AI-Guided CBT for Depression and Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAleksandra Stojanovic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
AI-Guided Cognitive Behavioral Therapy
BehavioralAI-guided cognitive behavioral therapy delivered through a digital platform, consisting of structured weekly sessions over 10 weeks.
Cognitive Behavioral Therapy (CBT)
BehavioralCognitive behavioral therapy delivered by a trained therapist in a standard clinical format, consisting of structured weekly sessions over a 10-week period.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: AI-Guided CBTExperimental treatment 1 intervention
Group B: Traditional CBTActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, week 5, and week 102
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.
Time frame
Baseline, week 5, and week 10Secondary outcomes
1
Change in perceived stress
Change in perceived stress measured by the Perceived Stress Scale (PSS).
Time frame
Baseline, week 5, and week 102
Change in perceived social support
Change in perceived social support measured by the Multidimensional Scale of Perceived Social Support (MSPSS).
Time frame
Baseline and week 103
Digital therapeutic alliance
Therapeutic alliance measured using the Digital Working Alliance Inventory (D-WAI).
Time frame
Week 104
Clinical global improvement
Overall clinical improvement measured using the Clinical Global Impression - Improvement scale (CGI-I).
Time frame
Week 5, week 10Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Aleksandra Stojanovic
Lead sponsor
Clinical Center Niš
Sponsor institution
Source ClinicalTrials.gov