Digital Sleep Program for College Students with Insomnia

NCT06853106 | Recruiting DMC

• 1 other identifier: N202401041
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

Anxiety; Chronotypes; Daytime Sleepiness; Depression; Digital-based Sleep Management; Insomnia; Resilience; Sleep Reactivity; Mindfulness-based Breathing

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity:The Insomnia Severity Index (ISI)

  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.

  T0 = baseline; T1 = immediately after intervention; T2 = 4 weeks after intervention.

Secondary Outcomes (6)

• Daytime Sleepiness:The Epworth Sleepiness Scale (ESS)

  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

• 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

• 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

Other Outcomes (1)

• Chronotype: The Chinese version of the Morningness-Eveningness Questionnaire (MEQ)

  T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention

Study Arms (2)

Waitlist control group

OTHER

Participants in the waitlist control group will maintain their daily routines without receiving any intervention throughout the experiment.

Other: Waitlist control group

digital-based multimodal sleep management program

EXPERIMENTAL

Participants in the experimental group will receive a 4-week digital-based multimodal sleep management program.

Behavioral: digital-based multimodal sleep management program

Interventions

Waitlist control group OTHER

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.

Waitlist control group

digital-based multimodal sleep management program BEHAVIORAL

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.

digital-based multimodal sleep management program

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Medical University: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Taipei Medicine University

Taipei, 11031, Taiwan

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Disorders of Excessive Somnolence; Depression

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Pei-Shan Tsai, PhD

CONTACT

+886227361661; ptsai@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 28, 2025
• Study Start: April 24, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)