VR-based Avatar Therapy for Treatment of Auditory Hallucinations

Semmelweis University

Status: Enrolling

Conditions: Schizophrenia Spectrum and Other Psychotic Disorders; Hallucinations, Auditory

Treatments: Behavioral: AVATAR therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06505564

VR-AT-SCH 2023-SUD-3446

Details and patient eligibility

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

AVATAR therapy

Experimental group

Description:

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

Treatment:

Behavioral: AVATAR therapy