Insomnia Clinical Trial
Official title:
A 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, 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. ;
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