Digital Sleep Program for College Students with Insomnia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Waitlist control group, digital-based multimodal sleep management program.
- Who it may be relevant to
- Registry conditions: Insomnia. Basic parameters: 18 years — 26 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Digital-Based Multimodal Sleep Management Program for College Students with Insomnia: Randomized Controlled Trial
Overview
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).
Interventions
- 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) an
Primary outcome measures
- Insomnia Severity:The Insomnia Severity Index (ISI) [Time frame: T0 = baseline; T1 = immediately after intervention; T2 = 4 weeks after intervention.]
Secondary outcome measures (6)
- Daytime Sleepiness:The Epworth Sleepiness Scale (ESS) [Time frame: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention.]
- Sleep Parameters [Time frame: 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) [Time frame: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention]
- Resilience: The Chinese version of the Brief Resilience Scale (BRS) [Time frame: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention]
- Depression: The Beck Depression Index II (BDI II) [Time frame: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention]
- Anxiety: The State Trait Anxiety Inventory (STAI) [Time frame: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Using a smartphone model that cannot support the app
- Currently using other sleep program apps
- Meeting a STOP-BANG score of ≥3
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Taipei Medicine University — Taipei
Identifiers
NCT: NCT06853106 · N202401041