VR-based Avatar Therapy for Treatment of Auditory Hallucinations

NCT06505564 | Recruiting DMC

• 1 other identifier: VR-AT-SCH 2023-SUD-3446
• Study Type: interventional
• Target: 90
• Locations: 3 countries
• Sites: 4

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.

Conditions

Hallucinations, Auditory; Schizophrenia Spectrum and Other Psychotic Disorders

Keywords

Virtual reality; AVATAR therapy; Auditory verbal hallucation; Schizophrenia spectrum disorder

Outcome Measures

Primary Outcomes (3)

• Change in symptom severity

  Positive and Negative Syndrome Scale: Assesses overall symptom severity in schizophrenia spectrum disorders, including positive symptoms (e.g., hallucinations, delusions), negative symptoms (e.g., affective flattening, social withdrawal), and general psychopathology (e.g., anxiety, depression).The scale is administered through a semi-structured interview by trained clinicians. The minimum possible score for positive and negative symptoms is 7 points, and the maximum possible score is 49 points. For general symptomatology, the possible minimum score is 16 points, and the maximum score is 112 points. The overall score can range from 30-210. Higher scores indicate greater symptom severity.

  Week 0, Week 12, Week 24

• Change in severity of auditory hallucinations

  Psychotic Symptom Rating Scales: Evaluates the severity of auditory hallucinations and associated delusions, including frequency, duration, loudness, and disruption. The scale is administered through a semi-structured interview by trained clinicians. The scale comprises 17 items of the mentioned specific dimensions of hallucinations and delusions, with each item being rated from 0 (absent) to 4 (severe). The total score range for the test is 0 to 68, where lower scores indicate reduced severity of hallucinatory experiences.

  Week 0, Week 12, Week 24

• Change in beliefs about voices in schizophrenia spectrum disorder

  Beliefs About Voices Questionnaire-Revised: A self-report questionnaire designed to assess individuals' beliefs about auditory hallucinations (e.g.: how important the voices are to the individual, perceived control, emotional reactions elicited by the voices. The scale comprises 35 items, with each item being rated from 0 to 3. The total score range for the test is 0-105, where lower scores indicate reduced distress and improved coping with hallucinatory experiences.

  Week 0, Week 12, Week 24

Secondary Outcomes (6)

• Change in comorbidity (depression)

  Week 0, Week 12, Week 24

• Change in comorbidity (anxiety)

  Week 0, Week 12, Week 24

• Change in health-related quailty of life

  Week 0, Week 12, Week 24

• Change in subjective well-being

  Week 0, Week 12, Week 24

• Change in emotion regulation

  Week 0, Week 12, Week 24

Other Outcomes (5)

• Patient satisfaction

  Week 24

• Therapist opinion

  Week 24

• Caregiver opinion

  Week 24

Study Arms (1)

AVATAR therapy

EXPERIMENTAL

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

Behavioral: AVATAR therapy

Interventions

AVATAR therapy 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

AVATAR therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Semmelweis University: lead
• University of Barcelona: collaborator
• Parc Sanitari Sant Joan de Déu: collaborator
• Fundació Sant Joan de Déu: collaborator
• Uniwersytet Medyczny w Łodzi: collaborator

Study Sites (4)

Semmelweis University

Budapest, Hungary

RECRUITING

Uniwersytet Medyczny w Łodzi

Lodz, Poland

NOT YET RECRUITING

Unitat de Recerca del Parc Sanitari Sant Joan de Déu

Barcelona, Spain

NOT YET RECRUITING

University of Barcelona

Barcelona, Spain

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Hallucinations; Schizophrenia Spectrum and Other Psychotic Disorders

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Edit Vass, PhD

CONTACT

+36 30 360 9164; vass.edit@semmelweis.hu

Gábor Csukly, PhD

CONTACT

csugab@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 17, 2024
• Study Start: March 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1); ES (2); PL (1)