Can Artificial Intelligence Heal Human Hearts? A randomized controlled trial on the effects of internet cognitive behavioral therapy with artificial intelligence on depression (Japanese)

Background: In spite of recent high expectations of internet-based cognitive behavioral therapy (iCBT), iCBT still holds limitations including effect sustainability, function improvement, and dropout. Therefore, we focused on iCBT-AI in which automatic feedback by text or animation expressing empathy or indicating instruction is given to users with respect to their input after analysis conducted by a natural language processing (NLP) system, which is one area of artificial intelligence (AI). Since there is no evidence of iCBT using AI technology so far, we evaluated its effectiveness. Methods: 1,187 participants recruited from the website were randomly assigned into three groups; iCBT-AI, conventional iCBT without AI, and waitlist as control. Those allocated to interventional arms were encouraged to perform each exercise at least once a week for seven weeks. The primary outcome was moderate-to-severe depression defined as a PHQ-9 score of 10 or higher. Intention-to-treat analyses were performed. Results: The dropout rate was significantly lower in iCBT-AI than iCBT (p Conclusion: Although iCBT-AI has no significant short-term antidepressant effect, iCBT-AI seems to have an exclusive potential to reduce moderate-to-severe depression in the future. Further research is required.