Study protocol for a randomized clinical pilot trial investigating feasibility and efficacy of augmenting a virtual reality-assisted intervention targeting auditory verbal hallucinations with biofeedback: the Neuro-VR study

IntroductionAuditory Verbal Hallucinations (AVH) are among the most frequent and severe symptoms in schizophrenia and related psychotic disorders. Virtual Reality (VR)-assisted interventions have emerged, demonstrating promising potential in reducing AVH severity. This treatment approach may be challenged with regards to feasibility, particularly when therapeutically managing the anxiety-related reactions associated with AVH. This pilot study evaluates the feasibility and acceptability of augmenting VR-assisted therapy with real-time biofeedback to address these challenges. The integration of biofeedback enables continuous adaptation of therapy based on physiological responses while allowing participants to train self-regulation of these parameters. MethodsNeuro-VR is a randomized clinical pilot trial utilizing a mixed-methods design. Thirty participants with schizophrenia spectrum disorders and AVH will be randomized to either eight sessions of VR-assisted therapy or eight sessions of VR-assisted therapy augmented with real-time biofeedback. Assessments will be conducted at baseline and post-treatment. Outcome measures include both clinical metrics, electroencephalogram recordings, and qualitative interviews to evaluate feasibility, acceptability, and potential treatment effects of the combined approach. DiscussionThis study will explore whether integrating biofeedback into VR-assisted therapy enhances personalization, supports emotion regulation, and improves tolerability. The findings will provide preliminary evidence on the utility of physiological markers to guide VR-based interventions for AVH and inform the development of individualized, effective treatments for patients with schizophrenia. Trial registrationClinicalTrials.gov, NCT06628323 (https://clinicaltrials.gov/study/NCT06628323). Registered August 19, 2024.