Clinical trial NCT06853106: Digital Sleep Program for College Students with Insomnia
Official title: Digital-Based Multimodal Sleep Management Program for College Students with Insomnia: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Keywords: Anxiety
Chronotypes
Daytime Sleepiness
Depression
Digital-based Sleep Management
Insomnia
Resilience
Sleep Reactivity
Mindfulness-based Breathing
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2025-02-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Insomnia Severity:The Insomnia Severity Index (ISI)
timeFrame: T0 = baseline; T1 = immediately after intervention; T2 = 4 weeks after intervention.
Secondary outcomes:
measure: Daytime Sleepiness:The Epworth Sleepiness Scale (ESS)
timeFrame: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention.
measure: Sleep Parameters
timeFrame: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention
measure: Sleep Reactivity: The Chinese version of the Ford Insomnia Response to Stress Test (FIRST)
timeFrame: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention
measure: Resilience: The Chinese version of the Brief Resilience Scale (BRS)
timeFrame: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention
measure: Depression: The Beck Depression Index II (BDI II)
timeFrame: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention
measure: Anxiety: The State Trait Anxiety Inventory (STAI)
timeFrame: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention
Other outcomes:
measure: Chronotype: The Chinese version of the Morningness-Eveningness Questionnaire (MEQ)
timeFrame: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medicine University
Study officials:
References: