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Recruiting NCT07500714

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

No phase Interventional Depression - Major Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Internet Cognitive-Behavioral Therapy, Sham treatment.
Who it may be relevant to
Registry conditions: Depression - Major Depressive Disorder. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral Internet Cognitive-Behavioral Therapy
    GPT-powered iCBT the participants will receive 8 sessions (30 minutes per session)
  • Behavioral Sham treatment
    Sham (relaxation/supportive interaction) treatment at Day 2, 5, 9, 12, 16, 19, 23, 27.

Primary outcome measures

  • Depression Severity [Time frame: Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24]
  • Depression Severity [Time frame: Weeks 0, 1, 2, 4, 8,12, 16, 20, 24]
  • Stress Level [Time frame: Weeks 0, 1, 2, 4, 8,12, 16, 20, 24]
  • Quality of Life Assessment [Time frame: Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24]
Secondary outcome measures (8)
  • Psychological well-being [Time frame: Weeks 0, 4]
  • Resilience Scale [Time frame: Weeks 0, 4]
  • Potential traumatic experiences [Time frame: Weeks 0, 4]
  • Nutrition Assessment [Time frame: Weeks 0, 4]
  • Peripheral Neuropathy Symptom Assessment [Time frame: Weeks 0, 4]
  • Physical Activity Level [Time frame: Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24]
  • Heart Rate Variability (HRV) [Time frame: Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24]
  • Sleep Patterns (Sleep Score) [Time frame: Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24]

Eligibility criteria

Inclusion criteria

  • (1) Aged 18-75 years
  • Diagnosis of major depressive disorder disorder (Based on Diagnostic Statistical Manual 5)
  • 21-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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Supportive care

Study locations

Taiwan · 1 center
  • Mind Body Interface Research Center (MBI Lab & Care) — Taichung

Identifiers

NCT: NCT07500714 · TMANH113-REC027

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗