The Hong Kong Polytechnic University
Hong Kong
Location status: Recruiting
NCT Number: NCT07382336
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Hong Kong
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention includes daily EMA components, and monthly retrospective assessments.
Time frame: 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.
Time frame: 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.
Time frame: 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' sleep, exercise and physical pain/fatigue; they will be either mapped onto a five-point pictorial scale, ranging from 1 (min) to 5 (max) points (sleep) or presented using yes/no questions (exercise and physical pain/fatigue). For sleep, the higher score means better outcome.
Time frame: 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.
Two contextual questions will be administered to complement the momentary mood questions. They will assess participants' location and the activity in which they are engaged at the time they answer the six momentary questions.
Time frame: At the baseline and the end of each of the 6 months in the period
Measures stress symptoms. Each item scores 0-3, the total score for stress ranges from 0 (min) to 21 (max). Higher score means worse symptoms of stress.
Time frame: The survey will be conducted via online when the participants complete 6-month study.
A questionniare at the end of the six-month study period to assess the acceptability of the app to participants in the context of their prenatal and postnatal care and to collect feedback about their experience with the app.
Contact information is provided by the study sponsor or research team.
The Hong Kong Polytechnic University
Other
A Mobile Application for Early Detection and Symptoms Trajectories of Postpartum Depression Using Ecological Momentary Assessment (EMA): A Prospective Cohort Validation Study
Acronym: EMA For PND
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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