Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06695000

Digital CBT-I for 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Insomnia Chronic Dyssomnias Insomnia Disorder Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inje University Ilsan Paik Hospital, Goyang-si, Gyeonggi-do, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital CBT-I

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yujin Lee, Chief Medical Officer, MD

CONTACT

[email protected]

+82-2-6439-0707

Sponsors and collaborators

Lead sponsor

WELT corp

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Nov 19, 2024
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.