Digital CBT-I for Chronic Insomnia

Launched by WELT CORP · Nov 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a digital program called Cognitive Behavioral Therapy for Insomnia (CBT-I) designed for people with chronic insomnia, which is a long-term difficulty in falling or staying asleep. Participants will be randomly chosen to either start the digital CBT-I program right away or be placed on a wait-list to begin later. The goal is to see if this online therapy can help improve sleep quality for those struggling with insomnia.

To be eligible for the study, participants must have been experiencing insomnia symptoms for at least three months and have a score of 8 or higher on a sleep severity questionnaire. They should also be fluent in Korean, own a smartphone, and be comfortable using apps. However, individuals currently undergoing other sleep treatments or those with certain medical conditions that affect sleep will not be able to participate. The trial will provide a convenient way for participants to engage in therapy from home, which could lead to better sleep and improved daily functioning.

Gender

ALL

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