Comparing Internet and In-Person Brief Cognitive Behavioral Therapy of Insomnia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 2
- 主要终点
- Sleep Diary Sleep Efficiency
研究概览
简要总结
The objective of this study is to directly compare 6 sessions of in-person and Internet administered Cognitive-Behavior Therapy for Insomnia (CBTi) to a Minimal Contact control (MC), within an active duty military population to determine the comparative benefits of these interventions on improvement in sleep as well as domains strongly related to insomnia such as depression, substance abuse, and PTSD symptoms. A total of 189 military personnel with chronic insomnia, aged 18-65, will be recruited and randomized to receive 6-sessions (over 6 weeks) of CBTi (n=77), ICBTi (n=35), or a MC control (n=77) condition. The investigators will compare these three groups on subjective and objective measures of sleep. The CBTi and MC control groups will be compared on other variables of interest (e.g., depression, substance abuse, and PTSD symptoms) and predictors of outcomes.
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
- •Chronic Insomnia as defined by Research Diagnostic Criteria (RDC) criteria41 Complaint of > 3 months (chronic insomnia) of disturbed sleep >3 nights/week (severe insomnia) as defined by at least one of the following as assessed by sleep diaries: Sleep Onset Latency of >30 min (initial insomnia) and/or Wake After Sleep-Onset of >30 min (middle insomnia) and/or Early Morning Awakening of >30 min before the desired wakeup time (late insomnia) and Sleep Efficiency < 85%
- •Active Duty military member stationed at Fort Hood as assessed by self-report.
- •History of having deployed in support of OIF or OEF as assessed by self-report. • Stable on psychotropic and/or hypnotic medications for at least one month as assessed by self-report and review of medical record.
排除标准
- 未提供
结局指标
主要结局
Sleep Diary Sleep Efficiency
时间窗: Change from Baseline to Post-Treatment and 6 month follow-up
Provides daily self-reports of bedtime, time to fall asleep, middle of the night awakenings, and time out of bed. These data will be aggregated to determine self-reported sleep efficiency (i.e., total sleep time/time in bed X 100). Other variable to be extracted will include total sleep time and total wake time.
次要结局
- Beck Depression Inventory II(Change from Baseline to Post-Treatment and 6 month follow-up)
- Substance Use(Change from Baseline to Post-Treatment and 6 month follow-up)
- Actigraphy(Change from Baseline to Post-Treatment and 6 month follow-up)
- PTSD Check List-Military(Change from Baseline to Post-Treatment and 6 month follow-up)
- Beck Anxiety Inventory(Change from Baseline to Post-Treatment and 6 month follow-up)
- Insomnia Severity Index(Change from Baseline to Post-Treatment and 6 month follow-up)
- Epworth Sleepiness Scale(Change from Baseline to Post-Treatment and 6 month follow-up)
- Dysfunctional Beliefs and Attitudes About Sleep Scale(Change from Baseline to Post-Treatment and 6 month follow-up)
- Multidimensional Fatigue Inventory(Change from Baseline to Post-Treatment and 6 month follow-up)
- Veterans Rand 12-Item Health Survey(Change from Baseline to Post-Treatment and 6 month follow-up)
研究者
Daniel J. Taylor, Ph.D.
Professor
University of North Texas, Denton, TX