Anxiety Disorders, Depression - Major Depressive Disorder
Conditions
Keywords
AI-guided psychotherapy, Cognitive Behavioral Therapy, Digital Mental Health, Depression, Anxiety, Artificial Intelligence, Digital Therapeutic Alliance, eHealth, Internet-based CBT
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.
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.
Interventions
BEHAVIORALAI-Guided Cognitive Behavioral Therapy
AI-guided cognitive behavioral therapy delivered through a digital platform, consisting of structured weekly sessions over 10 weeks.
BEHAVIORALCognitive 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.
Sponsors
Aleksandra Stojanovic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study. Due to the nature of the intervention, neither participants nor care providers are blinded to treatment allocation.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in depressive symptom severity | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in perceived stress | Baseline, week 5, and week 10 | Change in perceived stress measured by the Perceived Stress Scale (PSS). |
| Change in perceived social support | Baseline and week 10 | Change in perceived social support measured by the Multidimensional Scale of Perceived Social Support (MSPSS). |
| Digital therapeutic alliance | Week 10 | Therapeutic alliance measured using the Digital Working Alliance Inventory (D-WAI). |
| Clinical global improvement | Week 5, week 10 | Overall clinical improvement measured using the Clinical Global Impression - Improvement scale (CGI-I). |
| Clinical severity of illness | Baseline, week 5, week 10 | Severity of illness measured using the Clinical Global Impression - Severity scale (CGI-S). |
Countries
Serbia
Contacts
CONTACTAleksandra Stojanovic, MD, PhD Candidate
Outcome results
None listed