Hallucinations, AuditoryNCT06505564
VR-based Avatar Therapy for Treatment of Auditory Hallucinations
A study testing AVATAR therapy in people with Hallucinations, Auditory and Schizophrenia Spectrum and Other Psychotic Disorders, run by Semmelweis University at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallucinations, Auditory, Schizophrenia Spectrum and Other Psychotic Disorders
- What is being tested?
- AVATAR therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 1 Mar 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 3 countries.
Gábor Csukly, PhD contact
4 sites in 3 countries
Spain2 sites, 1 recruiting
- Not yet recruiting
Unitat de Recerca del Parc Sanitari Sant Joan de Déu
Barcelona
Suzana Ochoa, susana.ochoa@sjd.es
Luciana Díaz-Cutraro
- Active, not recruiting
University of Barcelona
Barcelona
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University
Budapest
Edit Vass, vass.edit@semmelweis.hu
Gábor Csukly
Poland1 site, 1 recruiting
- Not yet recruiting
Uniwersytet Medyczny w Łodzi
Lodz
Jakub Kazmierski, jakub.kazmierski@umed.lodz.pl
Jakub Kazmierski
About this study
Official title: VR-based Avatar Therapy for Treatment of Auditory Hallucinations in Patients With Schizophrenia 2023-SUD-3446
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.
Read more
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.
- Being tested
- AVATAR therapy
- Keywords
- Virtual reality, AVATAR therapy, Auditory verbal hallucation, Schizophrenia spectrum disorder
- Medical subject headings
- Hallucinations, Schizophrenia Spectrum and Other Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVATAR therapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: AVATAR therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Week 0, Week 12, Week 24
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 0, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallucinations, AuditoryStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Barcelona, Parc Sanitari Sant Joan de Déu, Fundació Sant Joan de Déu, Uniwersytet Medyczny w Łodzi
- Responsible party
- Principal investigator, Gábor Csukly, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505564
- Sponsor's protocol ID
- VR-AT-SCH 2023-SUD-3446
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VR-based Avatar Therapy for Treatment of Auditory Hallucinations in Patients With Schizophrenia 2023-SUD-3446
- ClinicalTrials.gov ID
- NCT06505564
- Acronym / sponsor ID
- VR-AT-SCH 2023-SUD-3446
- Keywords
- Virtual reality, AVATAR therapy, Auditory verbal hallucation, Schizophrenia spectrum disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Collaborators
- University of Barcelona, Parc Sanitari Sant Joan de Déu, Fundació Sant Joan de Déu, Uniwersytet Medyczny w Łodzi
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| AVATAR therapy | Experimental | Behavioral: AVATAR therapyAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVATAR therapyIn 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 | Behavioural | AVATAR therapy |
Primary outcome
Change in symptom severity
Time frame: 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
Time frame: 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
Time frame: 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.
6 secondary outcomes
Change in comorbidity (depression)
Time frame: Week 0, Week 12, Week 24
Change in comorbidity (anxiety)
Time frame: Week 0, Week 12, Week 24
Change in health-related quailty of life
Time frame: Week 0, Week 12, Week 24
Change in subjective well-being
Time frame: Week 0, Week 12, Week 24
Change in emotion regulation
Time frame: Week 0, Week 12, Week 24
Change in self-efficacy
Time frame: Week 0, Week 12, Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gábor Csukly, PhD contact
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVATAR therapy in people with Hallucinations, Auditory and Schizophrenia Spectrum and Other Psychotic Disorders, run by Semmelweis University at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, Hungary, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edit Vass, PhD (+36 30 360 9164, vass.edit@semmelweis.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptom severity (time frame: Week 0, Week 12, Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.