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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNational Science and Technology Council, Taiwan

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

(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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Internet Cognitive-Behavioral Therapy

    Behavioral

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

  • Sham treatment

    Behavioral

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: GPT-powered iCBTExperimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24
2

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.

Time frame
Weeks 0, 1, 2, 4, 8,12, 16, 20, 24
3

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.

Time frame
Weeks 0, 1, 2, 4, 8,12, 16, 20, 24
4

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

Time frame
Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24

Secondary outcomes

1

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.

Time frame
Weeks 0, 4
2

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.

Time frame
Weeks 0, 4
3

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.

Time frame
Weeks 0, 4
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.

Time frame
Weeks 0, 4

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.