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 range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. Rejecting informed consent
✕. A diagnosis of organic brain disease

What they're measuring

Feasibility and acceptability as assessed by recruitment rate

Timeframe: Recruitment rate is monitored throughout the study period (1 year)

Feasibility and acceptability to the VR-NF intervention as assessed by retention rate

Timeframe: Retention rates are monitored throughout the study period (1 year)

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-22

View on ClinicalTrials.gov More Auditory Hallucinations trials