Neuro-VR: Augmenting a Virtual Reality-based Therapy With Biofeedback for Auditory Hallucinations

The primary goal of this pilot study is to examine the feasibility and acceptability of augmenting a Virtual Reality-based intervention for treating auditory hallucinations in schizophrenia with electroencephalogram (EEG)-based neurofeedback. The main questions it aims to answer are: 1. Is Virtual Reality -based therapy supplemented with EEG-based neurofeedback (VR-NF) a feasible and acceptable treatment for auditory hallucinations? 2. Will VR-NF show indications of being more effective than Virtual Reality-based therapy alone in reducing the severity of auditory hallucinations, improving daily functioning, and enhancing quality of life? Researchers will compare VR-NF to Virtual Reality-based therapy alone to evaluate therapy effectiveness. Participants will be allocated to receive 8 sessions of either VR-NF or Virtual Reality-based therapy alone. All participants will undergo a thorough assessment at baseline, and at 12 weeks post-baseline.

NCT Number	NCT06628323
Lead Sponsor	University Hospital Bispebjerg and Frederiksberg
Conditions	Auditory Hallucinations, Schizophrenia
Enrollment	30 participants
Start Date	2024-11-12
Primary Completion	2026-04-22 (estimated)
Study Completion	2026-05 (estimated)
Updated on ClinicalTrials.gov	2026-05-06