTION: Participants are randomised 1:1 to the intervention or control group using permuted block randomisation with varying block sizes. The randomisation sequence is managed through a secure, central online randomisation service to ensure allocation concealment. Control Group: Participants receive 6 weekly sessions of standard in‐person Eye Movement Desensitization and Reprocessing (EMDR) therapy delivered by a qualified clinician Intervention Group: Participants receive standard weekly in‐person EMDR therapy combined with a fixed 3‐week home‐use block. During this block, participants self‐administer a 40–50 minute adjunctive trauma processing session every other day (targeting 3–4 sessions per week) utilising the Psylaris EMDR‐VR medical device. CONDITION: Post‐traumatic stress disorder (PTSD) ; Mental and Behavioural Disorders PRIMARY OUTCOME: Feasibility adherence rate measured using the proportion of prescribed home‐use sessions successfully completed, extracted objectively via the VR software's internal logs at continuously monitored over the 3‐week active home‐use block (assessed at week 6 end of treatment) SECONDARY OUTCOME: Clinical efficacy (comorbidities) measured using the Patient Health Questionnaire‐9 (PHQ‐9) for depression and Generalized Anxiety Disorder‐7 (GAD‐7) for anxiety at baseline (week 1), midpoint (week 3/VR start), and end of treatment (week 6) Clinical efficacy (PTSD severity) measured using the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition PTSD Checklist (DSM‐5 PCL‐5) score at baseline (week 1), midpoint (week 3/VR start), and end of treatment (week 6) Safety profile measured using the incidence and frequency of adverse device effects (ADEs) at tracked continuously throughout the 6‐week trial duration Usability/acceptability measured using the System Usability Scale (SUS) and User Experience Questionnaire ‐ Short Version (UEQ‐S) at week 6 post‐treatment (intervention group only) INCLUSION CRITERIA: 1. Capable of giving informed consent 2. Male or female adults aged 18 years or over 3. Primary diagnosis of post‐traumatic stress disorder (PTSD) (relating to single‐event or multiple/comple Xtrauma) confirmed by a clinician 4. Proficient in English (sufficient to complete assessments and engage with the therapy/software) 5. Willing to be randomised to either treatment group (Standard Care or Blended VR Care)