AI-Guided CBT for Depression and Anxiety (AI-CBT-DA)

May 1, 2026 updated by: Aleksandra Stojanovic

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is designed as a controlled clinical trial to investigate the effectiveness of an artificial intelligence (AI)-guided cognitive behavioral therapy (CBT) intervention in adults with mild depressive disorder and/or anxiety disorders.

Mental health disorders, particularly depression and anxiety, represent a major public health challenge. Although cognitive behavioral therapy is an evidence-based treatment, access to psychotherapy remains limited in many healthcare systems. AI-guided digital interventions may provide a scalable and accessible alternative or complement to traditional therapy.

Participants aged 18 years and older with a diagnosis of mild depression and/or anxiety disorders, confirmed using a structured diagnostic interview, will be recruited from outpatient services at the University Clinical Center Niš. Eligible participants will be allocated to one of two groups: (1) an experimental group receiving AI-guided CBT through a digital platform, and (2) a control group receiving standard psychiatric care.

The intervention will consist of weekly structured sessions lasting approximately 45-60 minutes over a period of 10 weeks. Sessions will be conducted using a digital platform designed to deliver CBT-based content with guidance from an AI system. The intervention will be conducted in a clinical setting with supervision by trained clinicians.

Assessments will be conducted at baseline, mid-treatment (after 5 weeks), and post-treatment (after 10 weeks). Outcome measures will include standardized scales for depression, anxiety, perceived stress, social support, and digital therapeutic alliance. Clinical global impression scales will also be used to evaluate overall improvement.

The study will also explore mechanisms of change, including the role of digital therapeutic alliance and cognitive-behavioral processes in symptom reduction.

All participants will provide informed consent prior to participation. Data will be anonymized and handled in accordance with ethical and data protection standards.

The results of this study are expected to provide evidence on the clinical utility of AI-guided psychotherapy and inform future integration of digital mental health interventions into routine clinical practice.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Aleksandra Stojanović, MD, PHD candidate
  • Phone Number: +381642293541
  • Email: drakiwatson@gmail.com

Study Locations

  • Serbia
      • Niš, Serbia, 18000
        • Recruiting
        • University Clinical Center Nis
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI-Guided CBT
Participants in this group will receive AI-guided cognitive behavioral therapy delivered through a digital platform. The intervention will consist of structured weekly sessions lasting 45-60 minutes over a period of 10 weeks, conducted under clinical supervision.
Behavioral: AI-Guided Cognitive Behavioral Therapy
AI-guided cognitive behavioral therapy delivered through a digital platform, consisting of structured weekly sessions over 10 weeks.
Active Comparator: Traditional CBT
Participants in this group will receive standard psychiatric care, including routine clinical monitoring and treatment as determined by their treating clinician, without access to the AI-guided CBT intervention.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depressive symptom severity
Time Frame: Baseline, week 5, and week 10
Change in depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). Higher scores indicate greater depressive symptom severity.
Baseline, week 5, and week 10
Change in anxiety symptom severity
Time Frame: Baseline, week 5, and week 10
Change in anxiety symptoms measured by the Generalized Anxiety Disorder-7 scale (GAD-7). Higher scores indicate greater anxiety symptom severity.
Baseline, week 5, and week 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in perceived stress
Time Frame: Baseline, week 5, and week 10
Change in perceived stress measured by the Perceived Stress Scale (PSS).
Baseline, week 5, and week 10
Change in perceived social support
Time Frame: Baseline and week 10
Change in perceived social support measured by the Multidimensional Scale of Perceived Social Support (MSPSS).
Baseline and week 10
Digital therapeutic alliance
Time Frame: Week 10
Therapeutic alliance measured using the Digital Working Alliance Inventory (D-WAI).
Week 10
Clinical global improvement
Time Frame: Week 5, week 10
Overall clinical improvement measured using the Clinical Global Impression - Improvement scale (CGI-I).
Week 5, week 10
Clinical severity of illness
Time Frame: Baseline, week 5, week 10
Severity of illness measured using the Clinical Global Impression - Severity scale (CGI-S).
Baseline, week 5, week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aleksandra Stojanovic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2026

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

June 10, 2026

Study Registration Dates

First Submitted

May 1, 2026

First Submitted That Met QC Criteria

May 1, 2026

First Posted (Actual)

May 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI-CBT-UKCNIS-2026 (Other Identifier: University Clinical Center Niš, Center for Mental Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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