NCT06628323Completed
Neuro-VR: Augmenting a Virtual Reality-based Therapy With Biofeedback for Auditory Hallucinations
The Neuro-VR Study: A Pilot Study Investigating an Innovative Virtual Reality-based Intervention Employing Biofeedback to Increase Tolerability and Therapy Efficacy in Psychosis
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 19 Aug 2024
- Start date
- 12 Nov 2024
- Primary completion date
- 22 Apr 2026
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Diseases
- Schizophrenia
- NCT number
- NCT06628323
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 12 Nov 2024 to the primary completion date, 22 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A primary diagnosis of substance dependence hindering engaging in therapy
- Inability to tolerate the therapy
Other illness
- A diagnosis of organic brain disease
Other
- Rejecting informed consent
- Intellectual disability (IQ ˂ 70)
- Hear voices in a language the therapist does not speak
Who the study is looking for
- Ability to give informed consent
- Age of 18-65 years
- Diagnosis of schizophrenia spectrum disorder (ICD-10 codes: F20, F22-23; F25-29)
- Symtoms of Auditory Verbal Hallucinations within at least the past 3 months (corresponding to SAPS score of 3 or more)
- Identification of at least one dominant voice
- No changes in antipsychotic medications four weeks prior to inclusion in the project
- No planned changes in antipsychotic medication in the 12 weeks following inclusion in the project
- A command of Danish or English sufficient to engage in therapy
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Copenhagen Research Center for Mental Health (CORE) Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.