ICU-specific virtual reality for mental health after critical illness: an international three-arm randomized clinical trial.

Survivors of critical illness frequently experience symptoms of post-intensive care syndrome (PICS), including post-traumatic stress disorder (PTSD), anxiety, and depression, with downstream impact on health-related quality of life (HRQoL). We evaluated whether an intensive care unit-specific virtual reality (ICU-VR) video improves mental health outcomes and whether timing (early vs. late) matters. We conducted an international, three-arm, multicentre randomized clinical trial across eleven hospitals. Adults (≥ 18 years) with ICU stay ≥ 72 h and mechanical ventilation ≥ 24 h were randomized 1:1:1 to (1) standard care, (2) early ICU-VR (within 7-15 days post-ICU), or (3) late ICU-VR (≈ 3 months, during aftercare). The primary endpoint was PTSD symptom severity at six months (T3) measured by the Impact of Event Scale-Revised (range 0-88). Secondary endpoints included anxiety/depression severity and prevalence, and HRQoL. We randomized 344 participants (median age 61 years; 62% male); follow-up among survivors at six months (T3) was 80%. At six months, PTSD symptom severity did not differ between early ICU-VR and control (β = 0.32; 95% CI -3.38 to 4.02; p = 0.87) nor late ICU-VR and control (-0.82; 95% CI -4.62 to 2.97; p = 0.67). No between-group differences were observed for anxiety, depression, or HRQoL (all adjusted p > 0.05). Patients rated ICU-VR highly for improving understanding of the ICU experience and overall satisfaction (median 8/10). In this multicentre randomized clinical trial, a single ICU-VR video did not improve PTSD, anxiety, depression, or HRQoL at six months versus standard care. Findings should not be generalized to multi-session, therapist-guided, or personalized VR interventions. Future trials should target high-risk patients, make multi-session mandatory, and personalize ICU-VR. This study was prospectively registered Netherlands: Trial Register/International Clinical Trials Registry Platform, NL9812, October 21, 2021.