A Study on Online Insomnia Treatment Programs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index
研究概览
简要总结
The purpose of this study is to investigate improvements in sleep by comparing two 6-week digital programs, either online or app-based, that deliver Cognitive Behavioral Therapy for Insomnia (CBT-I), the "gold standard" treatment for insomnia, with or without a bedside device to help track sleep.
详细描述
Time needed from participant: 15 minutes per day to complete an app-based or online sleep diary and review information in an app-based or online CBT-I program.
To qualify, you must:
Be 18+ years old Have a diagnosis of insomnia or suspected insomnia Have access to the internet and an iphone, Android or other smart phone device
Coordinator Contact:
Cris Moreno (650) 721-7576 crismore@stanford.edu
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 (Outcomes Assessor)
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
- •insomnia diagnosis or measure-confirmed moderate to severity insomnia (Insomnia Severity Index = 15-28)
- •access to an iPhone with iOS 11+ or Samsung, Google, HTC, LG, OnePlus, or Motorola phone with Android 10+
- •18 years of age or older
- •available 15 mins per day to participate
排除标准
- •Restless Legs Syndrome
- •narcolepsy
- •sleep apnea
- •sleep walking
- •bipolar disorder
- •seizures disorder
- •substance abuse
- •frailty/risk of falling
- •severe memory problems
- •shift work
- •change in antidepressant medication within past 2 months
- •serious mental/physical health problem
- •other ongoing psychological treatment w
- •sleeping with pets.
- •Participants should be aware that should they receive a device, its sound and light alerts could be disruptive to partners or others (e.g., children) that sleep in the same room.
结局指标
主要结局
Insomnia Severity Index
时间窗: Completion of program (6-8 weeks)
A measure of insomnia symptoms
次要结局
- Number of awakenings(Completion of program (6-8 weeks))
- Total sleep time(Completion of program (6-8 weeks))
- Sleep onset latency(Completion of program (6-8 weeks))
- Sleep efficiency(Completion of program (6-8 weeks))
- Wakefulness after sleep onset(Completion of program (6-8 weeks))