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

NCT04868201 | Unknown DMC

• 1 other identifier: 74646917.1.0000.5263
• Study Type: interventional
• Target: 230
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anxiety Disorders

Keywords

anxiety; virtual reality; app; self-guided; Cognitive behavior therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Fear Survey Schedule for Children-Revised (FSSC-R)

  baseline, 3 weeks after the intervention, and 3 months after the completion of the intervention

• Spence Children's Anxiety Scale - Parent and Children version

  baseline, 3 weeks after the intervention, and 3 months after the completion of the intervention

Study Arms (2)

0-anxiety

EXPERIMENTAL

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

wait-list condition

NO INTERVENTION

Interventions

0-anxiety DEVICE

0-anxiety is a self-guided app-based utilizing virtual reality establish in cognitive behavior therapy treatment.

0-anxiety

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

MeSH Terms

Conditions

Anxiety Disorders; Alzheimer Disease

Condition Hierarchy (Ancestors)

Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: April 30, 2021
• Study Start: August 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: April 30, 2021

Record last verified: 2021-04