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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression - Major Depressive Disorder
• Intervention / Treatment: Behavioral: Internet Cognitive-Behavioral Therapy; Behavioral: Sham treatment

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kuan-Pin Su, MD, PhD.; Phone Number: 04-22361230; Email: cobol@cmu.edu.tw

Study Locations

• Taiwan
  • Taichung
    • Taichung, Taichung, Taiwan, 404
      • Recruiting
      • Mind Body Interface Research Center (MBI Lab & Care)
      • Contact: Kuan-Pin Su, MD, PhD; Phone Number: 14128 +886 (04) 2205-2121; Email: cobol@cmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham	Behavioral: Sham treatment; Sham (relaxation/supportive interaction) treatment at Day 2, 5, 9, 12, 16, 19, 23, 27.
Experimental: GPT-powered iCBT	Behavioral: Internet Cognitive-Behavioral Therapy; GPT-powered iCBT the participants will receive 8 sessions (30 minutes per session); Other Names: iCBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression Severity	Depression severity is measured by the 21-item Hamilton Rating Scale for Depression (HAM-D). A higher score indicates greater severity, a score of ≥18 indicates moderate to severe depression.	Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24
Depression Severity	Depression severity is measured by the 9-item Patient Health Questionnaire (PHQ-9). A score of ≥10 is the most common threshold used to identify individuals likely to have major depressive disorder.	Weeks 0, 1, 2, 4, 8,12, 16, 20, 24
Stress Level	Stress level is measured by the Life Events Perceived Stress (LEPS). A total score of ≥27 is widely recognized as the cut-off for high perceived stress.	Weeks 0, 1, 2, 4, 8,12, 16, 20, 24
Quality of Life Assessment	Quality of Life Assessment is measured by the EuroQol questionnaire (EQ-5D). The Index Score (usually 0 to 1), where 1.0 is full health, index scores below 0.6 are often characterized as representing low quality of life	Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological well-being	Psychological well-being is measured by the Brief Live Experience Questionnaire (BLEQ12). Score Range: 0-36; higher scores indicate greater general psychological well-being.	Weeks 0, 4
Resilience Scale	Resilience is measured by the Resilience Scale for Adults (RSA). The scale uses a 7-point semantic differential scale (e.g., ranging from "Difficult to accomplish" to "Possible to accomplish"), with a total score range of: 33 to 231.	Weeks 0, 4
Potential traumatic experiences	Resilience is measured by the Adverse Childhood Experiences-International Questionnaire. ACE Score (0-13): One point is given for each category of trauma experienced. The "Cut-off": A score of ≥4 is the widely recognized threshold where the risk of chronic disease, depression, and social problems increases significantly.	Weeks 0, 4
Nutrition Assessment	Nutrition Assessment is measured by the Taiwanese version of the Mini Nutrition Assessment (MNA). The MNA Long Form consists of 18 items with a maximum score of 30 points, where a score of 24 to 30 points indicates normal nutritional status, 17 to 23.5 points indicates a risk of malnutrition, and less than 17 points signifies that the individual is malnourished.	Weeks 0, 4
Peripheral Neuropathy Symptom Assessment	Peripheral Neuropathy Symptom is measured by the self-reported Neurotoxicity Rating Scale (NTRS)	Weeks 0, 4
Physical Activity Level	Continuous monitoring of daily physical activity via the Garmin Vívoactive 5 wearable device. Unit of Measure: number of steps per day. <5,000 steps/day is often defined as "sedentary," while >7,500 steps/day is "physically active"	Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24
Heart Rate Variability (HRV)	Continuous monitoring of the variation in time between consecutive heartbeats measured during rest using the Garmin Vívoactive 5. Unit of Measure: Root mean square of successive differences (RMSSD) in milliseconds (ms). Absolute Values (RMSSD): For healthy adults (ages 38-42), a normal range is typically 19-48 ms. Scores significantly below this (e.g., <20 ms) are often used as a cut-off for high physiological stress or poor recovery.	Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24
Sleep Patterns (Sleep Score)	Continuous monitoring is measured using the Garmin Vívoactive 5. Garmin's internal "Sleep Score" (0-100) uses 60 as the threshold for "Poor" sleep. A higher score shows better results.	Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24

Collaborators and Investigators

• Sponsor: National Science and Technology Council, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: TMANH113-REC027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No