AI-Guided CBT for Depression and Anxiety

This study aims to evaluate the effectiveness of an artificial intelligence (AI)-guided cognitive behavioral therapy (CBT) program for the treatment of mild depression and anxiety disorders in adults. Depression and anxiety disorders are among the most common mental health conditions worldwide and are associated with significant individual and societal burden. Despite the availability of effective treatments, access to psychotherapy remains limited due to insufficient resources and long waiting times. Digital mental health interventions, particularly those supported by artificial intelligence, have the potential to increase accessibility and scalability of evidence-based treatments. In this controlled clinical trial, participants diagnosed with mild depressive disorder and/or anxiety disorders will be assigned to either an experimental group receiving AI-guided CBT or a control group receiving standard psychiatric care. The intervention will be delivered through a digital platform and will consist of structured weekly sessions over a 10-week period. The primary objective of the study is to assess changes in symptoms of depression and anxiety. Secondary outcomes include perceived stress, social support, digital therapeutic alliance, and overall clinical improvement. The findings of this study are expected to contribute to the understanding of the role of AI in psychotherapy and its potential to improve access to mental health care.

NCT Number	NCT07576686
Lead Sponsor	Aleksandra Stojanovic
Conditions	Depression - Major Depressive Disorder, Anxiety Disorders
Enrollment	120 participants
Start Date	2026-01-07
Primary Completion	2026-05-15 (estimated)
Study Completion	2026-06-10 (estimated)
Updated on ClinicalTrials.gov	2026-05-08