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临床试验/NCT07382336
NCT07382336已完成不适用

A Mobile Application for Early Detection and Symptoms Trajectories of Postpartum Depression Using Ecological Momentary Assessment (EMA): A Prospective Cohort Validation Study

The Hong Kong Polytechnic University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Ecological Momentary Questions (Mood)

研究概览

简要总结

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.

详细描述

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.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • Psychiatric diagnosis (e.g., schizophrenia, intellectual disability or mood disorders), comorbid brain conditions (history of epilepsy, stroke, or brain tumors), or learning disabilities.

研究组 & 干预措施

Ecological momentary assessment group

干预措施: Ecological momentary assessment and retrospective assessment (Diagnostic Test)

结局指标

主要结局

Ecological Momentary Questions (Mood)

时间窗: 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.

Three momentary questions will be administered to assess participants' mood-two yes/no Whooley questions for depression, one question about anxiety, which questions will be mapped onto a five-point pictorial scale, ranging from 1 (lowest) to 5 (highest) points. The higher score means worse outcome.

Edinburgh Postnatal Depression Scale (EPDS)

时间窗: At the baseline and the end of each of the 6 months in the period.

Measures postnatal depression. Each item scores 0-3, and the total score ranges from 0 (min) to 30 (max). Higher score means worse depressive symptoms.

次要结局

  • Ecological Momentary Questions (Lifestyle and Physical Wellbeing)(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)(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)(At the baseline and the end of each of the 6 months in the period)
  • Post-study acceptance survey(The survey will be conducted via online when the participants complete 6-month study.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

LIN Jingxia Jessie

Assistant Professor

The Hong Kong Polytechnic University

研究点 (2)

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