Clinical trial NCT06770075: Brightline: Advancing Mental Health on Campus
Official title: Brightline - a Digital Phenotyping Study Toward Advancing Mental Health on Campus
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Nanyang Technological University
Sponsor class: OTHER
Collaborators: name: MOH Office for Healthcare Transformation (MOHT), Singapore
First posted: 2025-01-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Undergraduate students

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.

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.

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)
Secondary outcomes:
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)
measure: Perceived Stress Scale 4 (PSS-4)
timeFrame: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)
measure: International Positive and Negative Affect Schedule - Short Form (I-PANAS-SF)
timeFrame: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)
measure: University of California Los Angeles, 3-Item Loneliness Scale (UCLA-3)
timeFrame: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)
measure: University Stress Scale (USS)
timeFrame: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)
measure: Mental Help Seeking Attitudes Scale (MHSAS)
timeFrame: Baseline (Month 0), End-point (Month 6)
measure: Perceptions of study compliance
timeFrame: End-point (Month 6)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Nanyang Technological University
Study officials:
affiliation: Nanyang Technological University
name: Andy WH Khong, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanyang Technological University
name: Andy HY Ho, PhD, EdD
role: PRINCIPAL_INVESTIGATOR
References: