Developing a Novel Digital Therapeutic for the Treatment of Generalized Anxiety Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Change in worry
研究概览
简要总结
The investigators propose to develop and adapt Unwinding Anxiety phone app specifically for individuals with generalized anxiety disorder.
详细描述
The study aims are to (1) develop and refine Unwinding Anxiety for individuals with generalized anxiety disorder, (2) determine user engagement and acceptability as well as measure effect sizes of the program vs. treatment as usual, and (3) preliminarily test mechanisms of action. The knowledge gained will set the stage for a number of future studies related to further elucidating the mechanisms of mindfulness, and the clinical efficacy and utility of this type of training delivered via digital therapeutics in general. Specifically, this study will provide necessary variances for powering larger phase 2 studies.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Owns a smart phone
- •GAD - 7 is equal to or greater than 10
排除标准
- •If using psychotropic medication - not on a stable dosage for at least 6 weeks
- •Medical disorder of the severity that would interfere with ability to participate
- •Not being fluent in English (due to instructions provided in English)
- •As needed use (i.e. prn) of benzodiazepines
- •Psychotic disorder,
- •Previous MT (e.g. MBSR, other Claritas MindSciences training programs).
结局指标
主要结局
Change in worry
时间窗: Baseline, two months
Penn State Worry Questionnaire (PSWQ)
UA Program engagement
时间窗: Two months
Number of modules completed
次要结局
- UA Program Acceptability(Two months)
- Change in non-reactivity & awareness(Baseline, two months)
研究者
Judson Brewer
Director of Research & Innovation
Brown University