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RECRUITING
NCT07576686
NA

AI-Guided CBT for Depression and Anxiety

Sponsor: Aleksandra Stojanovic

View on ClinicalTrials.gov

Summary

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.

Official title: The Significance of Artificial Intelligence-Guided Psychotherapy of Depression and Anxiety Disorders

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-01-07

Completion Date

2026-06-10

Last Updated

2026-05-08

Healthy Volunteers

No

Interventions

BEHAVIORAL

AI-Guided Cognitive Behavioral Therapy

AI-guided cognitive behavioral therapy delivered through a digital platform, consisting of structured weekly sessions over 10 weeks.

BEHAVIORAL

Cognitive Behavioral Therapy (CBT)

Cognitive behavioral therapy delivered by a trained therapist in a standard clinical format, consisting of structured weekly sessions over a 10-week period.

Locations (1)

University Clinical Center Niš

Niš, Serbia