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. DISCUSSION: This 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.