Brightline: Advancing Mental Health on Campus

Recruiting

• Conditions: Depression; Anxiety; Stress; Positive Affect; Negative Affect; Loneliness

• Registration Number: NCT06770075
• Lead Sponsor: Nanyang Technological University

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.

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Study First Posted: 2025-01-13
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-12
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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 compliance	End-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.
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.

Trial Locations

Locations (1)

Nanyang Technological University; 🇸🇬 Singapore, Singapore