NCT04868201

A Self-guided App-Based Virtual Reality Cognitive Behavior Therapy for Anxiety Disorder in Children

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Universidade Federal do Rio de Janeiro · Academic / Other
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Not accepted

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 his/her 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.

Conditions

• Anxiety Disorders

Interventions

Type	Name	Description
DEVICE	0-anxiety	0-anxiety is a self-guided app-based utilizing virtual reality establish in cognitive behavior therapy treatment.

Timeline

• Start date: 2021-08-01
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2021-04-30
• Last updated: 2021-04-30