Digital CBT-I for Chronic Insomnia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorWELT corp
About this trial
This study evaluates the effectiveness and safety of a digital Cognitive Behavioral Therapy program for Insomnia (CBT-I) in individuals with chronic insomnia. Participants will be randomly assigned to either begin digital CBT-I immediately or join a wait-list.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Meets diagnostic criteria for insomnia disorder according to the International Classification of Diseases, 10th Revision (ICD-10), including: F51: Nonorganic sleep disorders; G47: Sleep disorders
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
Disqualifiers
Currently receiving non-pharmacological treatments for insomnia (e.g., CBT-I, light therapy, traditional medicine for sleep) within the past 3 months from screening.
Obstructive sleep apnea (G47.30)
Sleep behavior disorders
Restless leg syndrome (G28.8)
Trial design
Design model
Parallel
Treatments tested in this trial
digital CBT-I
DeviceThe 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: digital CBT-IExperimental treatment 1 intervention
Group B: Waitlist ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change from Baseline in Insomnia Severity Index (ISI) Score at Post-Intervention
The Insomnia Severity Index (ISI) measures the severity of insomnia symptoms, with scores ranging from 0 to 28. Higher scores indicate more severe insomnia, with 0-7 representing no clinically significant insomnia, 8-14 mild insomnia, 15-21 moderate insomnia, and 22-28 severe insomnia. This outcome measures the change in ISI score from baseline to 6 weeks, comparing changes between the digital CBT-I group and the waitlist control group.
Time frame
"From baseline (Visit 1) to post-intervention assessment at 6 weeksSecondary outcomes
1
Change from Baseline in Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) Score at Post-Intervention (6 Weeks)
The DBAS-16 measures maladaptive beliefs about sleep, with scores ranging from 0 to 160. Higher scores indicate more dysfunctional beliefs. This outcome evaluates the change in DBAS-16 score from baseline to 6 weeks, comparing changes between the digital CBT-I group and the waitlist control group.
Time frame
From baseline to 6 weeks post-intervention2
Change from Baseline in Epworth Sleepiness Scale (ESS) Score at Post-Intervention (6 Weeks)
The ESS measures daytime sleepiness, with scores ranging from 0 to 24. Higher scores indicate greater sleepiness, with scores above 10 suggesting excessive daytime sleepiness. This outcome assesses the change in ESS score from baseline to 6 weeks
Time frame
From baseline to 6 weeks post-intervention3
Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score at Post-Intervention (6 Weeks)
The PHQ-9 measures the severity of depressive symptoms, with scores ranging from 0 to 27. Higher scores indicate more severe depression, with categories of mild, moderate, moderately severe, and severe depression. This outcome evaluates the change in PHQ-9 score from baseline to 6 weeks, comparing changes between the digital CBT-I group and the waitlist control group.
Time frame
From baseline to 6 weeks post-intervention4
Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score at Post-Intervention (6 Weeks)
The GAD-7 measures the severity of generalized anxiety symptoms, with scores ranging from 0 to 21. Higher scores indicate greater anxiety, with categories of mild, moderate, and severe anxiety. This outcome assesses the change in GAD-7 score from baseline to 6 weeks, comparing changes between the digital CBT-I group and the waitlist control group.
Time frame
From baseline to 6 weeks post-interventionOther outcomes
1
System Usability Scale (SUS) Score for Digital CBT-I at Post-Intervention (6 Weeks)
The SUS assesses usability of the digital CBT-I intervention, with scores ranging from 0 to 100. Higher scores indicate better usability, with scores above 68 considered above average. This outcome evaluates user experience and satisfaction with the digital CBT-I program.
Time frame
6 weeks post-intervention Source ClinicalTrials.gov
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