[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631441":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":48,"studyPopulation":48,"armGroups":59,"interventions":70,"overallOfficials":48,"centralContacts":82,"locations":88,"responsibleParty":107,"collaborators":48,"id":111,"slug":48,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":48,"eligibilityCriteria":115,"healthyVolunteers":116,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":48,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":48,"overallStatus":91,"whyStopped":48,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"National Science and Technology Council, Taiwan","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":48},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"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",{"measure":10,"description":14,"timeFrame":15},"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",{"measure":17,"description":18,"timeFrame":15},"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.",{"measure":20,"description":21,"timeFrame":12},"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",[23,27,30,33,36,39,42,45],{"measure":24,"description":25,"timeFrame":26},"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",{"measure":28,"description":29,"timeFrame":26},"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.",{"measure":31,"description":32,"timeFrame":26},"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.",{"measure":34,"description":35,"timeFrame":26},"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.",{"measure":37,"description":38,"timeFrame":26},"Peripheral Neuropathy Symptom Assessment","Peripheral Neuropathy Symptom is measured by the self-reported Neurotoxicity Rating Scale (NTRS)",{"measure":40,"description":41,"timeFrame":12},"Physical Activity Level","Continuous monitoring of daily physical activity via the Garmin Vívoactive 5 wearable device. Unit of Measure: number of steps per day. \\\u003C5,000 steps\u002Fday is often defined as \"sedentary,\" while \\>7,500 steps\u002Fday is \"physically active\"",{"measure":43,"description":44,"timeFrame":12},"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., \\\u003C20 ms) are often used as a cut-off for high physiological stress or poor recovery.",{"measure":46,"description":47,"timeFrame":12},"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.",null,{"allocation":50,"interventionModel":51,"interventionModelDescription":48,"primaryPurpose":52,"observationalModel":48,"timePerspective":48,"maskingInfo":53},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":54,"maskingDescription":48,"whoMasked":55},"TRIPLE",[56,57,58],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR",[60,65],{"label":61,"type":62,"description":48,"interventionNames":63},"GPT-powered iCBT","EXPERIMENTAL",[64],"Behavioral: Internet Cognitive-Behavioral Therapy",{"label":66,"type":67,"description":48,"interventionNames":68},"Sham","SHAM_COMPARATOR",[69],"Behavioral: Sham treatment",[71,78],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":76},"BEHAVIORAL","Internet Cognitive-Behavioral Therapy","GPT-powered iCBT the participants will receive 8 sessions (30 minutes per session)",[61],[77],"iCBT",{"type":72,"name":79,"description":80,"armGroupLabels":81,"otherNames":48},"Sham treatment","Sham (relaxation\u002Fsupportive interaction) treatment at Day 2, 5, 9, 12, 16, 19, 23, 27.",[66],[83],{"name":84,"role":85,"phone":86,"phoneExt":48,"email":87},"Kuan-Pin Su, MD, PhD.","CONTACT","04-22361230","cobol@cmu.edu.tw",[89],{"facility":90,"status":91,"city":92,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"Mind Body Interface Research Center (MBI Lab & Care)","RECRUITING","Taichung","404","Taiwan","TW",{"type":97,"coordinates":98},"Point",[99,100],120.6839,24.1469,{"lat":100,"lon":99},[103],{"name":104,"role":85,"phone":105,"phoneExt":106,"email":87},"Kuan-Pin Su, MD, PhD","+886 (04) 2205-2121","14128",{"type":108,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":48,"oldOrganization":48},"PRINCIPAL_INVESTIGATOR","Kuan-Pin","Professor","100631441",false,"NCT07500714","Integrating Digital Phenotypes and AI-Driven Cognitive-Behavioral Therapy: Advancing Precision Medicine in Depression Through Digital Medicine","Inclusion Criteria:\n\n* (1) Aged 18-75 years\n* Diagnosis of major depressive disorder disorder (Based on Diagnostic Statistical Manual 5)\n* 21-item Hamilton Depression Scale (HAMD21)\\>17\n* 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\n* Full competency to understand the study details and provide written informed consent\n\nExclusion Criteria:\n\n* 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)\n* Psychotic disorders, bipolar affective disorder, a substance use disorders in the past 6 months, active suicidal or homicidal ideation (per assessment or HAMD\\>3)\n* Unstable or active medical illness.",true,"ALL","18 Years","75 Years",{"count":121,"type":122},100,"ESTIMATED","INTERVENTIONAL",[125],"NA","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.",[128],"Depression - Major Depressive Disorder","2026-03-25",{"date":131,"type":132},"2026-03-30","ACTUAL",{"date":134,"type":132},"2025-06-01",{"date":136,"type":122},"2027-07",{"name":5,"class":6},1]