VR-based Avatar Therapy for Treatment of Auditory Hallucinations

ConditionsHallucinations, Auditory Schizophrenia Spectrum and Other Psychotic Disorders

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorSemmelweis University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

90 Participants

are divided into 1 treatment group

Group A: AVATAR therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

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.

Time frame

Week 0, Week 12, Week 24

Secondary outcomes

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.

Time frame

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.

Time frame

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).

Time frame

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.

Time frame

Week 0, Week 12, Week 24

Other outcomes

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.

Time frame

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.

Time frame

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.

Time frame

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.

Time frame

After every therapy session between Week 13 and Week 23