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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 10
- Primary Endpoint
- Change from Baseline in Insomnia Severity Index (ISI) Score at Post-Intervention
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- 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)
- Change from Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI-SHP) Score at Post-Intervention (6 Weeks)(From baseline to 6 weeks post-intervention)
- Change from Baseline in Sleep Efficiency at Post-Intervention (6 Weeks)(From baseline to 6 weeks post-intervention)
- Change from Baseline in Sleep Onset Latency at Post-Intervention (6 Weeks)(From baseline to 6 weeks post-intervention)
- Change from Baseline in Wake After Sleep Onset at Post-Intervention (6 Weeks)(From baseline to 6 weeks post-intervention)
- Change from Baseline in Total Sleep Time at Post-Intervention (6 Weeks)(From baseline to 6 weeks post-intervention)