Mental health chatbots: what the evidence shows

Chatbots and conversational AI apps that deliver cognitive behavioral therapy exercises and emotional support, or take self-referrals and intake information for psychological therapy services.

These tools hold text conversations with patients or the public, deliver cognitive behavioral therapy exercises, or take self-referrals for therapy services. FDA's briefing for a November 2025 advisory committee said the agency had authorized fewer than 20 digital mental health devices, none of them AI-enabled, and listed software that helps patients maintain behavioral coping skills as an example of a function under enforcement discretion. A 2023 meta-analysis of 15 randomized trials found that AI conversational agents reduced symptoms of depression (Hedges' g 0.64) and distress but not overall psychological well-being.

States have begun to legislate, according to a 2026 analysis of statutes. Illinois's Wellness and Oversight for Psychological Resources Act, enacted in August 2025, restricts licensed clinicians' use of AI in diagnosis, treatment planning and therapeutic communication but excludes physicians. Nevada's AB406, in effect since July 2025, bars AI providers from offering tools that would deliver mental health care. Utah's HB452, in effect since May 2025, requires mental health chatbots to provide clear disclosure and bans the sale of identifiable health data, and a New York law in effect since November 2025 requires operators of AI companions to refer users to care when they detect suicidal thoughts.

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General information, not medical advice. Every fact links to its source, and the page shows the date it was last reviewed.