VR-based Avatar Therapy for Treatment of Auditory Hallucinations

Not Applicable

Recruiting

• Conditions: Hallucinations, Auditory; Schizophrenia Spectrum and Other Psychotic Disorders
• Interventions: Behavioral: AVATAR therapy

• Registration Number: NCT06505564
• Lead Sponsor: Semmelweis University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-02
• Study First Submitted QC: 2024-07-10
• Study First Posted: 2024-07-17
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-19
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AVATAR therapy	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

Primary Outcome Measures

Name	Time	Method
Change in symptom severity	Week 0, Week 12, Week 24	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.
Change in severity of auditory hallucinations	Week 0, Week 12, Week 24	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.
Change in beliefs about voices in schizophrenia spectrum disorder	Week 0, Week 12, Week 24	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.

Secondary Outcome Measures

Name	Time	Method
Change in comorbidity (depression)	Week 0, Week 12, Week 24	Calgary Depression Scale for Schizophrenia: Evaluates the severity of depressive symptoms in patients with schizophrenia. It is administered through a semi-structured interview, conducted by trained clinicians. The scale comprises 9 items, with each item being rated from 0 (absent) to 3 (severe). The total score range for the test is 0 to 27, where lower scores indicate reduced depressive symptoms and improved comorbidity management.
Change in comorbidity (anxiety)	Week 0, Week 12, Week 24	State-Trait Anxiety Inventory: A self-report questionnaire designed to assess anxiety levels in individuals. It distinguishes between two types of anxiety: State Anxiety: Refers to temporary feelings of anxiety that are situational and can fluctuate based on current circumstances.; Trait Anxiety: Refers to a stable characteristic of an individual, reflecting a general tendency to respond with anxiety across various situations.; The test consists of 40 items, with 20 items dedicated to measuring state anxiety and 20 items for trait anxiety. Respondents indicate how they feel on a scale from 1 (not at all) to 4 (very much so). Scores for each sub-scale can range from 20 to 80, with higher scores indicating greater levels of anxiety.
Change in subjective well-being	Week 0, Week 12, Week 24	World Health Organisation Well-being Index: A brief self-report measure designed to assess subjective well-being and overall quality of life. Comprising five items, the index evaluates key aspects of emotional well-being over the past two weeks, including mood, energy, and general happiness. Respondents rate each item on a scale from 0 (at no time) to 5 (all of the time), resulting in a total score ranging from 0 to 25. Higher scores indicate better well-being and psychological health.
Change in health-related quailty of life	Week 0, Week 12, Week 24	EuroQol 5-Dimension 5-Level Scale: A standardised instrument for measuring health-related quality of life. It consists of two main components: the descriptive system and the visual analog scale.; The descriptive system includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents rate their health status in each dimension on a scale from 1 (no problems) to 5 (extreme problems), resulting in a profile that can be converted into a single index value.; The visual analog scale allows individuals to rate their overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Change in emotion regulation	Week 0, Week 12, Week 24	Emotion Regulation Questionnaire: A self-report measure designed to assess individual differences in the habitual use of two emotion regulation strategies: cognitive reappraisal and expressive suppression. The questionnaire consists of 10 items, with respondents indicating their agreement on a scale from 1 (strongly disagree) to 7 (strongly agree). The possible total scores range from 10 to 70, with higher scores on cognitive reappraisal typically associated with better psychological outcomes, while higher scores on expressive suppression may be linked to various negative effects.
Change in self-efficacy	Week 0, Week 12, Week 24	General Self-Efficacy Scale: A self-report scale designed to assess perceived self-efficacy in coping with various stressors and challenges. The scale consists of 10 items that assess confidence in one's ability to handle different situations and overcome obstacles. Respondents rate each item on a scale from 1 (not at all true) to 4 (exactly true). Scores can range from 10-40, with higher scores indicate greater perceived self-efficacy.

Trial Locations

Locations (4)

Uniwersytet Medyczny w Łodzi; 🇵🇱 Łódź, Poland

Unitat de Recerca del Parc Sanitari Sant Joan de Déu; 🇪🇸 Barcelona, Spain

University of Barcelona; 🇪🇸 Barcelona, Spain

Semmelweis University; 🇭🇺 Budapest, Hungary