A Self-guided App-Based Virtual Reality Cognitive Behavior Therapy for Anxiety Disorder in Children
试验速览
- 阶段
- 不适用
- 入组人数
- 230
- 主要终点
- Anxiety levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Anxiety levels
时间窗: 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.
次要结局
- 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)
研究者
Laiana A. Quagliato
MD
Universidade Federal do Rio de Janeiro