Brightline - a Digital Phenotyping Study Toward Advancing Mental Health on Campus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire-9 (PHQ-9)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Patient Health Questionnaire-9 (PHQ-9)
时间窗: 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.
次要结局
- 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))
研究者
Andy Khong W H
Assoc Prof
Nanyang Technological University