Digital CBT-I for Chronic Insomnia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorWELT corp
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Currently receiving non-pharmacological treatments for insomnia (e.g., CBT-I, light therapy, traditional medicine for sleep) within the past 3 months from screening.
Obstructive sleep apnea (G47.30)
Sleep behavior disorders
Restless leg syndrome (G28.8)
Trial design
Treatments tested in this trial
- digital CBT-I
Treatment groups
120 Participants
are divided into 2 treatment groupsLocations
5Inje University Ilsan Paik Hospital10380, Goyang-siGyeonggi-do, South Korea
Yongin Severance Hospital16995, Yongin-siGyeonggi-do, South Korea
Ewha Womans University Medical Center07804, SeoulSeoul, South Korea
Severance Hospital, Yonsei University Health System03722, SeoulSeoul, South Korea
Sponsors and collaborators
WELT corp
Lead sponsor
Source ClinicalTrials.gov