An interventional study of Internet Cognitive-Behavioral Therapy and Sham treatment in Depression - Major Depressive Disorder, sponsored by National Science and Technology Council, Taiwan. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by National Science and Technology Council, Taiwan · Not applicable, Interventional, and Supportive care
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.
National Science and Technology Council, Taiwan is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Internet Cognitive-Behavioral Therapy
Behavioral: Sham treatment
GPT-powered iCBT the participants will receive 8 sessions (30 minutes per session)
Also known as: iCBT
Sham (relaxation/supportive interaction) treatment at Day 2, 5, 9, 12, 16, 19, 23, 27.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Weeks 0, 4
Peripheral Neuropathy Symptom Assessment
Peripheral Neuropathy Symptom is measured by the self-reported Neurotoxicity Rating Scale (NTRS)
Time frame: 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"
Time frame: 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.
Time frame: 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.
Time frame: Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24
Plan to share: No
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National Science and Technology Council, Taiwan