VR-based Avatar Therapy for Treatment of Auditory Hallucinations in Patients With Schizophrenia 2023-SUD-3446

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Hungary
Semmelweis University
RECRUITING
Budapest
Poland
Uniwersytet Medyczny w Łodzi
NOT_YET_RECRUITING
Lodz
Spain
Unitat de Recerca del Parc Sanitari Sant Joan de Déu
NOT_YET_RECRUITING
Barcelona
University of Barcelona
ACTIVE_NOT_RECRUITING
Barcelona
Contact Information
Primary
Edit Vass, PhD
vass.edit@semmelweis.hu
+36 30 360 9164
Backup
Gábor Csukly, PhD
csugab@yahoo.com
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 90
Treatments
Experimental: AVATAR therapy
All participants will initially undergo a 12-week waiting period (control period) starting from the initial screening at week 0. Baseline assessments will be conducted at week 12. Subsequently, participants will receive AVATAR therapy for 12 weeks. Post-therapy assessments will be conducted at week 24. Caregivers and therapists will also provide evaluations to gather additional insights into the therapy's impact
Related Therapeutic Areas
Sponsors
Leads: Semmelweis University
Collaborators: University of Barcelona, Parc Sanitari Sant Joan de Déu, Uniwersytet Medyczny w Łodzi, Fundació Sant Joan de Déu

This content was sourced from clinicaltrials.gov