RecruitingNot ApplicableNCT07500714

Integrating Digital Phenotypes and AI-Driven Cognitive-Behavioral Therapy: Advancing Precision Medicine in Depression Through Digital Medicine


Sponsor

National Science and Technology Council, Taiwan

Enrollment

100 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This project aims to integrate digital phenotyping and AI-driven iCBT into a comprehensive platform for MDD diagnosis and treatment in Taiwan. The study will explore dynamic, real-time behavioral and physiological markers to refine diagnostic classifications and optimize personalized therapeutic strategies.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • (1) Aged 18-75 years
  • Diagnosis of major depressive disorder disorder (Based on Diagnostic Statistical Manual 5)
  • item Hamilton Depression Scale (HAMD21)\>17
  • No changes in current psychiatric treatment for depression (e.g., no treatment, antidepressant medication, psychotherapy, or non-invasive brain stimulation) within the past four weeks, and
  • Full competency to understand the study details and provide written informed consent

Exclusion Criteria3

  • Scores of 5 ( Markedly ill), 6,(Severely ill), and 7 (Among the most extremely ill) according to the Clinical Global Impression Scale-Severity (CGI-S)
  • Psychotic disorders, bipolar affective disorder, a substance use disorders in the past 6 months, active suicidal or homicidal ideation (per assessment or HAMD\>3)
  • Unstable or active medical illness.

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Interventions

BEHAVIORALInternet Cognitive-Behavioral Therapy

GPT-powered iCBT the participants will receive 8 sessions (30 minutes per session)

BEHAVIORALSham treatment

Sham (relaxation/supportive interaction) treatment at Day 2, 5, 9, 12, 16, 19, 23, 27.


Locations(1)

Mind Body Interface Research Center (MBI Lab & Care)

Taichung, Taichung, Taiwan

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NCT07500714


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