Anxiety Disorders
Conditions
Keywords
anxiety, virtual reality, app, self-guided, Cognitive behavior therapy
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.
Interventions
DEVICE0-anxiety
0-anxiety is a self-guided app-based utilizing virtual reality establish in cognitive behavior therapy treatment.
Sponsors
Universidade Federal do Rio de Janeiro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety levels | baseline and and 3 months after the completion of the intervention | Screen for Child Anxiety Related Disorders (SCARED). A score above 25 indicates a significant level of anxiety. Higher scores mean worse anxiety levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fear Survey Schedule for Children-Revised (FSSC-R) | baseline, 3 weeks after the intervention, and 3 months after the completion of the intervention | 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. |
| Spence Children's Anxiety Scale - Parent and Children version | baseline, 3 weeks after the intervention, and 3 months after the completion of the intervention | 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. |
Outcome results
None listed