Neuro-VR: Augmenting a Virtual Reality-based Therapy With Biofeedback for Auditory Hallucinations (NCT06628323) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Neuro-VR: Augmenting a Virtual Reality-based Therapy With Biofeedback for Auditory Hallucinations
Denmark30 participantsStarted 2024-11-12
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility and acceptability as assessed by recruitment rate
Timeframe: Recruitment rate is monitored throughout the study period (1 year)
2
Feasibility and acceptability to the VR-NF intervention as assessed by retention rate
Timeframe: Retention rates are monitored throughout the study period (1 year)
3
Feasibility and acceptability to the VR-NF intervention as assessed by level of satisfaction in the experimental group
Timeframe: At 12 weeks follow up
Trial details
NCT IDNCT06628323
SponsorUniversity Hospital Bispebjerg and Frederiksberg