Digital CBT-I for Chronic Insomnia

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Change from Baseline in Insomnia Severity Index (ISI) Score at Post-Intervention [Срок оценки: "From baseline (Visit 1) to post-intervention assessment at 6 weeks]

Вторичные конечные точки (10)

• Change from Baseline in Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) Score at Post-Intervention (6 Weeks) [Срок оценки: From baseline to 6 weeks post-intervention]
• Change from Baseline in Epworth Sleepiness Scale (ESS) Score at Post-Intervention (6 Weeks) [Срок оценки: From baseline to 6 weeks post-intervention]
• Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score at Post-Intervention (6 Weeks) [Срок оценки: From baseline to 6 weeks post-intervention]
• Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score at Post-Intervention (6 Weeks) [Срок оценки: From baseline to 6 weeks post-intervention]
• Change from Baseline in Quality of Life (SF-36) Score at Post-Intervention (6 Weeks) [Срок оценки: 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) [Срок оценки: From baseline to 6 weeks post-intervention]
• Change from Baseline in Sleep Efficiency at Post-Intervention (6 Weeks) [Срок оценки: From baseline to 6 weeks post-intervention]
• Change from Baseline in Sleep Onset Latency at Post-Intervention (6 Weeks) [Срок оценки: From baseline to 6 weeks post-intervention]
• Change from Baseline in Wake After Sleep Onset at Post-Intervention (6 Weeks) [Срок оценки: From baseline to 6 weeks post-intervention]
• Change from Baseline in Total Sleep Time at Post-Intervention (6 Weeks) [Срок оценки: From baseline to 6 weeks post-intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 5 центров

• 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

Публикации

• 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

Идентификаторы

NCT: NCT06695000 · WCTP-I-C-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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