Artificial Intelligence–Augmented Cognitive Behavioral Therapy as a Treatment for Depression and Anxiety: A Comparative Study with Other Non-Pharmacological Therapies in Pakistani Adult

Abstract

Background: Depression and anxiety impose a substantial burden on Pakistan's adult population, yet access to evidence-based psychological care remains constrained by workforce shortages, cost, and stigma. We evaluated whether culturally adapted, AI-augmented cognitive behavioral therapy (AI-CBT) is non-inferior to therapist-delivered CBT and superior to psychoeducation/mindfulness for treating mild-to-moderate depression and anxiety in primary care settings. Methods: In this three-arm, assessor-blinded, randomized controlled trial, 321 adults (18–65 years; PHQ-9 ≥10 and/or GAD-7 ≥8) from urban and peri-urban clinics across Pakistan were randomized to: (1) Urdu-adapted AI-CBT (NLP-driven conversational agent + asynchronous clinician oversight), (2) therapist-delivered CBT, or (3) structured psychoeducation/mindfulness. Primary outcomes were changes in PHQ-9 and GAD-7 scores at 8 weeks. Analyses followed intention-to-treat using linear mixed-effects models with a pre-specified non-inferiority margin (Δ=1.5). Results: At 8 weeks, AI-CBT demonstrated non-inferior reductions in depressive (mean difference vs. therapist CBT: −0.4, 95% CI −1.0 to 0.2; p<0.01) and anxiety symptoms (−0.3, 95% CI −0.9 to 0.3; p<0.01), and was superior to psychoeducation/mindfulness (PHQ-9: −3.8, 95% CI −4.5 to −3.1; GAD-7: −3.2, 95% CI −3.9 to −2.5; both p<0.001). AI-CBT achieved higher intervention completion (78% vs. 64%; p<0.001), equivalent acceptability, and a 62% lower cost per QALY. Benefits were sustained at 12 weeks, with no serious adverse events reported. Conclusion: Culturally adapted AI-augmented CBT is a clinically non-inferior, cost-effective, and scalable non-pharmacological treatment for depression and anxiety in Pakistani adults. Integration of AI-delivered mental health interventions into primary care offers a pragmatic strategy to expand access and reduce the treatment gap in resource-constrained health systems.