VR-based Avatar Therapy for Treatment of Auditory Hallucinations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hallucinations, Auditory Schizophrenia Spectrum and Other Psychotic Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This study aims to evaluate the efficacy of AVATAR therapy in patients with schizophrenia spectrum disorder using a single-group pre-post design with a waiting list control period. Initially, all patients will undergo a 12-week waiting list control period without treatment. Following this phase, participants will receive AVATAR therapy consisting of 7 sessions over 12 weeks. Comprehensive assessments will be conducted before and at the end of the waiting list period, with post-therapy assessments following the intervention. Evaluations by caregivers and therapists will also be included to provide comprehensive insights into the therapy's effectiveness and overall impact.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

AVATAR therapy

Intervention Type BEHAVIORAL

In the initial phase of treatment, patients collaborate with therapists to visualize the source of their auditory hallucinations. Therapists adjust their voice to match the hallucinations, prompting patients to recall key statements for future sessions. Subsequent sessions involve dialogues with a computerized avatar. Using the altered voice, therapists interact in real-time through the avatar, engaging patients in role-playing. They alternate between the avatar and supportive therapist roles to empower patients with positive affirmations and discussions. Sessions last approximately 50 minutes, utilizing Oculus Rift VR headsets and noise-cancelling headphones to enhance immersion. HEKA VR software adjusts avatar proximity, and patients have the option to record dialogues for home use and sharing. Therapists receive bi-weekly supervision from HEKA VR-trained colleagues. Participants continue their regular medication prescribed by their psychiatrists alongside this experimental therapy

Interventions

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AVATAR therapy

In the initial phase of treatment, patients collaborate with therapists to visualize the source of their auditory hallucinations. Therapists adjust their voice to match the hallucinations, prompting patients to recall key statements for future sessions. Subsequent sessions involve dialogues with a computerized avatar. Using the altered voice, therapists interact in real-time through the avatar, engaging patients in role-playing. They alternate between the avatar and supportive therapist roles to empower patients with positive affirmations and discussions. Sessions last approximately 50 minutes, utilizing Oculus Rift VR headsets and noise-cancelling headphones to enhance immersion. HEKA VR software adjusts avatar proximity, and patients have the option to record dialogues for home use and sharing. Therapists receive bi-weekly supervision from HEKA VR-trained colleagues. Participants continue their regular medication prescribed by their psychiatrists alongside this experimental therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No