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NCT Number: NCT06770075

Brightline: 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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Loneliness Mental Disorders Negative Affect Personal Satisfaction Positive Affect Psychological Well-Being Stress

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanyang Technological University

Singapore, 639798

Location status: Recruiting

Location contact

Andy HY Ho, PhD, EdD

CONTACT

Andy WH Khong, PhD

CONTACT

Zhi Wei Tan, PhD

CONTACT

[email protected]

+65 92312575

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational

Other

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.

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhi Wei Tan, PhD

CONTACT

[email protected]

+65 92312575

Sponsors and collaborators

Lead sponsor

Nanyang Technological University

Other

Collaborators

  • Ministry of Health, Singapore

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 13, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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