Feasibility and Preliminary Effectiveness of a Blended E-health Intervention for Improving Sleep and the Biological Clock Among 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
- 101
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index
研究概览
简要总结
Students often suffer from sleep problems and circadian rhythm disruptions which affect their mental health and daily functioning. The aim of this project is to develop, implement and evaluate an e-health intervention that targets the biological clock and improves the sleep patterns of university students in order to prevent the development or exacerbation of mental health problems. The investigators will assess the feasibility, usability and acceptability of the intervention in this pilot trial.
详细描述
The primary objective of this study is to evaluate the e-health modules, in terms of overall acceptability, feasibility, and usability. The secondary objective is to evaluate preliminary effectiveness on the outcomes mentioned below.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- 否
入选标准
- •Being fluent in Dutch and/or English
- •Being enrolled as a student (Bachelor, Master or PhD) in one of the seven participating universities (Leiden University, Vrije Universiteit Amsterdam, Utrecht University, Maastricht University, Erasmus University Rotterdam, University of Amsterdam, Inholland University of Applied Sciences)
- •Being ≥ 16 years old
- •Having self-reported sleep problems; Insomnia Severity Index ≥ 8 (at least subthreshold insomnia)
排除标准
- •Current risk for suicidal behaviour
结局指标
主要结局
Insomnia Severity Index
时间窗: Change from baseline (T0) to 7 weeks after baseline (T1)
7-item self-report instrument to assess insomnia severity, scores 0-28, higher scores indicating more insomnia severity
次要结局
- Work and Social Adjustment Scale (WSAS)(Change from baseline (T0) to 7 weeks after baseline (T1))
- Sleep and light exposure diary(Change from week 0 (7 days prior to intervention period) to week 8 (7 days after T1))
- Patient Health Questionnaire (PHQ-9)(Change from baseline (T0) to 7 weeks after baseline (T1))
- Mental Health Quality of Life questionnaire (MHQoL)(Change from baseline (T0) to 7 weeks after baseline (T1))
- Munich Chronotype Questionnaire (MCTQ)(Change from baseline (T0) to 7 weeks after baseline (T1))
- Generalised Anxiety Disorder scale (GAD-7)(Change from baseline (T0) to 7 weeks after baseline (T1))
研究者
Philip Spinhoven
Prof. Philip Spinhoven
Leiden University Medical Center