Brightline: Advancing Mental Health on Campus

NCT ID: NCT06770075

Last Updated: 2025-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-31

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression Anxiety Stress Positive Affect Negative Affect Loneliness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Undergraduate students

Undergraduate students from Nanyang Technological University

Observational

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

There will be no interventions involved in this study.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

MOH Office for Healthcare Transformation (MOHT), Singapore

UNKNOWN

Sponsor Role collaborator

Nanyang Technological University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Andy Khong W H

Assoc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andy WH Khong, PhD

Role: PRINCIPAL_INVESTIGATOR

Nanyang Technological University

Andy HY Ho, PhD, EdD

Role: PRINCIPAL_INVESTIGATOR

Nanyang Technological University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nanyang Technological University

Singapore, , Singapore

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Singapore

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zhi Wei Tan, PhD

Role: CONTACT

+65 92312575

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zhi Wei Tan, PhD

Role: primary

+65 92312575

Andy WH Khong, PhD

Role: backup

Andy HY Ho, PhD, EdD

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

Ito S, Ang CS, Kampman OP, Rokde K, Buddhika T, Heaukulani C, Tan ZW, Dewanti FA, Au EWM, Huan VS, Morris RJ, Khong AWH, Ho AHY. Harnessing digital phenotyping to advance university student mental health (Brightline) in Singapore: study protocol for a prospective observational study. BMJ Open. 2025 Sep 22;15(9):e103652. doi: 10.1136/bmjopen-2025-103652.

Reference Type DERIVED
PMID: 40983586 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB-2023-894

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mental Health App and Impact on Wellbeing
NCT07331922 NOT_YET_RECRUITING NA
Economic Evaluation of Mindline.sg
NCT07209904 ACTIVE_NOT_RECRUITING NA
Self-help App and Wellbeing
NCT04911803 COMPLETED NA
Brain Health on College Campuses
NCT06724887 RECRUITING NA