AI-guided cognitive behavioral therapy for depression and anxiety
The Significance of Artificial Intelligence-Guided Psychotherapy of Depression and Anxiety Disorders
This program will try an AI-guided online CBT to see if it helps adults with mild depression or anxiety.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinical Center Niš Academic / other |
| Locations | 1 site (Niš) |
| Trial ID | NCT07576686 on ClinicalTrials.gov |
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).
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Niš
- University Clinical Center Niš — Niš, Serbia (Recruiting)
Study contacts
- Study coordinator: Aleksandra Stojanovic, MD, PhD Candidate
- Email: drakiwatson@gmail.com
- Phone: +381642293541
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.