Depression - Major Depressive DisorderNCT07500714
Integrating Digital Phenotypes and AI-Driven Cognitive-Behavioral Therapy: Advancing Precision Medicine in Depression Through Digital Medicine
A study testing Internet Cognitive-Behavioral Therapy in people with Depression - Major Depressive Disorder, run by National Science and Technology Council, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- Internet Cognitive-Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Mind Body Interface Research Center (MBI Lab & Care)
Taichung, Taichung, 404
Kuan-Pin Su, MD, PhD, +886 (04) 2205-2121 ext. 14128, cobol@cmu.edu.tw
About this study
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.
- Conditions
- Depression - Major Depressive Disorder
- Being tested
- Internet Cognitive-Behavioral Therapy, Sham treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet Cognitive-Behavioral TherapyBehavioural
Also called iCBT
GPT-powered iCBT the participants will receive 8 sessions (30 minutes per session)
Sham treatmentBehavioural
Sham (relaxation/supportive interaction) treatment at Day 2, 5, 9, 12, 16, 19, 23, 27.
| Study group | Role | What they receive |
|---|---|---|
| GPT-powered iCBT | Experimental | Not described Receives: Behavioral: Internet Cognitive-Behavioral Therapy |
| Sham | Sham comparator | Not described Receives: Behavioral: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24
Secondary outcomes (8)
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.
Measured: Weeks 0, 4
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.
Measured: Weeks 0, 4
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.
Measured: Weeks 0, 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.
Measured: Weeks 0, 4
Peripheral Neuropathy Symptom Assessment
Peripheral Neuropathy Symptom is measured by the self-reported Neurotoxicity Rating Scale (NTRS)
Measured: Weeks 0, 4
Physical Activity Level
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"
Measured: Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24
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., <20 ms) are often used as a cut-off for high physiological stress or poor recovery.
Measured: Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24
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.
Measured: Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Science and Technology Council, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kuan-Pin, National Science and Technology Council, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500714
- Sponsor's protocol ID
- TMANH113-REC027
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Digital Phenotypes and AI-Driven Cognitive-Behavioral Therapy: Advancing Precision Medicine in Depression Through Digital Medicine
- ClinicalTrials.gov ID
- NCT07500714
- Acronym / sponsor ID
- TMANH113-REC027
- Conditions
- Depression - Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Science and Technology Council, TaiwanOther government
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GPT-powered iCBT | Experimental | Behavioral: Internet Cognitive-Behavioral Therapy |
| Sham | Sham comparator | Behavioral: Sham treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet Cognitive-Behavioral TherapyAlso: iCBTGPT-powered iCBT the participants will receive 8 sessions (30 minutes per session) | Behavioural | GPT-powered iCBT |
| Sham treatmentSham (relaxation/supportive interaction) treatment at Day 2, 5, 9, 12, 16, 19, 23, 27. | Behavioural | Sham |
Primary outcome
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.
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.
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.
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
8 secondary outcomes
Psychological well-being
Time frame: Weeks 0, 4
Resilience Scale
Time frame: Weeks 0, 4
Potential traumatic experiences
Time frame: Weeks 0, 4
Nutrition Assessment
Time frame: Weeks 0, 4
Peripheral Neuropathy Symptom Assessment
Time frame: Weeks 0, 4
Physical Activity Level
Time frame: Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24
Heart Rate Variability (HRV)
Time frame: Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24
Sleep Patterns (Sleep Score)
Time frame: Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet Cognitive-Behavioral Therapy in people with Depression - Major Depressive Disorder, run by National Science and Technology Council, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kuan-Pin Su, MD, PhD. (04-22361230, cobol@cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Severity (time frame: Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.