Clinical trial NCT06505564: VR-based Avatar Therapy for Treatment of Auditory Hallucinations
Official title: VR-based Avatar Therapy for Treatment of Auditory Hallucinations in Patients With Schizophrenia 2023-SUD-3446
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hallucinations, Auditory
Schizophrenia Spectrum and Other Psychotic Disorders
Keywords: Virtual reality
AVATAR therapy
Auditory verbal hallucation
Schizophrenia spectrum disorder
Lead sponsor: Semmelweis University
Sponsor class: OTHER
Collaborators: name: University of Barcelona
name: Parc Sanitari Sant Joan de Déu
name: Fundació Sant Joan de Déu
name: Uniwersytet Medyczny w Łodzi
First posted: 2024-07-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

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 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 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

Primary outcomes:
measure: Change in symptom severity
timeFrame: Week 0, Week 12, Week 24
measure: Change in severity of auditory hallucinations
timeFrame: Week 0, Week 12, Week 24
measure: Change in beliefs about voices in schizophrenia spectrum disorder
timeFrame: Week 0, Week 12, Week 24
Secondary outcomes:
measure: Change in comorbidity (depression)
timeFrame: Week 0, Week 12, Week 24
measure: Change in comorbidity (anxiety)
timeFrame: Week 0, Week 12, Week 24
measure: Change in health-related quailty of life
timeFrame: Week 0, Week 12, Week 24
measure: Change in subjective well-being
timeFrame: Week 0, Week 12, Week 24
measure: Change in emotion regulation
timeFrame: Week 0, Week 12, Week 24
measure: Change in self-efficacy
timeFrame: Week 0, Week 12, Week 24
Other outcomes:
measure: Patient satisfaction
timeFrame: Week 24
measure: Therapist opinion
timeFrame: Week 24
measure: Caregiver opinion
timeFrame: Week 24
measure: Side effects
timeFrame: After every therapy session between Week 13 and Week 23
measure: Cost-effectiveness analysis of the intervention
timeFrame: Week 0, Week 12, Week 24
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University
city: Łódź
country: Poland
facility: Uniwersytet Medyczny w Łodzi
city: Barcelona
country: Spain
facility: Unitat de Recerca del Parc Sanitari Sant Joan de Déu
city: Barcelona
country: Spain
facility: University of Barcelona
Study officials:
References: