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Clinical Trials/NCT06770075
NCT06770075
Recruiting
Not Applicable

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

Nanyang Technological University1 site in 1 country500 target enrollmentJanuary 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Nanyang Technological University
Enrollment
500
Locations
1
Primary Endpoint
Patient Health Questionnaire-9 (PHQ-9)
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2025
End Date
March 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andy Khong W H

Assoc Prof

Nanyang Technological University

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.

Outcomes

Primary Outcomes

Patient Health Questionnaire-9 (PHQ-9)

Time Frame: 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 Outcomes

  • Generalized Anxiety Disorder-7 (GAD-7)(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))
  • Mental Help Seeking Attitudes Scale (MHSAS)(Baseline (Month 0), End-point (Month 6))
  • Perceptions of study compliance(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))

Study Sites (1)

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