NCT07576686Recruiting
AI-Guided CBT for Depression and Anxiety
The Significance of Artificial Intelligence-Guided Psychotherapy of Depression and Anxiety Disorders
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 1 May 2026
- Start date
- 7 Jan 2026
- Primary completion date
- 15 May 2026
- Lead sponsor
- Aleksandra Stojanovic
- Diseases
- Depression
- NCT number
- NCT07576686
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 7 Jan 2026 to the primary completion date, 15 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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-
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Clinical Center NIS Coordinator of this site? Confirm its status | Niš | Serbia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.