- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04099940
Virtual Reality Avatar Therapy for People Hearing Voices
September 26, 2023 updated by: Stephan T. Egger, Psychiatric University Hospital, Zurich
Hearing voices is probably the worst form of acoustic hallucinations; which can be experienced as severely disturbing and is influenced by diverse factors including the ability of the individual to influence and control the hallucinatory experience itself.
In recent years virtual reality has become a treatment option.
In the so-called AVATAR Therapy, patients with schizophrenia and acoustic hallucinations design a visual and auditory recreation (avatar) of the entity to which they attribute their hallucinations.
Working with a therapist over the course of several sessions, participants change the avatar from controlling to benevolent.
Avatar Therapy involves similar processes to learning and cognitive restructuring, comparable to other psychotherapeutic interventions.
The investigators plan to conduct an interventional study using a cross-over design, to compare the feasibility and efficacy of virtual reality avatar therapy for patients with acoustic hallucinations (independent of psychiatric diagnosis) with a cognitive behavioural group therapy aimed to improve social competence.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stephan T. Egger, MD
- Phone Number: +41523049340
- Email: stephan.egger@puk.zh.ch
Study Locations
-
-
-
Zürich, Switzerland, 8032
- Recruiting
- Psychiatrische Universitätsklinik Zürich
-
Contact:
- Stephan T Egger, MD
- Phone Number: +4152304940
- Email: stephan.egger@puk.zh.ch
-
Contact:
- Godehard Weniger, MD
- Phone Number: +41523049341
- Email: godehard.weniger@puk.zh.ch
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Consistent acoustic hallucinations, with the presence of voices for at least two months.
- Participants are competent to give informed consent, as determined by the referring physician or psychiatrist.
- German language proficiency as a native speaker or level B1 Common European Framework of Reference for Languages (CEFRL)
Exclusion Criteria:
- Current neurological disorder.
- Current substance use or withdrawal.
- Concomitant group psychotherapeutic intervention.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Virtual Reality Avatar Therapy (VRAT)
In the VRAT, patients with schizophrenia and acoustic hallucinations design a visual and auditory recreation (avatar) of the entity to which they attribute their hallucinations.
Working with a therapist over the course of several sessions, participants change the avatar from controlling to benevolent.
|
The Virtual Reality Avatar Therapy (VRAT) is a Cognitive Behavioral Intervention, delivered through Virtual Reality.
The Assertiveness Training Program (ATP) is a Cognitive Behavioral Intervention, delivered as group therapy.
|
Active Comparator: Assertiveness Training Program (ATP)
The ATP is a transdiagnostic cognitive behavioural treatment programme, which aims to increase self-confidence and social competence in patients with a psychiatric disorder.
|
The Virtual Reality Avatar Therapy (VRAT) is a Cognitive Behavioral Intervention, delivered through Virtual Reality.
The Assertiveness Training Program (ATP) is a Cognitive Behavioral Intervention, delivered as group therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychopathological Assessment
Time Frame: Change: Baseline, 3, 6 weeks, 6 and 12 months]
|
Symptom Questionnaire
|
Change: Baseline, 3, 6 weeks, 6 and 12 months]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychotic Symptoms
Time Frame: Change: Baseline, 3, 6 weeks, 6 and 12 months]
|
Symptom Questionnaire
|
Change: Baseline, 3, 6 weeks, 6 and 12 months]
|
Insecurity- Self-confidence
Time Frame: Change: Baseline, 3, 6 weeks, 6 and 12 months]
|
Symptom Questionnaire
|
Change: Baseline, 3, 6 weeks, 6 and 12 months]
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Craig TK, Rus-Calafell M, Ward T, Leff JP, Huckvale M, Howarth E, Emsley R, Garety PA. AVATAR therapy for auditory verbal hallucinations in people with psychosis: a single-blind, randomised controlled trial. Lancet Psychiatry. 2018 Jan;5(1):31-40. doi: 10.1016/S2215-0366(17)30427-3. Epub 2017 Nov 23. Erratum In: Lancet Psychiatry. 2017 Nov 29;:
- Brander M, Egger ST, Hurlimann N, Seifritz E, Sumner RW, Vetter S, Magnenat S. Virtual Reality Human-Human Interface to Deliver Psychotherapy to People Experiencing Auditory Verbal Hallucinations: Development and Usability Study. JMIR Serious Games. 2021 Jun 1;9(2):e26820. doi: 10.2196/26820.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2021
Primary Completion (Estimated)
May 30, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
September 18, 2019
First Submitted That Met QC Criteria
September 19, 2019
First Posted (Actual)
September 23, 2019
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 26, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VRAT- ATP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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