Brightline: Advancing Mental Health on Campus

January 13, 2025 updated by: Andy Khong W H, Nanyang Technological University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore, 639798
        • Recruiting
        • Nanyang Technological University
        • Contact:
        • Contact:
          • Andy WH Khong, PhD
        • Contact:
          • Andy HY Ho, PhD, EdD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Undergraduate students

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Undergraduate students
Undergraduate students from Nanyang Technological University
Other: Observational
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.
Other Names:
  • There will be no interventions involved in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: 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.
Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)
Perceived Stress Scale 4 (PSS-4)
Time Frame: 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.
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)
Time Frame: 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.
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)
Time Frame: 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.
Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)
University Stress Scale (USS)
Time Frame: 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.
Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)
Mental Help Seeking Attitudes Scale (MHSAS)
Time Frame: 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.
Baseline (Month 0), End-point (Month 6)
Perceptions of study compliance
Time Frame: 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.
End-point (Month 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanyang Technological University

Collaborators

MOH Office for Healthcare Transformation (MOHT), Singapore

Investigators

  • Principal Investigator: Andy HY Ho, PhD, EdD, Nanyang Technological University
  • Principal Investigator: Andy WH Khong, PhD, Nanyang Technological University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-2023-894

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Observational

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe