Mind Body Interface Research Center (MBI Lab & Care)
Taichung, 404, Taiwan
Location status: Recruiting
NCT Number: NCT07500714
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Taichung, 404, Taiwan
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
GPT-powered iCBT the participants will receive 8 sessions (30 minutes per session)
Other names: iCBT
Sham (relaxation/supportive interaction) treatment at Day 2, 5, 9, 12, 16, 19, 23, 27.
Time frame: Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24
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 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 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 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, 4
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 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
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 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 is measured by the self-reported Neurotoxicity Rating Scale (NTRS)
Time frame: Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24
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
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
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.
Contact information is provided by the study sponsor or research team.
National Science and Technology Council, Taiwan
Other Gov
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07188623
Behavior, Behavioral Activation Treatment
Stanford, California, United States
View Trial DetailsNCT07050355
Behavior, Brain Diseases
Durham, North Carolina, United States
View Trial DetailsNCT07250893
Behavior, Behavioral Symptoms
Hamilton, Ontario, Canada
View Trial DetailsNCT07611773
Depression - Major Depressive Disorder, Depressive Disorder
Valencia, Spain
View Trial Details