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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Device: 0-anxiety


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0-anxiety<br>0-anxiety is based on the principles of VRT and CBT, which currently is the most researched and used treatment for anxiety disorders. The 0-anxiety intervention is an app-based intervention consisting of six modules that can be followed according to a user's own timing and without the intervention of a therapist. | Device: 0-anxiety<br>* 0-anxiety is a self-guided app-based utilizing virtual reality establish in cognitive behavior therapy treatment.<br>|
| No Intervention: wait-list condition<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, virtual reality, app, self-guided, Cognitive behavior therapy