NCT06853106

Digital Sleep Program for College Students with Insomnia

Digital-Based Multimodal Sleep Management Program for College Students with Insomnia: Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Taipei Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 26 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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).

Conditions

• Insomnia

Interventions

Type	Name	Description
OTHER	Waitlist control group	The participants in the waitlist control group will be informed that they are on a waiting list during the intervention period, serving as a no-treatment control. They will receive the sleep intervention (i.e., the digital-based sleep management program) four weeks after the intervention period is completed.
BEHAVIORAL	digital-based multimodal sleep management program	The digital-based multimodal sleep management program consists of (1) sleep hygiene education, (2) sleep restriction, and (3) mindfulness breathing exercises. The program is internet-integrated and delivered via Google Meet, with 45-minute weekly sessions over four weeks. To increase participants' adherence to the sleep management program , the course instructor will request the participants to record their daily sleep diaries (time to bed, time to sleep, wake time during sleep and wake time) and sleep journals(practices of sleep hygiene, sleep restriction and mindfulness breathing exercise) in the mobile app for at least five consecutive days each week.

Timeline

• Start date: 2024-04-24
• Primary completion: 2027-02-28
• Completion: 2027-07-31
• First posted: 2025-02-28
• Last updated: 2025-02-28

Locations

1 site across 1 country: Taiwan