BACKGROUND Co-design is a collaborative approach involving end users, stakeholders, and designers in creating digital tools for healthcare. This study focuses on the co-design and evaluation of Behavior Emotion Therapy System and You (BETSY), a mental health chatbot and digital human for mild to moderate anxiety. OBJECTIVE To develop and evaluate BETSY through a co-design process involving potential users. METHODS The study employed a mixed-methods approach across three phases. Phase 1 involved recruiting 87 volunteer participants through social media for initial end-user requirements. Phase 2 focused on the design process based on end-user requirements employing the expertise of 10 stakeholders in healthcare and health service user. Phase 3 evaluated of the two prototyped interfaces (text-only chatbot and voice-interactive digital human chatbot) through 45 healthy volunteers. RESULTS For phase 1, 60.7% of participants had previous experience with chatbots and 85.7% expressed a willingness or potential willingness to use a chatbot for mental health support. Thematic analysis in phase 2 revealed key user preferences for a personalized, non-judgmental chatbot with a clear identity and focus on empathy. Privacy concerns and the need for clear interaction guidelines were highlighted. In phase 3, the users showed a strong preference for discussing anxiety related to work, relationships, and health. Both text-only and voice-interactive digital human users considered BETSY valuable for managing mild to moderate anxiety and providing self-help exercises. CONCLUSIONS The co-design process yielded valuable insights for developing BETSY. While users recognized its potential as an accessible first step before seeking professional help, they also identified areas for improvement, including more nuanced conversation capabilities and a broader range of exercises. BETSY's potential as a screening tool for healthcare was consistently acknowledged, suggesting its capability for alleviation of healthcare system burdens. CLINICALTRIAL No trial registration
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