Brightline: Advancing Mental Health on Campus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-25
SponsorNanyang Technological University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Undergraduate students
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observational
Other interventionParticipants 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.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Undergraduate students1 intervention
Trial outcomes
Primary outcomes
1
Patient Health Questionnaire-9 (PHQ-9)
A nine-item scale assessing depression severity. A higher total score indicates increased depression severity.
Time frame
Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)Secondary outcomes
1
Generalized Anxiety Disorder-7 (GAD-7)
A seven-item scale assessing anxiety severity. A higher total score indicates increased anxiety severity.
Time frame
Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)2
Perceived Stress Scale 4 (PSS-4)
A four-item scale assessing stress severity. A higher total score indicates increased stress severity.
Time frame
Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)3
International Positive and Negative Affect Schedule - Short Form (I-PANAS-SF)
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.
Time frame
Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)4
University of California Los Angeles, 3-Item Loneliness Scale (UCLA-3)
A three-item scale assessing levels of loneliness. A higher total score indicates increased loneliness.
Time frame
Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nanyang Technological University
Lead sponsor
Ministry of Health, Singapore
Collaborator
Source ClinicalTrials.gov