AI-Guided CBT for Depression and Anxiety

NCT07576686 | Recruiting

• 1 other identifier: AI-CBT-UKCNIS-2026
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression - Major Depressive Disorder; Anxiety Disorders

Keywords

AI-guided psychotherapy; Cognitive Behavioral Therapy; Digital Mental Health; Depression; Anxiety; Artificial Intelligence; Digital Therapeutic Alliance; eHealth; Internet-based CBT

Outcome Measures

Primary Outcomes (2)

• Change in depressive symptom severity

  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

  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 Outcomes (5)

• Change in perceived stress

  Baseline, week 5, and week 10

• Change in perceived social support

  Baseline and week 10

• Digital therapeutic alliance

  Week 10

• Clinical global improvement

  Week 5, week 10

• Clinical severity of illness

  Baseline, week 5, week 10

Study Arms (2)

AI-Guided CBT

EXPERIMENTAL

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

Traditional CBT

ACTIVE COMPARATOR

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)

Interventions

AI-Guided Cognitive Behavioral Therapy BEHAVIORAL

AI-guided cognitive behavioral therapy delivered through a digital platform, consisting of structured weekly sessions over 10 weeks.

AI-Guided CBT

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

Cognitive behavioral therapy delivered by a trained therapist in a standard clinical format, consisting of structured weekly sessions over a 10-week period.

Traditional CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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-

Sponsors & Collaborators

• Aleksandra Stojanovic: lead

Study Sites (1)

University Clinical Center Niš

Niš, 18000, Serbia

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Aleksandra Stojanovic, MD, PhD Candidate

CONTACT

+381642293541; drakiwatson@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Due to the nature of the intervention, neither participants nor care providers are blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Model Details: Participants will be assigned to one of two parallel groups: an experimental group receiving AI-guided cognitive behavioral therapy and a control group receiving standard psychiatric care. The intervention will last 10 weeks, with weekly sessions delivered through a digital platform under clinical supervision.

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 8, 2026
• Study Start: January 7, 2026
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): June 10, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)