Mental Health Generative AI is Safe, Promotes Social Health, and Reduces Depression and Anxiety: Real World Evidence from a Naturalistic Cohort

Generative artificial intelligence (GAI) chatbots built for mental health could deliver safe, personalized, and scalable mental health support. We evaluate a foundation model designed for mental health. Adults completed mental health measures while engaging with the chatbot between May 15, 2025 and September 15, 2025. Users completed an opt-in consent, demographic information, mental health symptoms, social connection, and self-identified goals. Measures were repeated every two weeks up to 6 weeks, and a final follow-up at 10 weeks. Analyses included effect sizes, and growth mixture models to identify participant groups and their characteristic engagement, severity, and demographic factors. Users demonstrated significant reductions in PHQ-9 and GAD-7 that were sustained at follow-up. Significant improvements in Hope, Behavioral Activation, Social Interaction, Loneliness, and Perceived Social Support were observed throughout and maintained at 10 week follow-up. Engagement was high and predicted outcomes. Working alliance was comparable to traditional care and predicted outcomes. Automated safety guardrails functioned as designed, with 76 sessions flagged for risk and all handled according to escalation policies. This single arm naturalistic observational study provides initial evidence that a GAI foundation model for mental health can deliver accessible, engaging, effective, and safe mental health support. These results lend support to findings from early randomized designs and offer promise for future study of mental health GAI in real world settings.