Targeting Worry to Improve Sleep Using App-Based Mindfulness Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in Worry-related Sleep Disturbances
研究概览
简要总结
The purpose of this study is to test an app-based mindfulness training program for worry to see if it can help individuals decrease worry and improve sleep.
详细描述
In this study, 80 individuals with worry interfering with sleep will be randomized to receive Unwinding Anxiety or to Treatment as Usual (50/50 chance). The active intervention period will last 2 months, with an optional 2-month follow-up period in which the intervention remains available. Changes in mindfulness, emotional reactivity, cognition and sleep behavior at specified time points will be measured. The primary engagement targets will be non-reactivity and worry. The primary behavioral outcome target will be sleep.
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
- •Score > 40 on the Penn State Worry Questionnaire (PSWQ)
- •Score ≥ to 40% on Worry Interfering with Sleep Scale (WISS)
- •Owns a smartphone
- •Willing to wear a sleep tracker for at least 1 week
排除标准
- •Any usage of psychotropic medication: not on a stable dosage 6+ weeks
- •Medical disorder of the severity that would interfere with ability to attend visits and complete study milestones
- •Use of benzodiazepine or hypnotic sleep aid on as needed (i.e. prn)
- •Known sleep disorder
- •Psychotic disorder
- •Post-traumatic Stress Disorder
- •Severe depression (Score > 3 on PHQ-2)
- •Current shift work employment
- •BMI > 35
- •Evening caffeine use
- •Pregnant women
结局指标
主要结局
Change in Worry-related Sleep Disturbances
时间窗: Baseline, 2 months
5 questions from the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29) pertaining to anxiety and sleep will be used to assess worry-related sleep disturbances over the past 7 days. These questions are on a 5-point Likert scale where 1 is "Not at all" and 5 is "Very much". Scores can range from 5 to 25 and higher scores indicate a worse outcome.
次要结局
- Changes in Non-reactivity(Baseline, 2 months)
- Change in Worry(Baseline, 2 months)
- Change in Total Sleep Time (TST)(Baseline, 2 months)