An interventional study of AI-Guided Cognitive Behavioral Therapy and Cognitive Behavioral Therapy (CBT) in Depression - Major Depressive Disorder and Anxiety Disorders, sponsored by Aleksandra Stojanovic. Recruiting at 1 site in Serbia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Aleksandra Stojanovic · Not applicable, Interventional, and Treatment
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.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's planned enrollment of 120 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →This is the only study on the registry with Aleksandra Stojanovic as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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-
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
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)
AI-guided cognitive behavioral therapy delivered through a digital platform, consisting of structured weekly sessions over 10 weeks.
Cognitive behavioral therapy delivered by a trained therapist in a standard clinical format, consisting of structured weekly sessions over a 10-week period.
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 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.
Time frame: Baseline, week 5, and week 10
Change in perceived stress
Change in perceived stress measured by the Perceived Stress Scale (PSS).
Time frame: Baseline, week 5, and week 10
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 10
Digital therapeutic alliance
Therapeutic alliance measured using the Digital Working Alliance Inventory (D-WAI).
Time frame: Week 10
Clinical global improvement
Overall clinical improvement measured using the Clinical Global Impression - Improvement scale (CGI-I).
Time frame: Week 5, week 10
Clinical severity of illness
Severity of illness measured using the Clinical Global Impression - Severity scale (CGI-S).
Time frame: Baseline, week 5, week 10
Plan to share: No
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