AI cognitive-behavioral therapy trial, major depressive disorder, Taiwan

ClinicalTrials.gov published registration NCT07500714 for a Phase 2 interventional study examining the efficacy and safety of an AI cognitive-behavioral therapy application (Woebot) as an adjunct treatment for adults with major depressive disorder (MDD). The single-site trial at National Taiwan University Hospital will enroll approximately 30 participants receiving the AI intervention alongside standard pharmacological treatment for a 10-week treatment period with a 4-week follow-up phase. Primary endpoints include change in PHQ-9 depression severity scores and response rates, with secondary assessments of patient compliance, satisfaction, and adverse events.

Clinical trial sponsors and investigators conducting human subjects research should ensure their trials are properly registered on ClinicalTrials.gov per FDAAA 801 requirements. Sites in Taiwan conducting FDA-regulated trials should verify compliance with local clinical trial regulations and Taiwan FDA requirements. Research ethics committees should review AI-based intervention protocols to ensure adequate informed consent procedures address AI participation in patient care.