VR-based Avatar Therapy for Treatment of Auditory Hallucinations

Last updated: July 17, 2024
Sponsor: Semmelweis University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Autism

Schizophrenia And Schizoaffective Disorders (Pediatric)

Schizophrenia And Schizoaffective Disorders

Treatment

AVATAR therapy

Clinical Study ID

NCT06505564
VR-AT-SCH 2023-SUD-3446
  • Ages > 18
  • All Genders

Study 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

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 informedabout 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 hallucinationscore of at least 3 points),

  • Meeting the remission criteria described by Andreasen, except for the score relatedto auditory hallucinations

Exclusion

Exclusion Criteria:

  • Inability to identify a single dominant voice that is the subject of theintervention,

  • Lack of cooperation,

  • Intellectual disability based on medical history,

  • Regular substance abuse

  • Central nervous system injury or neurological disease that affects cognitiveperformance,

  • Suicidal risk

  • Aversion to virtual reality,

  • Severe visual impairment

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: AVATAR therapy
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Semmelweis University

    Budapest,
    Hungary

    Active - Recruiting

  • Uniwersytet Medyczny w Łodzi

    Łódź,
    Poland

    Site Not Available

  • Unitat de Recerca del Parc Sanitari Sant Joan de Déu

    Barcelona,
    Spain

    Site Not Available

  • University of Barcelona

    Barcelona,
    Spain

    Site Not Available

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