Real-World Testing of an Artificial Intelligence Conversational Agent as an Early Intervention and Support Tool in the Mental Health Referral Care Pathway: A Mixed-Methods Study

BACKGROUND: The incidence of mental health concerns is growing, and demand for support is exceeding service capacity. Digital tools can provide additional support but risk causing harm if not delivered safely. AIMS: We aimed to establish real-world evidence of the impact of an artificial intelligence-based mental health conversational agent (Wysa) on depression and anxiety in patients waiting for Talking Therapies treatment. METHODS: A mixed-methods randomized controlled trial was conducted with patients referred to Talking Therapies in the Central and Northwest London NHS Foundation Trust. The primary outcome was change in depression severity over 12 weeks between groups; secondary outcomes included anxiety severity, quality of life, safety, engagement, and app usage. Comparative analyses used linear regression; thematic analysis was conducted on qualitative data. RESULTS: = 4.38 and 3.82 for control). Results were similar for secondary outcomes. Wysa was potentially helpful, easy to use, and appreciated as an accessible source of support, but limitations with the conversational agent negatively affected engagement. CONCLUSIONS: Although sample size limited the analysis, participant feedback highlighted its potential to supplement clinical services. Our study findings suggest that the change of depression score is similar in both arms thus indicating that there is no evidence that Wysa treats depression in this study. However, limited sample size could have influenced this. Key lessons to improve the quality of effectiveness studies of digital health technologies were identified.