Digital CBT-I for Chronic Insomnia

November 15, 2024 updated by: WELT corp

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Yujin Lee, Chief Medical Officer, MD
  • Phone Number: +82-2-6439-0707
  • Email: info@weltcorp.com

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
        • Contact:
          • Eun Lee, MD, PhD
          • Phone Number: +82-02-2228-1620
          • Email: leeeun@yuhs.ac
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
        • Contact:
      • Seoul, Korea, Republic of, 07804
        • Ewha Womans University Medical Center
        • Contact:
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10380
        • Inje University Ilsan Paik Hospital
        • Contact:
      • Yongin-si, Gyeonggi-do, Korea, Republic of, 16995
        • Yongin Severance Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Waitlist Control
Experimental: digital CBT-I
Device: 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 Names:
  • digital cognitive behavioral therapy for insomnia
  • SleepQ

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
"From baseline (Visit 1) to post-intervention assessment at 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
From baseline to 6 weeks post-intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
System Usability Scale (SUS) Score for Digital CBT-I at Post-Intervention (6 Weeks)
Time Frame: 6 weeks post-intervention
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.
6 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
WELT corp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WCTP-I-C-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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