NCT07500714

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jun 2025Jul 2027

Study Start

First participant enrolled

June 1, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 20, 2026

Last Update Submit

March 25, 2026

Conditions

Depression - Major Depressive Disorder

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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.

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

  • 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.

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

  • 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

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

Secondary Outcomes (8)

  • Psychological well-being

    Weeks 0, 4

  • Resilience Scale

    Weeks 0, 4

  • Potential traumatic experiences

    Weeks 0, 4

  • Nutrition Assessment

    Weeks 0, 4

  • Peripheral Neuropathy Symptom Assessment

    Weeks 0, 4

  • +3 more secondary outcomes

Study Arms (2)

GPT-powered iCBT

EXPERIMENTAL
Behavioral: Internet Cognitive-Behavioral Therapy

Sham

SHAM COMPARATOR
Behavioral: Sham treatment

Interventions

Internet Cognitive-Behavioral TherapyBEHAVIORAL

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

Also known as: iCBT
GPT-powered iCBT
Sham treatmentBEHAVIORAL

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

Sham

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1) Aged 18-75 years
  • Diagnosis of major depressive disorder disorder (Based on Diagnostic Statistical Manual 5)
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mind Body Interface Research Center (MBI Lab & Care)

Taichung, Taichung, 404, Taiwan

RECRUITING

Central Study Contacts

Kuan-Pin Su, MD, PhD.

CONTACT

04-22361230cobol@cmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 20, 2026

First Posted

March 30, 2026

Study Start

June 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)