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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GPT-powered iCBT | Experimental |
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| Sham | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet Cognitive-Behavioral Therapy | Behavioral | GPT-powered iCBT the participants will receive 8 sessions (30 minutes per session) |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kuan-Pin Su, MD, PhD. | Contact | 04-22361230 | cobol@cmu.edu.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mind Body Interface Research Center (MBI Lab & Care) | Recruiting | Taichung | Taichung | 404 | Taiwan |
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| Sham treatment | Behavioral | Sham (relaxation/supportive interaction) treatment at Day 2, 5, 9, 12, 16, 19, 23, 27. |
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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 |