Digital CBT-I for Chronic Insomnia

NCT06695000 | Not Yet Recruiting

• 1 other identifier: WCTP-I-C-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Insomnia Chronic; Insomnia Disorder

Outcome Measures

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.

  "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)

  From baseline to 6 weeks post-intervention

• Change from Baseline in Epworth Sleepiness Scale (ESS) Score at Post-Intervention (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)

  From baseline to 6 weeks post-intervention

• Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score at Post-Intervention (6 Weeks)

  From baseline to 6 weeks post-intervention

• Change from Baseline in Quality of Life (SF-36) Score at Post-Intervention (6 Weeks)

  From baseline to 6 weeks post-intervention

Other Outcomes (1)

• System Usability Scale (SUS) Score for Digital CBT-I at Post-Intervention (6 Weeks)

  6 weeks post-intervention

Study Arms (2)

digital CBT-I

EXPERIMENTAL

Device: digital CBT-I

Waitlist Control

NO INTERVENTION

Interventions

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.

Also known as: digital cognitive behavioral therapy for insomnia, SleepQ

digital CBT-I

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• WELT corp: lead

Study Sites (5)

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, 10380, South Korea

Location

Yongin Severance Hospital

Yongin-si, Gyeonggi-do, 16995, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, Seoul, 03722, South Korea

Location

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, Seoul, 06591, South Korea

Location

Ewha Womans University Medical Center

Seoul, Seoul, 07804, South Korea

Location

Related Publications (1)

• 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.

  PMID: 40636932 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Yujin Lee, Chief Medical Officer, MD

CONTACT

+82-2-6439-0707; info@weltcorp.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 19, 2024
• Study Start: January 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: March 1, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)