Digital CBT-I for Chronic Insomnia

WELT corp

Status

Not yet enrolling

Conditions

Insomnia Disorder

Insomnia Chronic

Treatments

Device: digital CBT-I

Study type

Interventional

Funder types

Industry

Identifiers

NCT06695000

WCTP-I-C-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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