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Brightline: Advancing Mental Health on Campus

Brightline - a Digital Phenotyping Study Toward Advancing Mental Health on Campus

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06770075
Enrollment
500
Registered
2025-01-13
Start date
2025-01-31
Completion date
2026-03-31
Last updated
2025-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Loneliness, Negative Affect, Positive Affect, Stress

Keywords

university student, mental health, digital phenotyping, digital biomarkers, passive sensing, risk prediction, mental health seeking

Brief 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. 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.

Interventions

OTHERObservational

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.

Sponsors

MOH Office for Healthcare Transformation (MOHT), Singapore
CollaboratorUNKNOWN
Nanyang Technological University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Patient Health Questionnaire-9 (PHQ-9)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.

Secondary

MeasureTime frameDescription
Perceived Stress Scale 4 (PSS-4)Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)A four-item scale assessing stress severity. A higher total score indicates increased stress severity.
International Positive and Negative Affect Schedule - Short Form (I-PANAS-SF)Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)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.
University of California Los Angeles, 3-Item Loneliness Scale (UCLA-3)Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)A three-item scale assessing levels of loneliness. A higher total score indicates increased loneliness.
Generalized Anxiety Disorder-7 (GAD-7)Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)A seven-item scale assessing anxiety severity. A higher total score indicates increased anxiety severity.
Mental Help Seeking Attitudes Scale (MHSAS)Baseline (Month 0), End-point (Month 6)A nine-item scale assessing attitudes towards seeking mental health help. A higher score indicates more favorable attitudes towards seeking mental health assistance.
Perceptions of study complianceEnd-point (Month 6)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.
University Stress Scale (USS)Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)A 21-item scale assessing the degree to which university life events are perceived as stressful. A higher score indicates increased perceived stress.

Countries

Singapore

Contacts

Primary ContactZhi Wei Tan, PhD
zhiwei.tan@ntu.edu.sg+65 92312575

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026