Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07500714

Integrating Digital Phenotypes and AI-Driven Cognitive-Behavioral Therapy: Advancing Precision Medicine in Depression Through Digital Medicine

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mind Body Interface Research Center (MBI Lab & Care)

Taichung, 404, Taiwan

Location status: Recruiting

Location contact

Kuan-Pin Su, MD, PhD

CONTACT

[email protected]

+886 (04) 2205-2121 ext. 14128

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Internet Cognitive-Behavioral Therapy

Behavioral

GPT-powered iCBT the participants will receive 8 sessions (30 minutes per session)

Other names: iCBT

Sham Treatment

Behavioral

Sham (relaxation/supportive interaction) treatment at Day 2, 5, 9, 12, 16, 19, 23, 27.

Primary outcomes

  1. Depression Severity

    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.

  2. Depression Severity

    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.

  3. Stress Level

    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.

  4. Quality of Life Assessment

    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

Secondary outcomes

  1. Psychological well-being

    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.

  2. Resilience Scale

    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.

  3. Potential traumatic experiences

    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.

  4. Nutrition Assessment

    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.

  5. Peripheral Neuropathy Symptom Assessment

    Time frame: Weeks 0, 4

    Peripheral Neuropathy Symptom is measured by the self-reported Neurotoxicity Rating Scale (NTRS)

  6. Physical Activity Level

    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"

  7. Heart Rate Variability (HRV)

    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.

  8. Sleep Patterns (Sleep Score)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kuan-Pin Su, MD, PhD.

CONTACT

[email protected]

04-22361230

Sponsors and collaborators

Lead sponsor

National Science and Technology Council, Taiwan

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

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.