Face Your Fears: Virtual reality-based cognitive behavioral therapy (VR-CBT) versus standard CBT for paranoia in patients with schizophrenia spectrum disorders: Results of a randomized clinical trial

Paranoia is a distressing and prevalent symptom in schizophrenia spectrum disorders (SSD). This assessor-masked, randomized parallel group superiority trial investigated the efficacy of virtual reality-based cognitive behavioral therapy (VR-CBT) compared to standard CBT targeting paranoia. A total of 259 participants with SSD and paranoia were randomized to receive 10 sessions of VR-CBT or standard CBT, excluding five who later withdrew informed consent. Intention-to-treat analyses included 254 participants (VR-CBT: n = 126, standard CBT: n = 128). Outcomes were assessed at baseline, treatment cessation (3 months) and follow-up (9 months). The primary outcome was the Green Paranoid Thought Scale (GPTS) subscale Ideas of Persecution , measured at treatment cessation. Linear mixed-model analyses revealed no statistically significant difference between the groups at endpoint (adjusted mean difference 1.12, 95% CI: -1.75 to 3.99 Cohen’s d=0.10; p=0.44). Both groups demonstrated large with-in group improvements on the primary outcome (VR-CBT: Cohen’s d=0.88; standard CBT: Cohen’s d=0.87). No deaths or violent incidents involving law enforcement occurred during the study. These findings do not support the superiority of VR-CBT over standard CBT; rather, both interventions significantly reduced paranoia and represent promising treatment options for SSD-related paranoia. ClinicalTrials.gov identifier NCT04902066.