Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04868201
Status:
UNKNOWN
Last Update Posted:
2021-04-30
First Post:
2021-04-25
Brief Title:
A Self-guided App-Based Virtual Reality Cognitive Behavior Therapy for Anxiety Disorder in Children
Sponsor:
Universidade Federal do Rio de Janeiro
Organization:
Universidade Federal do Rio de Janeiro
Study Overview
Official Title:
A Self-guided App-Based Virtual Reality Cognitive Behavior Therapy for Anxiety Disorder in Children
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
To examine the efficacy of a fully self-guided app-based virtual reality cognitive behavior therapy VR CBT using low-cost cardboard virtual reality goggles compared with a wait-list control group and to determine its user friendliness We hypothesize that children with GAD enrolled in the self-guided app will present lower scores of anxiety
Detailed Description:
A randomized controlled design will be carried out in which the effectiveness and user- friendliness of an online app-based VR self-help treatment 0-anxiety will be evaluated Our primary objective is to determine the clinical effects a reduction in anxiety symptoms at post-test between the experimental condition and controls of 0-anxiety and whether effects are sustainable at follow-up a reduction in anxiety symptoms between baseline and follow-up for those in the experimental condition Our secondary objective is to determine the user-friendliness of 0-anxiety In this study 230 children from the Brazilian population will be randomized over 2 conditions the experimental condition 0-anxiety and a waitlist condition The duration of the intervention will be 3 weeks Measures will be taken at baseline directly after the intervention 3 weeks and at 3 months follow-up All measures will be completed online Therefore the child will participate in the study in hisher natural environment Subjects in the wait-list condition will receive the intervention after completion of the post-test Randomization block-randomization will be performed by an independent researcher
Study Oversight
Has Oversight DMC:
None
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?:
None