Depression - Major Depressive Disorder
Conditions
Brief summary
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.
Interventions
BEHAVIORALInternet Cognitive-Behavioral Therapy
GPT-powered iCBT the participants will receive 8 sessions (30 minutes per session)
BEHAVIORALSham treatment
Sham (relaxation/supportive interaction) treatment at Day 2, 5, 9, 12, 16, 19, 23, 27.
Sponsors
National Science and Technology Council, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Severity | 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. |
| Stress Level | 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. |
| Quality of Life Assessment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychological well-being | 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. |
| Resilience Scale | 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. |
| Potential traumatic experiences | 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. |
| Nutrition Assessment | 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. |
| Peripheral Neuropathy Symptom Assessment | Weeks 0, 4 | Peripheral Neuropathy Symptom is measured by the self-reported Neurotoxicity Rating Scale (NTRS) |
| Physical Activity Level | 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" |
| Heart Rate Variability (HRV) | 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. |
| Sleep Patterns (Sleep Score) | 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. |
Countries
Taiwan
Contacts
CONTACTKuan-Pin Su, MD, PhD.
Outcome results
None listed