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Recruiting NCT06770075

Brightline: Advancing Mental Health on Campus

— Observational Depression Anxiety Stress Positive Affect

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observational.
Who it may be relevant to
Registry conditions: Depression, Anxiety, Stress, Positive Affect. Basic parameters: 18 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other Observational
    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.

Primary outcome measures

  • Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)]
Secondary outcome measures (7)
  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Singapore · 1 center
  • Nanyang Technological University — Singapore

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. PMID 40983586

Identifiers

NCT: NCT06770075 · IRB-2023-894

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗