Clinical trial Recruiting at 1 site Interventional Ages 18 to 75

Using smartphone and wearable data plus AI-guided online CBT to personalize depression care

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

Run by National Science and Technology Council, Taiwan · NCT07500714 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment100 (estimated)
SponsorNational Science and Technology Council, Taiwan
Government
Locations1 site (Taichung, Taichung)
StatusRecruiting
StartedJune 1, 2025
Main results expectedJune 2027
Study endsJuly 2027
Registry record updatedMarch 30, 2026
Trial IDNCT07500714 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Mind Body Interface Research Center (MBI Lab & Care)
    Taichung, Taichung, Taiwan
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.