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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04099940
Other study ID # VRAT- ATP
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date December 31, 2025

Study information

Verified date September 2023
Source Psychiatric University Hospital, Zurich
Contact Stephan T. Egger, MD
Phone +41523049340
Email stephan.egger@puk.zh.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2025
Est. primary completion date May 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Virtual Reality Avatar Therapy (VRAT)
The Virtual Reality Avatar Therapy (VRAT) is a Cognitive Behavioral Intervention, delivered through Virtual Reality.
Assertiveness Training Program (ATP)
The Assertiveness Training Program (ATP) is a Cognitive Behavioral Intervention, delivered as group therapy.

Locations

Country Name City State
Switzerland Psychiatrische Universitätsklinik Zürich Zürich

Sponsors (1)

Lead Sponsor Collaborator
Psychiatric University Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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;: — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Psychopathological Assessment Symptom Questionnaire Change: Baseline, 3, 6 weeks, 6 and 12 months]
Secondary Psychotic Symptoms Symptom Questionnaire Change: Baseline, 3, 6 weeks, 6 and 12 months]
Secondary Insecurity- Self-confidence Symptom Questionnaire Change: Baseline, 3, 6 weeks, 6 and 12 months]
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