Insomnia ChronicNCT06695000
Digital CBT-I for Chronic Insomnia
A study testing digital CBT-I in people with Insomnia Chronic and Insomnia Disorder, run by WELT corp at 5 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Insomnia Chronic, Insomnia Disorder
- What is being tested?
- digital CBT-I
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Jan 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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.
Who cannot join
- Currently receiving non-pharmacological treatments for insomnia (e.g., CBT-I, light therapy, traditional medicine for sleep) within the past 3 months from screening.
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
South Korea5 sites
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, 10380
Pamela Song, MD, +82-31-910-7847, songpama7@gmail.com
Severance Hospital, Yonsei University Health System
Seoul, Seoul, 03722
Eun Lee, MD, PhD, +82-02-2228-1620, leeeun@yuhs.ac
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, Seoul, 06591
Junhee Lee, MD, +82-2-2258-6080, j.lee@snu.ac.kr
Ewha Womans University Medical Center
Seoul, Seoul, 07804
Jeehyun Kim, MD, +82/2-6986-3562, jeehkim26@ewha.ac.kr
Yongin Severance Hospital
Yongin-si, Gyeonggi-do, 16995
Woojung Kim, MD, +82-10-9282-7943, WOOJUNGKIM@yuhs.ac
About this study
Official title: A Multi-Site, Randomized, Wait-List Controlled Trial to Assess the Effectiveness and Safety of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) in Patients with Chronic Insomnia
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.
Read the detailed description
This multi-site, randomized, wait-list controlled trial investigates the effectiveness and safety of a digital Cognitive Behavioral Therapy for Insomnia (CBT-I) program in treating chronic insomnia. Participants will be randomly assigned to start the digital CBT-I immediately or after a wait period. The digital CBT-I program, includes modules on sleep education, cognitive restructuring, stimulus control, sleep restriction, and relaxation techniques. Primary and secondary outcomes will measure insomnia severity, beliefs about sleep, daytime sleepiness, mood, quality of life, productivity, and sleep efficiency. Findings aim to assess the effectiveness of digital CBT-I in improving sleep and daily functioning among chronic insomnia patients in South Korea.
- Conditions
- Insomnia Chronic, Insomnia Disorder
- Being tested
- digital CBT-I
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital CBT-IDevice
Also called digital cognitive behavioral therapy for insomnia, SleepQ
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.
| Study group | Role | What they receive |
|---|---|---|
| digital CBT-I | Experimental | Not described Receives: Device: digital CBT-I |
| Waitlist Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "From baseline (Visit 1) to post-intervention assessment at 6 weeks
Secondary outcomes (10)
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.
Measured: From baseline to 6 weeks post-intervention
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
Measured: From baseline to 6 weeks post-intervention
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.
Measured: From baseline to 6 weeks post-intervention
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.
Measured: From baseline to 6 weeks post-intervention
Change from Baseline in Quality of Life (SF-36) Score at Post-Intervention (6 Weeks)
The SF-36 assesses overall quality of life across multiple domains, with higher scores indicating better quality of life. Scores range from 0 to 100 for each subscale. This outcome measures the change in SF-36 score from baseline to 6 weeks, comparing changes between the digital CBT-I group and the waitlist control group.
Measured: From baseline to 6 weeks post-intervention
Change from Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI-SHP) Score at Post-Intervention (6 Weeks)
The WPAI-SHP assesses work productivity and impairment in daily activities, with scores from 0% to 100%, where higher scores indicate greater impairment. This outcome measures the change in WPAI-SHP score from baseline to 6 weeks, comparing changes between the digital CBT-I group and the waitlist control group.
Measured: From baseline to 6 weeks post-intervention
Change from Baseline in Sleep Efficiency at Post-Intervention (6 Weeks)
Sleep Efficiency (SE) measures the percentage of time spent asleep while in bed, calculated as total sleep time divided by time in bed. Higher values indicate improved sleep efficiency. This outcome assesses the change in SE from baseline to 6 weeks.
Measured: From baseline to 6 weeks post-intervention
Change from Baseline in Sleep Onset Latency at Post-Intervention (6 Weeks)
Sleep Onset Latency (SOL) measures the time (in minutes) it takes to transition from wakefulness to sleep. Lower values indicate improved sleep onset. This outcome assesses the change in SOL from baseline to 6 weeks.
Measured: From baseline to 6 weeks post-intervention
Change from Baseline in Wake After Sleep Onset at Post-Intervention (6 Weeks)
Wake After Sleep Onset (WASO) measures the time (in minutes) spent awake after initially falling asleep until final awakening. Lower values indicate improved sleep continuity. This outcome assesses the change in WASO from baseline to 6 weeks.
Measured: From baseline to 6 weeks post-intervention
Change from Baseline in Total Sleep Time at Post-Intervention (6 Weeks)
Total Sleep Time (TST) measures the total duration of sleep (in minutes) during the night. Higher values indicate improved sleep duration. This outcome assesses the change in TST from baseline to 6 weeks.
Measured: From baseline to 6 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study startJan 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WELT corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695000
- Sponsor's protocol ID
- WCTP-I-C-01
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40636932
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site, Randomized, Wait-List Controlled Trial to Assess the Effectiveness and Safety of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) in Patients with Chronic Insomnia
- ClinicalTrials.gov ID
- NCT06695000
- Acronym / sponsor ID
- WCTP-I-C-01
- Conditions
- Insomnia Chronic, Insomnia Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- WELT corpIndustry (pharma, biotech, devices)
- Study start
- Jan 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This multi-site, randomized, wait-list controlled trial investigates the effectiveness and safety of a digital Cognitive Behavioral Therapy for Insomnia (CBT-I) program in treating chronic insomnia. Participants will be randomly assigned to start the digital CBT-I immediately or after a wait period. The digital CBT-I program, includes modules on sleep education, cognitive restructuring, stimulus control, sleep restriction, and relaxation techniques. Primary and secondary outcomes will measure insomnia severity, beliefs about sleep, daytime sleepiness, mood, quality of life, productivity, and sleep efficiency. Findings aim to assess the effectiveness of digital CBT-I in improving sleep and daily functioning among chronic insomnia patients in South Korea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| digital CBT-I | Experimental | Device: digital CBT-I |
| Waitlist Control | No intervention | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Owns a smartphone and is independently able to use apps on a smartphone.
Key exclusion criteria (17 listed)
- Currently receiving non-pharmacological treatments for insomnia (e.g., CBT-I, light therapy, traditional medicine for sleep) within the past 3 months from screening.
- Diagnosed with other sleep disorders aside from insomnia and currently symptomatic, such as:
- Has an active, ongoing physical illness that impedes daily functioning, such as:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital CBT-IAlso: digital cognitive behavioral therapy for insomnia, SleepQThe 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. | Device | digital CBT-I |
Primary outcome
Change from Baseline in Insomnia Severity Index (ISI) Score at Post-Intervention
Time frame: "From baseline (Visit 1) to post-intervention assessment at 6 weeks
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.
10 secondary outcomes
Change from Baseline in Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) Score at Post-Intervention (6 Weeks)
Time frame: From baseline to 6 weeks post-intervention
Change from Baseline in Epworth Sleepiness Scale (ESS) Score at Post-Intervention (6 Weeks)
Time frame: From baseline to 6 weeks post-intervention
Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score at Post-Intervention (6 Weeks)
Time frame: From baseline to 6 weeks post-intervention
Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score at Post-Intervention (6 Weeks)
Time frame: From baseline to 6 weeks post-intervention
Change from Baseline in Quality of Life (SF-36) Score at Post-Intervention (6 Weeks)
Time frame: From baseline to 6 weeks post-intervention
Change from Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI-SHP) Score at Post-Intervention (6 Weeks)
Time frame: From baseline to 6 weeks post-intervention
Change from Baseline in Sleep Efficiency at Post-Intervention (6 Weeks)
Time frame: From baseline to 6 weeks post-intervention
Change from Baseline in Sleep Onset Latency at Post-Intervention (6 Weeks)
Time frame: From baseline to 6 weeks post-intervention
Change from Baseline in Wake After Sleep Onset at Post-Intervention (6 Weeks)
Time frame: From baseline to 6 weeks post-intervention
Change from Baseline in Total Sleep Time at Post-Intervention (6 Weeks)
Time frame: From baseline to 6 weeks post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Derived from this study: PubMed 40636932Moon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital CBT-I in people with Insomnia Chronic and Insomnia Disorder, run by WELT corp at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yujin Lee, Chief Medical Officer, MD (+82-2-6439-0707, info@weltcorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Insomnia Severity Index (ISI) Score at Post-Intervention (time frame: "From baseline (Visit 1) to post-intervention assessment at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06695000, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.