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

Universidade Federal do Rio de Janeiro

Status: Unknown

Conditions: Anxiety Disorders

Treatments: Device: 0-anxiety

Study type: Interventional

Funder types: Other

Identifiers

NCT04868201

74646917.1.0000.5263

Details and patient eligibility

About

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.

Full 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.

Enrollment: 230 estimated patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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230 participants in 2 patient groups

0-anxiety

Experimental group

Description:

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.

Treatment:

Device: 0-anxiety

wait-list condition

No Intervention group