Digital Sleep Program for College Students with Insomnia (DSP-CS)

Taipei Medical University

Status: Enrolling

Conditions: Insomnia

Treatments: Behavioral: digital-based multimodal sleep management program; Other: Waitlist control group

Study type: Interventional

Funder types: Other

Identifiers

NCT06853106

N202401041

Details and patient eligibility

About

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.

Full 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).

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 26 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Waitlist control group

Other group

Description:

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

Treatment:

Other: Waitlist control group

digital-based multimodal sleep management program

Experimental group

Description:

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

Treatment:

Behavioral: digital-based multimodal sleep management program