Using Virtual Reality and Neurofeedback to Treat Auditory Hallucinations in Schizophrenia
The Neuro-VR Study: A Pilot Study Investigating an Innovative Virtual Reality-based Intervention Employing Neurofeedback to Increase Tolerability and Therapy Efficacy in Psychosis
This study is testing a new treatment that combines virtual reality and brain feedback to see if it can help people with schizophrenia who experience auditory hallucinations feel better and improve their daily lives.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Mental Health Services in the Capital Region, Denmark Academic / other |
| Locations | 1 site (Copenhagen, Hellerup) |
| Trial ID | NCT06628323 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility and acceptability of a combined Virtual Reality (VR) and electroencephalogram (EEG)-based neurofeedback (VR-NF) intervention for treating auditory hallucinations in individuals with schizophrenia. Participants will be randomly assigned to receive either the VR-NF treatment or VR therapy alone over eight sessions. The study will assess the effectiveness of the VR-NF approach in reducing the severity of auditory hallucinations and improving daily functioning and quality of life. Assessments will be conducted at baseline and 12 weeks post-treatment to measure outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of schizophrenia spectrum disorder experiencing auditory verbal hallucinations.
Not a fit: Patients with organic brain diseases, intellectual disabilities, or those unable to tolerate the therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and effective treatment option for individuals suffering from auditory hallucinations associated with schizophrenia.
How similar studies have performed: While the combination of VR and neurofeedback is innovative, previous studies have shown promise in using VR for treating auditory hallucinations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ability to give informed consent 2. Age of 18-65 years 3. Diagnosis of schizophrenia spectrum disorder (ICD-10 codes: F20, F22-23; F25-29) 4. Symtoms of Auditory Verbal Hallucinations within at least the past 3 months (corresponding to SAPS score of 3 or more) 5. Identification of at least one dominant voice 6. No changes in antipsychotic medications four weeks prior to inclusion in the project 7. No planned changes in antipsychotic medication in the 12 weeks following inclusion in the project 8. A command of Danish or English sufficient to engage in therapy Exclusion Criteria: 1. Rejecting informed consent 2. A diagnosis of organic brain disease 3. Intellectual disability (IQ ˂ 70) 4. A primary diagnosis of substance dependence hindering engaging in therapy 5. Hear voices in a language the therapist does not speak 6. Inability to tolerate the therapy
Where this trial is running
Copenhagen, Hellerup
- Copenhagen Research Center for Mental Health - CORE — Copenhagen, Hellerup, Denmark (Recruiting)
Study contacts
- Principal investigator: Louise B. Glenthøj, DMSc, PhD — Copenhagen Research Center for Mental Health - CORE
- Study coordinator: Sara B. Soleim, MSc (Psych.)
- Email: sara.breivik.soleim@regionh.dk
- Phone: + 45 20131129
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.