VR-based Avatar Therapy for Treatment of Auditory Hallucinations
NCT Number: NCT06505564
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hallucinations, Auditory|Schizophrenia Spectrum and Other Psychotic Disorders
Interventions: BEHAVIORAL: AVATAR therapy
Sponsor: Semmelweis University
Collaborators: University of Barcelona|Parc Sanitari Sant Joan de Déu|Fundació Sant Joan de Déu|Uniwersytet Medyczny w Łodzi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2025-12-31
Locations: Semmelweis University, Budapest, Hungary|Uniwersytet Medyczny w Łodzi, Łódź, Poland|Unitat de Recerca del Parc Sanitari Sant Joan de Déu, Barcelona, Spain|University of Barcelona, Barcelona, Spain

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.

Primary Outcome Measures: 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 Outcome Measures: Change in comorbidity (depression), 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., Week 0, Week 12, Week 24|Change in comorbidity (anxiety), 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., Week 0, Week 12, Week 24|Change in health-related quailty of life, 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)., Week 0, Week 12, Week 24|Change in subjective well-being, 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., Week 0, Week 12, Week 24|Change in emotion regulation, 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., Week 0, Week 12, Week 24|Change in self-efficacy, 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., Week 0, Week 12, Week 24
Other Outcome Measures: Patient satisfaction, Patient Satisfaction Questionnaire: The questionnaire evaluates overall satisfaction with AVATAR therapy sessions by using open-ended questions and Likert scales. This questionnaire was created by the research team and adjusted specifically for this therapy., Week 24|Therapist opinion, Therapist Opinion Questionnaire: The questionnaire assesses therapists' subjective opinions on the effectiveness and feasibility of AVATAR therapy by using open-ended questions and Likert scales. This questionnaire was created by the research team and adjusted specifically for this therapy., Week 24|Caregiver opinion, Caregiver Opinion questionnaire: The questionnaire measures caregivers' perspectives on the impact of AVATAR therapy on patient well-being and daily functioning by using a questionnaire that includes open-ended questions and Likert scales. his questionnaire was created by the research team and adjusted specifically for this therapy., Week 24|Side effects, Simulator sickness questionnaire: A self-report tool used to assess symptoms of simulator sickness, which can occur during virtual reality. The questionnaire consists of 16 items that measure various symptoms associated with simulator sickness, including nausea, disorientation, and eye strain. Respondents rate the severity of each symptom on a scale from 0 (none) to 3 (severe). The total score ranges from 0-48, with higher scores indicating greater severity of simulator sickness., After every therapy session between Week 13 and Week 23|Cost-effectiveness analysis of the intervention, Conduct a thorough cost-effectiveness analysis within health economics, assessing the economic impact of the healthcare intervention under investigation through meticulous collection and analysis of healthcare utilization data, intervention-related costs, and health outcomes data. This will be achieved using a detailed demographic questionnaire, which includes information on disease duration (time since diagnosis), illness progression (such as frequency and duration of hospital stays), direct and indirect costs of care (such as medication costs, productivity loss, travel expenses, and caregiver burden), and patient living conditions (covering socio-economic status, employment, and living arrangements). The health economic evaluation will involve repeated administration of this questionnaire, ensuring adherence to established best practices and ethical standards, Week 0, Week 12, Week 24