Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505564
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-02
Brief Title:
VR-based Avatar Therapy for Treatment of Auditory Hallucinations
Sponsor:
None
Organization:
None
Study Overview
Official Title:
VR-based Avatar Therapy for Treatment of Auditory Hallucinations in Patients With Schizophrenia 2023-SUD-3446
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 methods 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
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 methods 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None