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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04868201
• Other study ID #: 74646917.1.0000.5263
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: April 2021
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 230
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• individuals must be between 8-12 years old;
• subjects must score above 25 on the SCARED questionnaire;
• subjects must have access to a smart phone and internet;
• individuals must be willing to participate in the research study and providing informed consent.

Exclusion Criteria:

• children that present with symptoms of severe depression or suicidality as measured with KSADS-PL26;
• children that have insufficient knowledge of the Portuguese language;
• subjects that are under any current treatment for anxiety disorder or using psychotropic medication.

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Device:
• 0-anxiety
0-anxiety is a self-guided app-based utilizing virtual reality establish in cognitive behavior therapy treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety levels	Screen for Child Anxiety Related Disorders (SCARED). A score above 25 indicates a significant level of anxiety. Higher scores mean worse anxiety levels.	baseline and and 3 months after the completion of the intervention
Secondary	Fear Survey Schedule for Children-Revised (FSSC-R)	The FSSC-R is a widely used self-report measure of children and adolescents' fears. The instrument, a revision of Scherer and Nakamura's (1968) original Fear Survey Schedule for Children, contains 80 items that are each rated on a three-point scale (none, some, a lot). A total fearfulness score can be obtained, as can five subscale scores based on a factor analysis of the items. In addition, the number of intense fears can be indicated (i.e., the number of fears endorsed 'a lot'), as can the most prevalent fears for a given child/adolescent or group of children and adolescents (i.e., boys, preadolescents, school phobic youngsters, etc.). Higher scores mean worse fear levels.	baseline, 3 weeks after the intervention, and 3 months after the completion of the intervention
Secondary	Spence Children's Anxiety Scale - Parent and Children version	The scale is completed by a parent of an anxious child between the ages of 6 to 18. It provides an overall measure of anxiety together with scores on six sub-scales each tapping a specific aspect of child anxiety. - Panic attack and agoraphobia - Separation anxiety - Physical injury fears - Social phobia - Obsessive compulsive - Generalized anxiety disorder / overanxious disorder. This yields a maximum possible score of 114. Higher scores mean worse anxiety levels.	baseline, 3 weeks after the intervention, and 3 months after the completion of the intervention