Actively Recruiting
The Significance of Artificial Intelligence-Guided Psychotherapy of Depression and Anxiety Disorders
Led by Aleksandra Stojanovic · Updated on 2026-05-08
120
Participants Needed
1
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of an artificial intelligence (AI)-guided cognitive behavioral therapy (CBT) program for adults with mild depression and anxiety disorders. These mental health conditions are widespread and burdensome, yet access to psychotherapy is limited. This controlled clinical trial aims to compare AI-guided CBT with standard psychiatric care to explore how AI might improve access to and delivery of mental health treatment. Participants will be assigned to one of two groups: an experimental group receiving AI-guided CBT through a digital platform, and a control group receiving standard psychiatric care. The AI-guided CBT involves structured weekly sessions lasting 45 to 60 minutes over 10 weeks, conducted under clinical supervision. The control group will receive routine clinical monitoring and treatment as determined by their clinician without access to the AI intervention. During the study, participants will undergo assessments at the start, mid-treatment (week 5), and after treatment completion (week 10). Researchers will measure changes in depression and anxiety symptoms, perceived stress, social support, digital therapeutic alliance, and overall clinical improvement. Data collection involves standardized scales and clinical impression assessments. Participants will provide informed consent, and data will be handled following ethical and privacy standards.
CONDITIONS
Brief Title
AI-Guided CBT for Depression and Anxiety
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 weeks
Participants receive weekly structured cognitive behavioral therapy (CBT) sessions over a 10-week period. The sessions last approximately 45-60 minutes and are conducted either through an AI-guided digital platform or by a trained therapist in a clinical setting under supervision.
Weekly visits for 10 weeks
Trial Site Locations
Total: 1 location
1
University Clinical Center Niš
Niš, Serbia, 18000
Actively Recruiting
Research Team
A
Aleksandra Stojanovic, MD, PhD Candidate
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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