Using smartphone and wearable data plus AI-guided online CBT to personalize depression care
Integrating Digital Phenotypes and AI-Driven Cognitive-Behavioral Therapy: Advancing Precision Medicine in Depression Through Digital Medicine
This project will try combining real-time smartphone and wearable monitoring with AI-driven online cognitive-behavioral therapy to personalize treatment for adults (18–75) with major depressive disorder in Taiwan.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | National Science and Technology Council, Taiwan Government |
| Locations | 1 site (Taichung, Taichung) |
| Trial ID | NCT07500714 on ClinicalTrials.gov |
What this trial studies
Participants will provide passive and active digital phenotyping data (behavioral and physiological signals) via smartphones and wearables while receiving either AI-driven internet cognitive-behavioral therapy or a sham internet intervention. The platform will link dynamic, real-time markers to symptom changes to refine diagnostic classifications and guide individualized therapeutic recommendations. Eligible participants are adults with DSM-5 major depressive disorder and a HAMD-21 score above 17 who have had no recent changes in psychiatric treatment. The study is conducted at the Mind Body Interface Research Center in Taichung and aims to integrate data-driven diagnostics with personalized digital treatment pathways.
Who should consider this trial
Good fit: Adults aged 18–75 with DSM-5 major depressive disorder, HAMD-21 > 17, stable psychiatric treatment for at least four weeks, capacity to consent, and ability to use a smartphone and attend the Taichung site are ideal candidates.
Not a fit: Patients with marked to extreme illness severity (high CGI-S), psychotic or bipolar disorders, recent substance use disorder, active suicidal ideation, or unstable medical illness are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the approach could speed up matching patients to more effective, personalized treatments and reduce the need for frequent in-person visits.
How similar studies have performed: Previous work has shown promising results for internet CBT and for digital phenotyping separately, but combining real-time digital markers with AI-driven individualized CBT is relatively novel and less well tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Taichung, Taichung
- Mind Body Interface Research Center (MBI Lab & Care) — Taichung, Taichung, Taiwan (Recruiting)
Study contacts
- Study coordinator: Kuan-Pin Su, MD, PhD.
- Email: cobol@cmu.edu.tw
- Phone: 04-22361230
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.