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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Feasibility and acceptability as assessed by recruitment rate — Recruitment rate is monitored throughout the study period (1 year) Percentage of target sample (30 participants) recruited after 12 months from study start.
Feasibility and acceptability to the VR-NF intervention as assessed by retention rate — Retention rates are monitored throughout the study period (1 year) Percentage of included participants in the experimental group who retent to treatment at cessation of therapy (8 sessions).
Feasibility and acceptability to the VR-NF intervention as assessed by level of satisfaction in the experimental group — At 12 weeks follow up Percentage of participants in the experimental group reporting a satisfaction rating of more than 7 on a Likert scale ranging from 1-10 with higher scoring indicating a higher level of satisfaction with therapy.
Trial sites (1)
Facility
City
Region
Status
Copenhagen Research Center for Mental Health - CORE
Copenhagen
Hellerup
More University Hospital Bispebjerg and Frederiksberg trials in Denmark
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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