Depression - Major Depressive DisorderAI-CBT-DANCT07576686
AI-Guided CBT for Depression and Anxiety
A study testing AI-Guided Cognitive Behavioral Therapy and Cognitive Behavioral Therapy (CBT) in people with Depression - Major Depressive Disorder and Anxiety Disorders, run by Aleksandra Stojanovic at 1 site in Serbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression - Major Depressive Disorder, Anxiety Disorders
- What is being tested?
- AI-Guided Cognitive Behavioral Therapy and Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSerbia
- Study dates
- 7 Jan 2026to 10 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Serbia1 site, 1 recruiting
- Recruiting
University Clinical Center Niš
Niš, 18000
Aleksandra Stojanović, MD, PHD candidate, +381642293541, drakiwatson@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- AI-Guided Cognitive Behavioral Therapy, Cognitive Behavioral Therapy (CBT)
- Keywords
- AI-guided psychotherapy, Cognitive Behavioral Therapy, Digital Mental Health, Depression, Anxiety, Artificial Intelligence, Digital Therapeutic Alliance, eHealth, Internet-based CBT
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Guided Cognitive Behavioral TherapyBehavioural
AI-guided cognitive behavioral therapy delivered through a digital platform, consisting of structured weekly sessions over 10 weeks.
Cognitive Behavioral Therapy (CBT)Behavioural
Cognitive behavioral therapy delivered by a trained therapist in a standard clinical format, consisting of structured weekly sessions over a 10-week period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, week 5, and week 10
Secondary outcomes (5)
Change in perceived stress
Change in perceived stress measured by the Perceived Stress Scale (PSS).
Measured: 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).
Measured: Baseline and week 10
Digital therapeutic alliance
Therapeutic alliance measured using the Digital Working Alliance Inventory (D-WAI).
Measured: Week 10
Clinical global improvement
Overall clinical improvement measured using the Clinical Global Impression - Improvement scale (CGI-I).
Measured: Week 5, week 10
Clinical severity of illness
Severity of illness measured using the Clinical Global Impression - Severity scale (CGI-S).
Measured: Baseline, week 5, week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start7 Jan 2026
- Primary completion15 May 2026 (estimated)
- Study completion10 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aleksandra Stojanovic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aleksandra Stojanovic, Clinical Center Niš
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576686
- Sponsor's protocol ID
- AI-CBT-UKCNIS-2026
- Other IDs
- AI-CBT-UKCNIS-2026
- Acronym
- AI-CBT-DA
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Significance of Artificial Intelligence-Guided Psychotherapy of Depression and Anxiety Disorders
- ClinicalTrials.gov ID
- NCT07576686
- Acronym / sponsor ID
- AI-CBT-DA / AI-CBT-UKCNIS-2026
- Keywords
- AI-guided psychotherapy, Cognitive Behavioral Therapy, Digital Mental Health, Depression, Anxiety, Artificial Intelligence, Digital Therapeutic Alliance, eHealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Aleksandra StojanovicUniversity, hospital or other
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 10 Jun 2026 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| AI-Guided CBT | Experimental | Behavioral: AI-Guided Cognitive Behavioral TherapyParticipants 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. |
| Traditional CBT | Active comparator | Behavioral: Cognitive Behavioral Therapy (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Guided Cognitive Behavioral TherapyAI-guided cognitive behavioral therapy delivered through a digital platform, consisting of structured weekly sessions over 10 weeks. | Behavioural | AI-Guided CBT |
| 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. | Behavioural | Traditional CBT |
Primary outcome
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.
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.
5 secondary outcomes
Change in perceived stress
Time frame: Baseline, week 5, and week 10
Change in perceived social support
Time frame: Baseline and week 10
Digital therapeutic alliance
Time frame: Week 10
Clinical global improvement
Time frame: Week 5, week 10
Clinical severity of illness
Time frame: Baseline, week 5, week 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Guided Cognitive Behavioral Therapy and Cognitive Behavioral Therapy (CBT) in people with Depression - Major Depressive Disorder and Anxiety Disorders, run by Aleksandra Stojanovic at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aleksandra Stojanovic, MD, PhD Candidate (+381642293541, drakiwatson@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptom severity (time frame: Baseline, week 5, and week 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.