AI-Guided CBT for Depression and Anxiety (AI-CBT-DA)
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.
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Aleksandra Stojanović, MD, PHD candidate
- Número de telefone: +381642293541
- E-mail: drakiwatson@gmail.com
Locais de estudo
-
-
-
Niš, Sérvia, 18000
- Recrutamento
- University Clinical Center Nis
-
Contato:
- Aleksandra Stojanović, MD, PHD candidate
- Número de telefone: +381642293541
- E-mail: drakiwatson@gmail.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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-
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: AI-Guided CBT
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.
|
AI-guided cognitive behavioral therapy delivered through a digital platform, consisting of structured weekly sessions over 10 weeks.
|
|
Comparador Ativo: Traditional 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.
|
Cognitive behavioral therapy delivered by a trained therapist in a standard clinical format, consisting of structured weekly sessions over a 10-week period.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in depressive symptom severity
Prazo: 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.
|
Baseline, week 5, and week 10
|
|
Change in anxiety symptom severity
Prazo: 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.
|
Baseline, week 5, and week 10
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in perceived stress
Prazo: Baseline, week 5, and week 10
|
Change in perceived stress measured by the Perceived Stress Scale (PSS).
|
Baseline, week 5, and week 10
|
|
Change in perceived social support
Prazo: Baseline and week 10
|
Change in perceived social support measured by the Multidimensional Scale of Perceived Social Support (MSPSS).
|
Baseline and week 10
|
|
Digital therapeutic alliance
Prazo: Week 10
|
Therapeutic alliance measured using the Digital Working Alliance Inventory (D-WAI).
|
Week 10
|
|
Clinical global improvement
Prazo: Week 5, week 10
|
Overall clinical improvement measured using the Clinical Global Impression - Improvement scale (CGI-I).
|
Week 5, week 10
|
|
Clinical severity of illness
Prazo: Baseline, week 5, week 10
|
Severity of illness measured using the Clinical Global Impression - Severity scale (CGI-S).
|
Baseline, week 5, week 10
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- AI-CBT-UKCNIS-2026 (Outro identificador: University Clinical Center Niš, Center for Mental Health)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .