AI-enabled conversational agent increases engagement with cognitive-behavioral therapy: A randomized controlled trial

Timely support after referral to mental healthcare is crucial, yet patients often face prolonged wait times without intervention. Digital mental health interventions offer scalable solutions, but many struggle to achieve acceptable patient engagement. Tailoring and personalizing materials to individual needs is paramount for driving engagement, a task that generative artificial intelligence AI (genAI) is potentially able to achieve. To examine this promise, we conducted a randomized controlled trial using a genAI-enabled therapy app, Limbic Care, which delivers personalized cognitive behavioral therapy (CBT) materials, against PDF workbooks delivering static CBT content, as commonly used in standard care. Adults with elevated symptoms of anxiety or depression (N = 540) were randomly assigned to the app or control group for six weeks. The app group exhibited a threefold increase in engagement (2.4 times higher usage frequency, 3.8 times longer usage durations). While both groups showed similar overall symptom improvement, participants who engaged with the app’s clinical personalization capabilities experienced significantly greater reductions in anxiety symptoms and enhanced well-being than those who engaged with the standard CBT materials. Importantly, the app was safe, with no increase in adverse events compared to standard care. Our findings suggest that genAI-enabled therapy apps can safely enhance patient engagement and improve clinical outcomes through clinically personalized interventions.