Digital Sleep Program for College Students with Insomnia

Not Applicable

Recruiting

• Conditions: Insomnia

• Registration Number: NCT06853106
• Lead Sponsor: Taipei Medical University

Brief 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).

Study Timeline

• Study Start: 2024-04-24
• Status Verified: 2025-02
• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-24
• Study First Posted: 2025-02-28
• Last Update Posted: 2025-02-28
• Primary Completion: 2027-02-28
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Registered as a full-time student
2. Aged 18 to 26 years old
3. Experiencing insomnia for at least three months
4. Currently own and use a personal mobile device
5. Ability to read and speak Chinese
6. Not taking hypnotics, sedatives, or antidepressants
7. Not pregnant or lactating

Exclusion Criteria

1. Using a smartphone model that cannot support the app
2. Currently using other sleep program apps
3. Meeting a STOP-BANG score of ≥3

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Insomnia Severity:The Insomnia Severity Index (ISI)	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.

Secondary Outcome Measures

Name	Time	Method
Daytime Sleepiness:The Epworth Sleepiness Scale (ESS)	T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention.	The Epworth Sleepiness Scale (ESS) is a self-reported measure of daytime sleepiness, assessing the propensity to doze or fall asleep during eight common daily activities. Each situation is rated on a 4-point scale, ranging from 0 ("would never doze") to 3 ("high chance of dozing"). The total score, obtained by summing the scores of the eight items, ranges from 0 to 24, with higher scores indicating greater levels of daytime sleepiness.
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	The Ford Insomnia Response to Stress Test (FIRST) measures the extent to which sleep is affected by stress in individuals experiencing stressful conditions. It is a self-administered questionnaire consisting of nine questions, each rated on a 4-point scale, ranging from 1 (unlikely to happen) to 4 (very likely to happen). The total score ranges from 9 to 36, with higher scores indicating a greater degree of sleep disruption due to stress.
Sleep Parameters	T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention	The sleep parameters will be recorded using a wearable sleep tracker (oCare Wrist-Worn Pro 100, Taiwan Biophotonic Corporation, Taiwan) daily for five consecutive days both before and immediately after the intervention. The wearable device will be paired with a mobile app for data collection and analysis. The sleep parameters derived from the device include sleep onset latency (SOL), wake after sleep onset (WASO), time in bed (TIB), total sleep time (TST), and sleep efficiency (SE).
Resilience: The Chinese version of the Brief Resilience Scale (BRS)	T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention	The Brief Resilience Scale (BRS) consists of six questions, each rated on a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree). Questions 1, 3, and 5 are forward-scored, while questions 2, 4, and 6 are reverse-scored. The total score ranges from 5 to 25, with higher scores indicating greater resilience, reflecting an individual's ability to adapt and recover from adverse events.
Depression: The Beck Depression Index II (BDI II)	T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention	The Beck Depression Inventory-II (BDI-II) is a 21-item questionnaire designed to assess depressive symptoms. Response options range from 0 (did not feel it) to 3 (most or almost all the time). The total score ranges from 0 to 63, with higher scores indicating greater severity of depressive symptoms.
Anxiety: The State Trait Anxiety Inventory (STAI)	T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention	The State-Trait Anxiety Inventory (STAI) is a self-report scale used to assess anxiety symptoms. It consists of 40 items, divided into two distinct dimensions: trait anxiety (20 items) and state anxiety (20 items). Each item is rated on a 4-point Likert scale, ranging from "almost never" to "almost always", with higher scores indicating greater levels of anxiety.

Trial Locations

Locations (1)

Taipei Medicine University; 🇨🇳 Taipei, Taiwan