Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588270
Status:
RECRUITING
Last Update Posted:
None
First Post:
2022-11-15
Brief Title:
Effect of Virtual Reality-based Therapy on Negative Symptoms in People with Schizophrenia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Virtual Reality-based Therapy on Negative Symptoms in People with Schizophrenia Study Protocol for a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
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:
VR-SCHIZO
Brief Summary:
A randomised controlled double-blind clinical trial will be carried out to evaluate the effectiveness of a VR assisted treatment for negative symptoms in people with schizophrenia Patients with a standardised diagnosis of schizophrenia meeting the inclusion criteria will receive 12 weekly sessions of VR assisted therapy plus treatment as usual TAU A control group will be exposed to a neutral VR environment plus TAU The hypothesis is that patients who are treated with active VR assisted therapy will have less negative symptoms as rated by the PANSS-N scale compared to the control group
The protocol was approved by the hospital ethics committee of the Servicio de Salud Metropolitano Suroriente Patients sign an informed consent form from which they may withdraw at any point during the intervention
The protocol was approved by the hospital ethics committee of the Servicio de Salud Metropolitano Suroriente Patients sign an informed consent form from which they may withdraw at any point during the intervention
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