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

April 27, 2021 updated by: Laiana A. Quagliato, Universidade Federal do Rio de Janeiro
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

230

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0-anxiety
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
0-anxiety is a self-guided app-based utilizing virtual reality establish in cognitive behavior therapy treatment.
No Intervention: wait-list condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety levels
Time Frame: 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.
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)
Time Frame: 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.
baseline, 3 weeks after the intervention, and 3 months after the completion of the intervention
Spence Children's Anxiety Scale - Parent and Children version
Time Frame: 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.
baseline, 3 weeks after the intervention, and 3 months after the completion of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio de Janeiro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

April 25, 2021

First Submitted That Met QC Criteria

April 27, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Actual)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 74646917.1.0000.5263

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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