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Not yet recruiting NCT06695000

Digital CBT-I for Chronic Insomnia

No phase Interventional Insomnia Chronic Insomnia Disorder

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: digital CBT-I.
Who it may be relevant to
Registry conditions: Insomnia Chronic, Insomnia Disorder. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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 engagem

Primary outcome measures

  • 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]
Secondary outcome measures (10)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 5 centers
  • Inje University Ilsan Paik Hospital — Goyang-si
  • Yongin Severance Hospital — Yongin-si
  • Severance Hospital, Yonsei University Health System — Seoul
  • The Catholic University of Korea, Seoul ST. Mary's Hospital — Seoul
  • Ewha Womans University Medical Center — Seoul

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. PMID 40636932

Identifiers

NCT: NCT06695000 · WCTP-I-C-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗