Clinical trial Recruiting at 1 site Interventional Ages 18 and up

AI-guided cognitive behavioral therapy for depression and anxiety

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

Run by Clinical Center Niš · NCT07576686 · Data updated 2026-11-12

This program will try an AI-guided online CBT to see if it helps adults with mild depression or anxiety.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment120 (estimated)
SponsorClinical Center Niš
Academic / other
Locations1 site (Niš)
StatusRecruiting
StartedJanuary 7, 2026
Main results expectedMay 15, 2026
Study endsJune 10, 2026
Registry record updatedMay 8, 2026
Trial IDNCT07576686 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 or older with a confirmed diagnosis of mild depressive disorder and/or an anxiety disorder who can use a smartphone, tablet, or computer and are willing to attend weekly 10-week sessions are ideal candidates.

Probably not a fit

People with moderate to severe depression, bipolar disorder, psychotic disorders, severe cognitive impairment, acute suicidal risk, or those unable to use digital tools are unlikely to benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This controlled clinical trial will compare an AI-guided cognitive behavioral therapy program delivered via a digital platform with standard psychiatric care in adults with mild depressive and/or anxiety disorders. Eligible participants recruited from outpatient services at the University Clinical Center Niš will be allocated to either the AI-guided CBT arm or a control arm receiving usual care. The intervention consists of weekly 45–60 minute structured sessions over 10 weeks, delivered through the digital platform with clinician supervision. Outcomes will be measured at baseline, mid-treatment (5 weeks), and post-treatment (10 weeks).

Why it matters

Potential benefit: If successful, the program could expand access to evidence-based CBT by providing a scalable, AI-supported option for people with mild depression or anxiety.

How similar studies have gone: Previous digital and guided CBT programs have shown effectiveness for mild-to-moderate depression and anxiety, though fully AI-guided approaches remain relatively new and are still being tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
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-

Where it's running

  • University Clinical Center Niš
    Niš, Serbia
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.