NCT06505564 VR-based Avatar Therapy for Treatment of Auditory Hallucinations
| NCT ID | NCT06505564 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Semmelweis University |
| Condition | Hallucinations, Auditory |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2024-03-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary aim of this study is to evaluate the safety and efficacy of AVATAR therapy, developed to address residual auditory hallucinations persisting despite medication in schizophrenia spectrum disorder. The intervention aims to reduce the intensity and frequency of these symptoms, as well as alleviate associated depressive and anxiety symptoms, using a virtual reality (VR)-assisted intervention developed for this purpose by the Danish company HEKA VR. The study will be a pre-post non-invasive, waiting list-controlled study, enrolling 30 patients from three clinical sites (Hungary, Spain, Poland). The study centers around administering therapy based on VR over a 12-week period, comprising a total of 7 sessions. These sessions are conducted individually and last 50 minutes each. The psychotherapist leading the sessions adheres to a strict protocol defined by the method's developers. During the intervention, VR technology is used to simulate the source of distressing auditory hallucinations. The therapist facilitates coping with these experiences externalized in this way through simulated conversations, supporting the development of more adaptive responses. Patients undergo a comprehensive cross-sectional evaluation of their condition before and after the intervention, including assessments of symptom severity, quality of life, and their experience with the method. The intervention is conducted with constant monitoring for possible adverse effects.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06505564 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hallucinations, Auditory. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06505564 currently recruiting?
Yes, NCT06505564 is actively recruiting participants. Contact the research team at vass.edit@semmelweis.hu for enrollment information.
Where is the NCT06505564 trial being conducted?
This trial is being conducted at Budapest, Hungary, Lodz, Poland, Barcelona, Spain, Barcelona, Spain.
Who is sponsoring the NCT06505564 clinical trial?
NCT06505564 is sponsored by Semmelweis University. The trial plans to enroll 90 participants.