Digital therapeutics and AI-assisted interventions

Software-based interventions (CBT apps, AI chatbots, VR exposure therapy) promise scalable mental health care but face challenges in clinical validation, engagement, and regulatory approval. Key open problems include maintaining therapeutic alliance without a human therapist, personalizing intervention timing and content via digital phenotyping, achieving durable outcomes beyond acute symptom reduction, and navigating FDA Software as a Medical Device (SaMD) pathways. Real-world evidence often shows high dropout rates and modest effect sizes.