Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2025-01-31
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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digital CBT-I
digital CBT-I
The intervention is a digital Cognitive Behavioral Therapy for Insomnia (CBT-I) program, delivered via a mobile application. The program includes structured, self-guided modules focusing on sleep hygiene education, cognitive restructuring, stimulus control, bed time restriction, and relaxation techniques. Each module offers interactive exercises and weekly assignments designed to support behavior change and improve sleep. Participants will receive app-based reminders to encourage regular engagement, with features for tracking progress and adherence throughout the 6 week program.
Waitlist Control
No interventions assigned to this group
Interventions
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digital CBT-I
The intervention is a digital Cognitive Behavioral Therapy for Insomnia (CBT-I) program, delivered via a mobile application. The program includes structured, self-guided modules focusing on sleep hygiene education, cognitive restructuring, stimulus control, bed time restriction, and relaxation techniques. Each module offers interactive exercises and weekly assignments designed to support behavior change and improve sleep. Participants will receive app-based reminders to encourage regular engagement, with features for tracking progress and adherence throughout the 6 week program.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has experienced insomnia symptoms for 3 months or longer.
* Scores 8 or higher on the Insomnia Severity Index (ISI).
* Oral and written fluency in Korean
* Owns a smartphone and is independently able to use apps on a smartphone.
* Voluntarily agrees to participate in this clinical study and provides signed informed consent.
Exclusion Criteria
* Diagnosed with other sleep disorders aside from insomnia and currently symptomatic, such as:
* Obstructive sleep apnea (G47.30)
* Sleep behavior disorders
* Restless leg syndrome (G28.8)
* Narcolepsy (G47.4)
* Has an active, ongoing physical illness that impedes daily functioning, such as:
* Congestive heart failure
* Chronic obstructive pulmonary disease (COPD)
* Acute pain
* Neurological disorders (e.g., cerebrovascular disease)
* Neurodegenerative disorders (e.g., dementia, multiple sclerosis)
* Unstable medical conditions or life expectancy of less than 6 months
* Adjustments in schedule or dosage of sleep medications, antidepressants, anticonvulsants, anxiolytics, or antipsychotics within the past 3 months, or use of PRN (as needed) prescribed sleep medications.
* Engaged in shift work.
* Pregnant individuals or those planning to become pregnant during the study period.
* Any condition that the investigator believes would make participation in the study not in the best interest of the participant or would preclude successful completion of study activities
19 Years
ALL
No
Sponsors
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WELT corp
INDUSTRY
Responsible Party
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Locations
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Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, South Korea
Yongin Severance Hospital
Yongin-si, Gyeonggi-do, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul, South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, Seoul, South Korea
Ewha Womans University Medical Center
Seoul, Seoul, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Moon DU, Kim J, Sun JH, Lee Y. Applying a mobile intervention for chronic insomnia in routine care: Study protocol for a multicenter randomized controlled trial. Internet Interv. 2025 Jun 20;41:100848. doi: 10.1016/j.invent.2025.100848. eCollection 2025 Sep.
Other Identifiers
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WCTP-I-C-01
Identifier Type: -
Identifier Source: org_study_id
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