# 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

## TL;DR

This pilot study tests if adding biofeedback to virtual reality therapy helps manage hallucinations in schizophrenia by improving personalization and emotion regulation.

## Contribution

The study introduces a novel approach combining VR-assisted therapy with real-time biofeedback to enhance treatment for auditory verbal hallucinations.

## Key findings

- Assesses feasibility and acceptability of integrating biofeedback into VR therapy for AVH.
- Evaluates how physiological markers can guide and improve VR-based interventions for schizophrenia patients.
- Provides preliminary evidence on the effectiveness of combined VR and biofeedback therapy.

## Abstract

Auditory 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.

Neuro-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.

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.

ClinicalTrials.gov NCT06628323.