A Study on the Effectiveness of a Guided E-health Sleep and Biological Clock Intervention in University Students (i-Sleep & BioClock)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 195
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index
研究概览
简要总结
This randomized controlled trials aims to assess the effectiveness of an online guided self-help intervention ('i-Sleep & BioClock') based on CBTi principles for university students' sleep problems. The study will involve 192 students with subthreshold insomnia who will be randomized to the intervention or online psychoeducation. The intervention consists of 5 modules completed in about 5 weeks, supported by e-coaches. Outcomes include insomnia severity, mental health symptoms, functioning, quality of life, and academic performance, measured at baseline, post-treatment (6 weeks after baseline), and 18 weeks follow-up.
详细描述
Rationale: University students often suffer from sleep problems which affect their mental health and daily functioning. Cognitive behavioural therapy for insomnia (CBTi) has been proven effective in adults, but research in university students is still limited. The investigators hypothesize that a guided e-health self-help intervention based on CBTi principles ('i-Sleep & BioClock') could offer convenient treatment to students with sleep problems by reducing insomnia severity and improving mental health outcomes.
Objective: The aim of this randomized controlled trial is to assess the effectiveness of a guided e-health sleep and biological clock intervention on sleep, mental health symptoms (depression and anxiety), functioning, quality of life, and academic performance in university students.
Study design: This is a two-arm parallel group superiority randomized controlled trial, comparing a guided e-health intervention based on CBTi to online psychoeducation (PE).
Study population: The aim is to include 192 university students (Bachelor, Master and PhD) with at least subthreshold insomnia (Insomnia Severity Index ≥ 10), aged ≥ 16, who are able to speak Dutch or English, and are affiliated to one of the nine participating universities. Students with current suicidal ideation are excluded.
Intervention: The intervention will be a guided e-health intervention based on CBTi principles (i-Sleep & BioClock). It consists of 5 modules, to be completed in about 5 weeks, and is aimed at improving sleep in university students. The intervention will be entirely held online and will be supported by e-coaches.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being fluent in Dutch and/or English
- •Being enrolled as a student (Bachelor, Master or PhD) in one of the Caring Universities partner universities
- •Being ≥ 16 years old
- •Having self-reported sleep problems; Insomnia Severity Index ≥ 10
排除标准
- •Regular night shifts (Not being able to comply to the intervention due to regular night shift, meaning work between 2AM and 6AM at least once a week)
- •Current risk for suicidal behaviour
结局指标
主要结局
Insomnia Severity Index
时间窗: Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
7-item self-report instrument to assess insomnia severity, scores 0-28, higher scores indicating more insomnia severity
次要结局
- Sleep efficiency (in minutes)(Change from week 1 to week 7)
- Total sleep time (in minutes)(Change from week 1 to week 7)
- Sleep onset latency (in minutes)(Change from week 1 to week 7)
- Wake after sleep onset (in minutes)(Change from week 1 to week 7)
- Early morning awakening (in minutes)(Change from week 1 to week 7)
- Time spent outside (in minutes)(Change from week 1 to week 7)
- Screen use before bed(Change from week 1 to week 7)
- Munich Chronotype Questionnaire (MCTQ)(Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3))
- Work and Social Adjustment Scale (WSAS)(Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3))
- Patient Health Questionnaire (PHQ-9)(Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3))
- Generalised Anxiety Disorder scale (GAD-7)(Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3))
- Mental Health Quality of Life questionnaire (MHQoL)(Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3))
- Academic performance(Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3))
- Dysfunctional beliefs and attitudes about sleep (DBAS-10)(Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2))
- Pre-Sleep Arousal Scale (PSAS)(Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2))
研究者
Philip Spinhoven
Prof. dr. Philip Spinhoven
Leiden University Medical Center