Recruiting

AI-Guided CBT for Depression and Anxiety

ClinicalTrials.gov IDNCT07576686

PhaseNA

Enrollment120

SponsorAleksandra Stojanovic

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Depression - Major Depressive Disorder, Anxiety Disorders

About this study

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.

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.

Primary outcomes

Change in depressive symptom severity (Baseline, week 5, and week 10)
Change in anxiety symptom severity (Baseline, week 5, and week 10)

Eligibility information

Inclusion Criteria: Age 18 years or older Diagnosis of mild depressive disorder and/or anxiety disorder confirmed by a structured clinical interview (MINI) Ability to understand and provide informed consent Access to a device capable of using the digital platform (computer, tablet, or smartphone) Willingness to participate in weekly sessions over a 10-week period Exclusion Criteria: Moderate to severe depressive disorder Current or past diagnosis of psychotic disorder Bipolar disorder Substance use disorder or dependence Primary diagnosis of antisocial personality disorder Severe cognitive impairment or inability to use digital tools Acute suicidal risk requiring immediate intervention Concurrent participation in another structured psychotherapy program-

Study locations

University Clinical Center Niš, Niš, 18000 Serbia

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.