DepressionNCT06770075
Brightline: Advancing Mental Health on Campus
An observational study of Depression and Anxiety, run by Nanyang Technological University at 1 site in Singapore.
Trial summary
This observational study will employ a multi-modal observation methodology, integrating data from wearable devices and smartphones to establish comprehensive digital biomarkers for identifying symptoms of mental health conditions in university students. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Stress
- What is being tested?
- Observational
- How many people
- 500 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2025to Mar 2026
- Phase
- Observational
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Undergraduate students
Who may be able to join
- Be aged 18 years or older.
- Be a current full-time undergraduate student.
- Own a smartphone with Wi-Fi, 4G, and Bluetooth capabilities.
- Possess adequate English language proficiency.
- Be able to download the study apps.
- Provide informed consent.
Who cannot join
- Are part-time students.
- Have a current diagnosis of any mental health disorder or a past diagnosis with any bipolar disorder, substance use disorder, or any psychotic disorder.
- Are currently undergoing mental health treatment.
- Lack sufficient English proficiency.
- Report suicidal ideation as indicated by Patient Health Questionnaire (PHQ-9) Item-9, "Thoughts you would be better off dead or of hurting yourself in some way".
- Cannot commit to wearing a wearable device for the six-month monitoring period.
- Receive special education accommodations or support from the university.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Nanyang Technological University
Singapore, 639798
Zhi Wei Tan, PhD, +65 92312575, zhiwei.tan@ntu.edu.sg
Andy WH Khong, PhD
About this study
Official title: Brightline - a Digital Phenotyping Study Toward Advancing Mental Health on Campus
This observational study will employ a multi-modal observation methodology, integrating data from wearable devices and smartphones to establish comprehensive digital biomarkers for identifying symptoms of mental health conditions in university students. The study aims to identify the digital behavioural markers associated with mental health conditions, develop predictive algorithms for mental health states from digital markers, and identify university students at risk for mental health conditions.
Read the detailed description
In this study, participants will be monitored over a six-month period to determine the association between digital behavioural markers and mental health symptoms among university students. Participants will be passively monitored to collect digital phenotyping data (e.g., physical activity, sleep activity, heart rate, physiological patterns, sociability indices, finger taps, ambient light, phone states, etc.), using a wearable device and sensors from the smartphone. Participants will also complete self-report questionnaires at Months 0, 1, 3, and 6, to track changes in mental health symptoms and behavioural data. The collected data will be analysed to examine the longitudinal changes in depression, anxiety, and other mental health issues among university students and explore the feasibility of data collection procedures.
- Conditions
- Depression, Anxiety, Stress, Positive Affect, Negative Affect, Loneliness
- Being tested
- Observational
- Keywords
- university student, mental health, digital phenotyping, digital biomarkers, passive sensing, risk prediction, mental health seeking
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Also called There will be no interventions involved in this study.
Participants will not receive any study intervention. During the six month study period, participants will complete four active assessments at Months 0, 1, 3 and 6, and data from the study-provided wearable (Fitbit Charge 6) and sensors from the participant's smartphone (through the Brightline app) will be collected passively throughout.
| Study group | Role | What they receive |
|---|---|---|
| Undergraduate students | Undergraduate students from Nanyang Technological University Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
A nine-item scale assessing depression severity. A higher total score indicates increased depression severity.
Measured: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)
Secondary outcomes (7)
Generalized Anxiety Disorder-7 (GAD-7)
A seven-item scale assessing anxiety severity. A higher total score indicates increased anxiety severity.
Measured: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)
Perceived Stress Scale 4 (PSS-4)
A four-item scale assessing stress severity. A higher total score indicates increased stress severity.
Measured: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)
International Positive and Negative Affect Schedule - Short Form (I-PANAS-SF)
A ten-item scale divided into two subscales, assessing subjective experiences of positive and negative affect. A higher total score on each subscale indicates increased positive or negative affect.
Measured: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)
University of California Los Angeles, 3-Item Loneliness Scale (UCLA-3)
A three-item scale assessing levels of loneliness. A higher total score indicates increased loneliness.
Measured: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)
University Stress Scale (USS)
A 21-item scale assessing the degree to which university life events are perceived as stressful. A higher score indicates increased perceived stress.
Measured: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)
Mental Help Seeking Attitudes Scale (MHSAS)
A nine-item scale assessing attitudes towards seeking mental health help. A higher score indicates more favorable attitudes towards seeking mental health assistance.
Measured: Baseline (Month 0), End-point (Month 6)
Perceptions of study compliance
Participants will be evaluated on five items assessing the acceptability of the study procedure, specifically related to wearing the wearable device. Additionally, they will be provided a free-text response to details any difficulties or challenges encountered during the study period.
Measured: End-point (Month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanyang Technological University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Singapore
- Responsible party
- Principal investigator, Andy Khong W H, Nanyang Technological University
- Investigators
- Andy WH Khong, PhD, Principal investigator, Nanyang Technological UniversityAndy HY Ho, PhD, EdD, Principal investigator, Nanyang Technological University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770075
- Sponsor's protocol ID
- IRB-2023-894
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ito S, Ang CS, Kampman OP, Rokde K, Buddhika T, Heaukulani C, Tan ZW, Dewanti FA, Au EWM, Huan VS, Morris RJ, Khong AWH, Ho AHY. Harnessing digital phenotyping to advance university student mental health (Brightline) in Singapore: study protocol for a prospective observational study. BMJ Open. 2025 Sep 22;15(9):e103652. doi: 10.1136/bmjopen-2025-103652.
PubMed 40983586
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brightline - a Digital Phenotyping Study Toward Advancing Mental Health on Campus
- ClinicalTrials.gov ID
- NCT06770075
- Acronym / sponsor ID
- IRB-2023-894
- Conditions
- Depression, Anxiety, Stress, Positive Affect, Negative Affect, Loneliness
- Keywords
- university student, mental health, digital phenotyping, digital biomarkers, passive sensing, risk prediction, mental health seeking
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Nanyang Technological UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, Singapore
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 13 Jan 2025 (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 observational study will employ a multi-modal observation methodology, integrating data from wearable devices and smartphones to establish comprehensive digital biomarkers for identifying symptoms of mental health conditions in university students. The study aims to identify the digital behavioural markers associated with mental health conditions, develop predictive algorithms for mental health states from digital markers, and identify university students at risk for mental health conditions.
Detailed description
In this study, participants will be monitored over a six-month period to determine the association between digital behavioural markers and mental health symptoms among university students. Participants will be passively monitored to collect digital phenotyping data (e.g., physical activity, sleep activity, heart rate, physiological patterns, sociability indices, finger taps, ambient light, phone states, etc.), using a wearable device and sensors from the smartphone. Participants will also complete self-report questionnaires at Months 0, 1, 3, and 6, to track changes in mental health symptoms and behavioural data. The collected data will be analysed to examine the longitudinal changes in depression, anxiety, and other mental health issues among university students and explore the feasibility of data collection procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Undergraduate students | – | Other: ObservationalUndergraduate students from Nanyang Technological University |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Undergraduate students
Key inclusion criteria (6 listed)
- Be aged 18 years or older.
- Be a current full-time undergraduate student.
- Own a smartphone with Wi-Fi, 4G, and Bluetooth capabilities.
- Possess adequate English language proficiency.
- Be able to download the study apps.
Key exclusion criteria (7 listed)
- Are part-time students.
- Have a current diagnosis of any mental health disorder or a past diagnosis with any bipolar disorder, substance use disorder, or any psychotic disorder.
- Are currently undergoing mental health treatment.
- Lack sufficient English proficiency.
- Report suicidal ideation as indicated by Patient Health Questionnaire (PHQ-9) Item-9, "Thoughts you would be better off dead or of hurting yourself in some way".
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 |
|---|---|---|
| ObservationalAlso: There will be no interventions involved in this study.Participants will not receive any study intervention. During the six month study period, participants will complete four active assessments at Months 0, 1, 3 and 6, and data from the study-provided wearable (Fitbit Charge 6) and sensors from the participant's smartphone (through the Brightline app) will be collected passively throughout. | Other | Undergraduate students |
Primary outcome
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)
A nine-item scale assessing depression severity. A higher total score indicates increased depression severity.
7 secondary outcomes
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)
Perceived Stress Scale 4 (PSS-4)
Time frame: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)
International Positive and Negative Affect Schedule - Short Form (I-PANAS-SF)
Time frame: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)
University of California Los Angeles, 3-Item Loneliness Scale (UCLA-3)
Time frame: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)
University Stress Scale (USS)
Time frame: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)
Mental Help Seeking Attitudes Scale (MHSAS)
Time frame: Baseline (Month 0), End-point (Month 6)
Perceptions of study compliance
Time frame: End-point (Month 6)
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 15 Jan 2025.
- Derived from this study: PubMed 40983586Ito S, Ang CS, Kampman OP, Rokde K, Buddhika T, Heaukulani C, Tan ZW, Dewanti FA, Au EWM, Huan VS, Morris RJ, Khong AWH, Ho AHY. Harnessing digital phenotyping to advance university student mental health (Brightline) in Singapore: study protocol for a prospective observational study. BMJ Open. 2025 Sep 22;15(9):e103652. doi: 10.1136/bmjopen-2025-103652.
- 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.
Andy WH Khong, PhD principal investigator
Nanyang Technological University
Andy HY Ho, PhD, EdD principal investigator
Nanyang Technological University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by Nanyang Technological University at 1 site in Singapore.
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 6 inclusion and 7 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 15 Jan 2025. 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 Singapore. 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. 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 Zhi Wei Tan, PhD (+65 92312575, zhiwei.tan@ntu.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (PHQ-9) (time frame: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06770075, which also lists 1 linked publication.
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 15 Jan 2025.