Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06505564

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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