Virtual reality therapy for treating auditory hallucinations
VR-based Avatar Therapy for Treatment of Auditory Hallucinations in Patients With Schizophrenia 2023-SUD-3446
This study is testing a virtual reality therapy called AVATAR to see if it can help reduce the intensity and frequency of auditory hallucinations in people with schizophrenia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Semmelweis University Academic / other |
| Locations | 4 sites (Budapest and 3 other locations) |
| Trial ID | NCT06505564 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of AVATAR therapy, a virtual reality-based intervention designed to reduce the intensity and frequency of auditory hallucinations in patients with schizophrenia spectrum disorder. Over a 12-week period, participants will undergo seven individual therapy sessions lasting 50 minutes each, guided by a trained psychotherapist following a strict protocol. The study will enroll 30 patients from three clinical sites located in Hungary, Spain, and Poland, and will compare outcomes against a waiting list control group.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with schizophrenia spectrum disorder who experience auditory hallucinations and are stable on their medication.
Not a fit: Patients who may not benefit include those with severe visual impairments, significant cognitive disabilities, or those who are averse to virtual reality technology.
Why it matters
Potential benefit: If successful, this therapy could significantly improve the quality of life for patients experiencing persistent auditory hallucinations despite medication.
How similar studies have performed: While the use of virtual reality in therapeutic settings is gaining traction, this specific approach to AVATAR therapy for auditory hallucinations is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of schizophrenia spectrum disorder according to DSM-5, * Age 18 or older, * The fluent use of the spoken language at the site (Hungarian/Spanish/Polish), * Informed consent provided by the patient or their caregiver after being informed about the research procedure * Stable medication dosage for at least 4 weeks prior to recruitment, * Regular psychiatric follow-up, * Experience of auditory hallucinations for at least three months (PANSS hallucination score of at least 3 points), * Meeting the remission criteria described by Andreasen, except for the score related to auditory hallucinations Exclusion Criteria: * Inability to identify a single dominant voice that is the subject of the intervention, * Lack of cooperation, * Intellectual disability based on medical history, * Regular substance abuse * Central nervous system injury or neurological disease that affects cognitive performance, * Suicidal risk * Aversion to virtual reality, * Severe visual impairment
Where this trial is running
Budapest and 3 other locations
- Semmelweis University — Budapest, Hungary (Recruiting)
- Uniwersytet Medyczny w Łodzi — Lodz, Poland (Not_yet_recruiting)
- Unitat de Recerca del Parc Sanitari Sant Joan de Déu — Barcelona, Spain (Not_yet_recruiting)
- University of Barcelona — Barcelona, Spain (Active_not_recruiting)
Study contacts
- Study coordinator: Edit Vass, PhD
- Email: vass.edit@semmelweis.hu
- Phone: +36 30 360 9164
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.