Clinical trial NCT04868201: A Self-guided App-Based Virtual Reality Cognitive Behavior Therapy for Anxiety Disorder in Children
Official title: A Self-guided App-Based Virtual Reality Cognitive Behavior Therapy for Anxiety Disorder in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Disorders
Keywords: anxiety
virtual reality
app
self-guided
Cognitive behavior therapy
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 230
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anxiety levels
timeFrame: baseline and and 3 months after the completion of the intervention
Secondary outcomes:
measure: Fear Survey Schedule for Children-Revised (FSSC-R)
timeFrame: baseline, 3 weeks after the intervention, and 3 months after the completion of the intervention
measure: Spence Children's Anxiety Scale - Parent and Children version
timeFrame: baseline, 3 weeks after the intervention, and 3 months after the completion of the intervention
Other outcomes:
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