Digital-Based Multimodal Sleep Management Program for College Students with Insomnia: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Insomnia Severity:The Insomnia Severity Index (ISI)
研究概览
简要总结
This randomized controlled trial (RCT) study aims to evaluate the effectiveness of a digital-based multimodal sleep management program compared to a waitlist control group in improving sleep-related outcomes, including insomnia severity, daytime sleepiness, objective sleep parameters, and sleep reactivity to stress, as well as psychological health indices, such as depression, anxiety, and resilience. Additionally, this study seeks to examine the mediating role of different chronotypes in the effectiveness of the sleep intervention on the outcomes of interest.
详细描述
This is a parallel-group, randomized controlled trial (RCT). 90 participants who experiencing insomnia for at least 3 months with college students will be enrolled.
Eligible participants who complete the baseline measurements will be randomly allocated to a digital-based multimodal sleep management program group (N = 45) and a waitlist control group (N = 45).
The primary outcome is insomnia severity, assessed using the Insomnia Severity Index (ISI). The secondary outcomes include daytime sleepiness, objective sleep parameters, sleep reactivity, resilience, anxiety, and depression, which will be examined using the Epworth Sleepiness Scale (ESS), a wearable sleep tracker, the Ford Insomnia Response to Stress Test (FIRST), the Brief Resilience Scale (BRS), the State-Trait Anxiety Inventory (STAI), and the Beck Depression Index II (BDI-II), respectively. Additionally, chronotype will be assessed using the Morningness-Eveningness Questionnaire (MEQ) as a moderating role to be tested in this study. All outcomes will be measured at three time points: T0 (baseline assessment), T1 (immediately after the 4-week intervention period), and T2 (4 weeks after the intervention period).
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
We will implement a double-masking protocol, ensuring that assessors and data collectors are all blinded to group assignments. Additionally, group assignments will also be masked from the data analyzer to minimize potential bias.
入排标准
- 年龄范围
- 18 Years 至 26 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Registered as a full-time student
- •Aged 18 to 26 years old
- •Experiencing insomnia for at least three months
- •Currently own and use a personal mobile device
- •Ability to read and speak Chinese
- •Not taking hypnotics, sedatives, or antidepressants
- •Not pregnant or lactating
排除标准
- •Using a smartphone model that cannot support the app
- •Currently using other sleep program apps
- •Meeting a STOP-BANG score of ≥3
研究组 & 干预措施
Waitlist control group
Participants in the waitlist control group will maintain their daily routines without receiving any intervention throughout the experiment.
干预措施: Waitlist control group (Other)
digital-based multimodal sleep management program
Participants in the experimental group will receive a 4-week digital-based multimodal sleep management program.
干预措施: digital-based multimodal sleep management program (Behavioral)
结局指标
主要结局
Insomnia Severity:The Insomnia Severity Index (ISI)
时间窗: T0 = baseline; T1 = immediately after intervention; T2 = 4 weeks after intervention.
The Insomnia Severity Index (ISI) consists of seven items that assess the current perception of the severity of three insomnia symptoms. Each item is rated on a 5-point Likert scale, with the total score ranging from 0 to 28. Higher scores indicate greater severity of insomnia.
次要结局
- Daytime Sleepiness:The Epworth Sleepiness Scale (ESS)(T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention.)
- Sleep Reactivity: The Chinese version of the Ford Insomnia Response to Stress Test (FIRST)(T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention)
- Sleep Parameters(T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention)
- Resilience: The Chinese version of the Brief Resilience Scale (BRS)(T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention)
- Depression: The Beck Depression Index II (BDI II)(T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention)
- Anxiety: The State Trait Anxiety Inventory (STAI)(T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention)
研究者
Pei-Shan, Tsai
Principal Investigator
Taipei Medical University