A Mobile Application for Early Detection and Symptoms Trajectories of Postpartum Depression Using Ecological Momentary Assessment (EMA)
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: Ecological momentary assessment and retrospective assessment.
- Кому может быть актуально
- Состояния в реестре: Postpartum Depression (PPD). Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Гонконг
- 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
A Mobile Application for Early Detection and Symptoms Trajectories of Postpartum Depression Using Ecological Momentary Assessment (EMA): A Prospective Cohort Validation Study
Обзор
This pilot study will recruit 120 perinatal pregnant women and follow them up for 6 months. Both momentary and retrospective assessments of emotional well-being and psychosocial factors will be conducted on a mobile application. We aim to understand the symptom trajectories and provide evidence for effective individualized interventions.
Подробное описание
The proposed study addresses the knowledge gaps regarding the validity of mobile-based ecological momentary assessment (EMA) for dynamic patterns of mood symptoms and associated factors in women during pregnancy through postnatal period. The investigators hypothesize that the validity of mobile-based EMA is appropriate in women during pregnancy through postnatal period and that participants will exhibit at least two trajectories of depressive symptoms with high and low severity over a six-month period from the third trimester to three months postpartum. This prospective study using single group design will recruit 120 pregnant women for a six-month period. Clinical and self-rating assessments of mood symptoms and lifestyle information will be conducted on a mobile application. There will be a total of six periods EMA assessments and seven retrospective assessments. Six EMA questions for mood, sleep, exercise, physical well-being, and environmental context will be administered three times daily for five consecutive days, and the Edinburgh Postnatal depression Scale will be assessed at baseline and each month during the six-month period. Descriptive and inferential statistics will be used to examine the feasibility and validity of mobile-based EMA. Hierarchical cluster analysis and multiple regression model will be used to identify trajectories of depressive symptoms, and associated factors.
Вмешательства
- Диагностический тест Ecological momentary assessment and retrospective assessment
The intervention includes daily EMA components, and monthly retrospective assessments.
Первичные конечные точки
- Ecological Momentary Questions (Mood) [Срок оценки: Three momentary assessments per day for five days in each month for 6 months, displayed randomly within each of the following intervals: 0900-1300, 1300-1800 and 1800-0000.]
- Edinburgh Postnatal Depression Scale (EPDS) [Срок оценки: At the baseline and the end of each of the 6 months in the period.]
Вторичные конечные точки (4)
- Ecological Momentary Questions (Lifestyle and Physical Wellbeing) [Срок оценки: Three momentary assessments per day for five days in each month for 6 months, displayed randomly within each of the following intervals: 0900-1300, 1300-1800 and 1800-0000.]
- Ecological Momentary Questions (Contextual) [Срок оценки: Three momentary assessments per day for five days in each month for 6 months, displayed randomly within each of the following intervals: 0900-1300, 1300-1800 and 1800-0000.]
- Depression Anxiety and Stress Scale 21 (DASS-21) [Срок оценки: At the baseline and the end of each of the 6 months in the period]
- Post-study acceptance survey [Срок оценки: The survey will be conducted via online when the participants complete 6-month study.]
Критерии участия
Критерии включения
- Pregnant women in their first and second trimesters.
- Aged 18 years and older.
- Able to read and understand Chinese
- Own a smartphone with iOS or Android system.
Критерии исключения
- Psychiatric diagnosis (e.g., schizophrenia, intellectual disability or mood disorders), comorbid brain conditions (history of epilepsy, stroke, or brain tumors), or learning disabilities.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Гонконг · 1 центр
- The Hong Kong Polytechnic University — Гонконг
Идентификаторы
NCT: NCT07382336 · 20211291 · 20211291