NCT05809544

Study of Efficacy of WELT-IP in Insomnia (WCTP-I-B-02)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: WELT corp · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This was a randomized, double-blinded, sham-controlled trial. Overall, 68 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. After screening of sleep diary, 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.

Conditions

• Insomnia

Interventions

Type	Name	Description
DEVICE	WELT-IP	WELT-IP (an investigational digital therapeutic) is an CBT-I based intervention designed to treat insomnia, conducted in 6 sessions. It is a comprehensive program delivering sleep restriction, stimulation control, muscle relaxation, cognitive treatment, and sleep hygiene education. Main features are sleep diary, sleep reports, daily lessons of CBT-I, muscle relaxation techniques, and cognitive intervention through chatbot.
DEVICE	Sham	Sham was downloaded to the subject's phone and was subject was instructed to complete sleep diary and sleep educational contents as needed.

Timeline

• Start date: 2022-10-14
• Primary completion: 2023-02-20
• Completion: 2023-02-20
• First posted: 2023-04-12
• Last updated: 2023-04-12

Locations

1 site across 1 country: South Korea