Brightline: Advancing Mental Health on Campus

NCT06770075 | Recruiting

• 1 other identifier: IRB-2023-894
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire-9 (PHQ-9)

  A nine-item scale assessing depression severity. A higher total score indicates increased depression severity.

  Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)

Secondary Outcomes (7)

• Generalized Anxiety Disorder-7 (GAD-7)

  Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)

• Perceived Stress Scale 4 (PSS-4)

  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)

  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)

  Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)

• University Stress Scale (USS)

  Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)

Study Arms (1)

Undergraduate students

Undergraduate students from Nanyang Technological University

Other: Observational

Interventions

Observational OTHER

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.

Also known as: There will be no interventions involved in this study.

Undergraduate students

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Undergraduate students

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanyang Technological University: lead
• MOH Office for Healthcare Transformation (MOHT), Singapore: collaborator

Study Sites (1)

Nanyang Technological University

Singapore, 639798, Singapore

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Andy WH Khong, PhD

  Nanyang Technological University

  PRINCIPAL INVESTIGATOR

• Andy HY Ho, PhD, EdD

  Nanyang Technological University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi Wei Tan, PhD

CONTACT

+65 92312575; zhiwei.tan@ntu.edu.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 13, 2025
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)