Меню
Идёт набор NCT06770075

Brightline: Advancing Mental Health on Campus

— Наблюдательное Depression Anxiety Stress Positive Affect

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Observational.
Кому может быть актуально
Состояния в реестре: Depression, Anxiety, Stress, Positive Affect. Базовые параметры: 18 лет — 25 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Сингапур
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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.

Первичные конечные точки

  • Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)]
Вторичные конечные точки (7)
  • Generalized Anxiety Disorder-7 (GAD-7) [Срок оценки: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)]
  • Perceived Stress Scale 4 (PSS-4) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)]
  • University Stress Scale (USS) [Срок оценки: Baseline (Month 0), Interim (Month 1), Mid-point (Month 3), End-point (Month 6)]
  • Mental Help Seeking Attitudes Scale (MHSAS) [Срок оценки: Baseline (Month 0), End-point (Month 6)]
  • Perceptions of study compliance [Срок оценки: End-point (Month 6)]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Сингапур · 1 центр
  • Nanyang Technological University — Singapore

Публикации

  • 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. PMID 40983586

Идентификаторы

NCT: NCT06770075 · IRB-2023-894

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗