Actively Recruiting
VR-based Avatar Therapy for Treatment of Auditory Hallucinations
Led by Semmelweis University · Updated on 2024-07-19
90
Participants Needed
4
Research Sites
95 weeks
Total Duration
On this page
Sponsors
S
Semmelweis University
Lead Sponsor
U
University of Barcelona
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
VR-based Avatar Therapy for Treatment of Auditory Hallucinations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of schizophrenia spectrum disorder according to DSM-5
- Age 18 or older
- Fluent use of the spoken language at the site (Hungarian/Spanish/Polish)
- Informed consent provided by the patient or caregiver after learning about the study
- Stable medication dosage for at least 4 weeks before joining
- Regular psychiatric follow-up
- Experience of auditory hallucinations for at least 3 months with a PANSS hallucination score of at least 3 points
- Meeting remission criteria by Andreasen except for auditory hallucination score
You will not qualify if you...
- Unable to identify a single dominant voice for the therapy
- Lack of cooperation
- Intellectual disability based on medical history
- Regular substance abuse
- Central nervous system injury or neurological disease affecting cognition
- Suicidal risk
- Aversion to virtual reality
- Severe visual impairment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Semmelweis University
Budapest, Hungary
Actively Recruiting
2
Uniwersytet Medyczny w Łodzi
Lodz, Poland
Not Yet Recruiting
3
Unitat de Recerca del Parc Sanitari Sant Joan de Déu
Barcelona, Spain
Not Yet Recruiting
4
University of Barcelona
Barcelona, Spain
Active, Not Recruiting
Research Team
E
Edit Vass, PhD
CONTACT
G
Gábor Csukly, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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