Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 558
- 试验地点
- 2
- 主要终点
- Change in insomnia symptom severity change
研究概览
简要总结
The "SleepFix Study" is a clinical trial designed to evaluate the efficacy of mobile-delivered sleep restriction therapy (dBTi) in comparison to digital sleep health education (control) for treating insomnia disorder in adults aged 18 and above. The study is conducted entirely online, with 558 participants (279 in each group) and aims to determine the impact of the interventions on insomnia symptom severity, sleep metrics, subjective sleep quality, fatigue, anxiety, depressive symptoms, quality of life, medication usage, and workforce productivity.
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)
盲法说明
The research staff and Principal Chief Investigator will not be blinded to the study as they will be managing the online study directly which will lend itself to knowing which groups participants are allocated to. All other Investigators including data analysts will be blinded throughout the course of the trial and analysis of primary and secondary outcomes. Participants will not be blinded as they will know what treatment they receive.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥ 18 years
- •Able to give informed online consent
- •Insomnia Severity Index ≥ 12
- •English fluency
- •Access to a smartphone and willingness/proficiency to use a mobile application
排除标准
- •Shift-workers (at least 2 night shifts a week between the hours of 8 pm to 8 am)
- •Serious medical and/or psychiatric illnesses/disorders
- •Previously diagnosed or suspected/high-risk of undiagnosed sleep disorders (e.g. REM Sleep Behaviour Disorder, Restless Leg Syndrome
- •Currently receiving Cognitive Behavioural Therapy for insomnia (CBT-i)
- •Operators of machinery that require high alertness (e.g. truck drivers, train drivers, pilots, etc)
- •Pregnant women
结局指标
主要结局
Change in insomnia symptom severity change
时间窗: 8 weeks
Insomnia Severity Index (ISI) is a 7-item questionnaire used to examine overall insomnia severity. It consists of a five-point Likert type scale for each item (ranging from "no problem" = 0 to "severe problem" = 28) regarding symptoms over the past 2 weeks. Scores range from 0-28 with higher scores indicating greater insomnia symptom severity.
次要结局
- Change in quality of life scores(8 weeks)
- Change in sleep-wake metrics(8 weeks)
- Daytime symptoms of fatigue(8 weeks)
- Treatment usability(8 weeks)
- Workforce productivity(8 Weeks)
- Change in anxiety scores(8 weeks)
- Change in depressive symptom scores(8 weeks)
- Sleep medication usage(8 weeks)