Clinical Effectiveness of Digital CBT-I for the Treatment of Insomnia Disorder: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 336
- 试验地点
- 1
- 主要终点
- Change in the Insomnia Severity Index (ISI)
研究概览
简要总结
This study will examine the effectiveness of digital CBT-I versus sleep hygiene education in reducing insomnia severity, sleep onset latency, and wake after sleep onset in those with insomnia disorder.
详细描述
This study aims to examine the effectiveness of a fully-automated web and app-based digital CBT-I for insomnia compared to sleep hygiene education (SHE) in individuals with a diagnosis of insomnia disorder. Primary outcomes of interest include changes in insomnia severity, sleep onset latency, and wake after sleep onset throughout the course of the study.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥22 years old
- •Insomnia Disorder diagnosis
- •Score ≤16 on the 8-item Sleep Condition Indicator
- •> 30 minutes sleep onset latency (SOL); and/or > 30 minutes wake after sleep onset (WASO)
- •Current resident of the USA
- •Oral and written fluency in English
- •Participant is able and willing to comply with protocol requirements, has been informed of the nature of the study, and has signed the IRB-approved informed consent form
排除标准
- •Must not be currently receiving or be expecting to start CBT for insomnia during study participation, or have previously received CBT for insomnia in the past 12-months (self-report)
- •If on psychoactive medication, including sleep medication, this must be stable for at least 5 half lives
- •Past or present psychosis, schizophrenia, bipolar disorder, assessed by self-report and/or seizure disorder
- •Occupation that requires alertness / caution to avoid accidents, for example long-haul driving, long distance bus driver, heavy machinery operator, air traffic controller
- •Hearing or vision impairment that prevents effective use of the audio-visual content of digital CBT-I or SHE in the opinion of the investigator
- •Intellectual disability or any Neurocognitive or Neurodevelopmental disorder that would prevent participants from following study procedures
- •Any condition that the investigator believes would make participation in the study not in the best interest of the participant or would preclude successful completion of study activities
研究组 & 干预措施
Digital CBT-I
Digitally-delivered CBT for insomnia accessed via web and/or mobile app
干预措施: digital CBT-I (Device)
Sleep hygiene education
This group will receive access to sleep hygiene education delivered via digital written materials
干预措施: Sleep hygiene education (Other)
结局指标
主要结局
Change in the Insomnia Severity Index (ISI)
时间窗: From baseline to 10 weeks post-randomization
Validated questionnaire; a 7-item scale with total scores between 0 and 28 where higher scores indicate greater severity
Change in sleep onset latency (SOL)
时间窗: From baseline to 10 weeks post-randomization
Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days
Change in wake after sleep onset (WASO)
时间窗: From baseline to 10 weeks post-randomization
Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days
次要结局
- Insomnia Disorder remission (score <8) and response (change ≥6) on the ISI(10, 16, and 24 weeks post-randomization)
- Insomnia disorder remission based on the SCID Insomnia Module(Week -1 compared to weeks 10, 16, and 24 post-randomization)
- Change in sleep diary parameters: percent sleep efficiency (SE), total sleep time (TST), total time in bed (TTIB), and total wake time (TWT)(From lead-in period to 10, 16, and 24 weeks post-randomization)
- Change in the Sleep Condition Indicator (SCI-8)(From baseline to weeks 10, 16, and 24 post-randomization)
- Change in the Insomnia Severity Index (ISI)(From baseline to weeks 16 and 24 post-randomization)
- Change in sleep onset latency (SOL)(From baseline to weeks 16 and 24 post-randomization)
- Change in the Patient Health Questionnaire (PHQ-8)(From baseline to weeks 10, 16 and 24 post-randomization)
- Change in wake after sleep onset (WASO)(From baseline to weeks 16 and 24 post-randomization)
- Change in the Generalized Anxiety Disorder Questionnaire (GAD-7)(From baseline to weeks 10, 16, and 24 post-randomization)