Status:

RECRUITING

VR-based Avatar Therapy for Treatment of Auditory Hallucinations

Lead Sponsor:

Semmelweis University

Collaborating Sponsors:

University of Barcelona

Parc Sanitari Sant Joan de Déu

Conditions:

Hallucinations, Auditory

Schizophrenia Spectrum and Other Psychotic Disorders

Eligibility:

All Genders

18+ years

Phase:

NA

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 di...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2025

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT06505564

Start Date

March 1 2024

End Date

December 31 2025

Last Update

July 19 2024

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Semmelweis University

Budapest, Hungary

2

Uniwersytet Medyczny w Łodzi

Lodz, Poland

3

Unitat de Recerca del Parc Sanitari Sant Joan de Déu

Barcelona, Spain

4

University of Barcelona

Barcelona, Spain