Study of Efficacy of WELT-IP in Insomnia (WCTP-I-B-01)

A Multicenter, Randomized, Double-blinded, Sham-controlled Clinical Trial to Evaluate the Safety and Efficacy of Digital Cognitive Behavioral Therapy for Insomnia

The purpose of the study was to determine safety and efficacy of WELT-IP in adult insomnia patients. WELT-IP is a cognitive behavioral therapy for insomnia (CBT-I) based digital therapeutics.

This was a randomized, double-blinded, sham-controlled trial. Overall, 52 subjects were randomized into the following groups:

• WELT-IP group: WELT-IP (insomnia digital therapeutics) use
• Control group: sham app use Subjects in both groups continued to receive their clinician-directed standard-of-care treatment for insomnia, if applicable, including pharmacotherapy. Subjects were randomized and in WELT-IP group used WELT-IP and subjects in control group used a sham for a period of 6 weeks.

Inclusion Criteria:

• DSM-5 insomnia patient
• ISI of 8 or above
• for 7 days before baseline visit (Visit 2), completing sleep diary for more than 4 days in the guidelines
• capable of using mobile device and application

Exclusion Criteria:

• currently on non-pharmacological treatment for insomnia (ex. CBT-I, light therapy, oriental therapy for insomnia)
• sleep disorders diagnosis other than insomnia (ex. Obstructive sleep apnea, sleep behavior problem, restless leg syndrome)
• progressive and active medical conditions
• received continuous psychotherapy such as CBT, motivational enhancement therapy, psychotherapy, and psychoanalysis in the past 3 months
• major psychiatric illness as assessed through MINI
• suicide risk as assessed through C-SSRS
• having occupational risk due to sleep restriction
• shift workers