Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2025-12-30 @ 2:13 PM
Study NCT ID:
NCT05704868
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2022-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UniVRse: VR-CBT for Students With Social Anxiety
Sponsor:
University of Surrey
Organization:
Study Overview
Official Title:
UniVRse: Pilot Randomised Controlled Trial of Virtual Reality Cognitive Behaviour Therapy (VR-CBT) for Students With Social Anxiety
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UniVRse
Brief Summary:
The goal of this pilot randomised controlled trial is to evaluate the effectiveness of the UniVRse VR-CBT programme in students with social anxiety. The aims of this trial are:
1. To determine whether a full trial is justified;
2. To establish the effect size on the co-primary outcomes for a sample size calculation for a definitive trial;
3. To address questions concerning study recruitment, retention, and acceptability.
Participants will complete a baseline assessment (T0) and then be randomly allocated to receive either UniVRse VR-CBT or join the wait-list control group. UniVRse VR-CBT uses graded exposure techniques delivered using VR to help students feel more confident in university-based situations. Data will be collected post-intervention (T1) along with exit interviews to assess participant experience.
1. To determine whether a full trial is justified;
2. To establish the effect size on the co-primary outcomes for a sample size calculation for a definitive trial;
3. To address questions concerning study recruitment, retention, and acceptability.
Participants will complete a baseline assessment (T0) and then be randomly allocated to receive either UniVRse VR-CBT or join the wait-list control group. UniVRse VR-CBT uses graded exposure techniques delivered using VR to help students feel more confident in university-based situations. Data will be collected post-intervention (T1) along with exit interviews to assess participant experience.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: