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

NCT ID: NCT04868201

Last Updated: 2021-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-02-01

Brief Summary

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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

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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.

Conditions

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Anxiety Disorders

Keywords

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anxiety virtual reality app self-guided Cognitive behavior therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

0-anxiety

Intervention Type DEVICE

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

wait-list condition

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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0-anxiety

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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Laiana A. Quagliato

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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74646917.1.0000.5263

Identifier Type: -

Identifier Source: org_study_id