- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07382336
A Mobile Application for Early Detection and Symptoms Trajectories of Postpartum Depression Using Ecological Momentary Assessment (EMA) (EMA For PND)
January 30, 2026 updated by: LIN Jingxia Jessie, The Hong Kong Polytechnic University
A Mobile Application for Early Detection and Symptoms Trajectories of Postpartum Depression Using Ecological Momentary Assessment (EMA): A Prospective Cohort Validation Study
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Estimated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jessie LIN, PhD
- Phone Number: +852 2766 6718
- Email: jx-jessie.lin@polyu.edu.hk
Study Locations
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-
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Hong Kong, Hong Kong
- Recruiting
- The Hong Kong Polytechnic University
-
Contact:
- Jessie LIN
- Email: jx-jessie.lin@polyu.edu.hk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Perinatal women
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Psychiatric diagnosis (e.g., schizophrenia, intellectual disability or mood disorders), comorbid brain conditions (history of epilepsy, stroke, or brain tumors), or learning disabilities.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Ecological momentary assessment group
|
The intervention includes daily EMA components, and monthly retrospective assessments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ecological Momentary Questions (Mood)
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.
|
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)
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.
|
At the baseline and the end of each of the 6 months in the period.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ecological Momentary Questions (Contextual)
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.
|
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.
|
|
Post-study acceptance survey
Time Frame: The survey will be conducted via online when the participants complete 6-month study.
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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.
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The survey will be conducted via online when the participants complete 6-month study.
|
|
Ecological Momentary Questions (Lifestyle and Physical Wellbeing)
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.
|
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)
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.
|
At the baseline and the end of each of the 6 months in the period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Jessie LIN, PhD, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2023
Primary Completion (Estimated)
April 1, 2026
Study Completion (Estimated)
April 1, 2026
Study Registration Dates
First Submitted
January 25, 2026
First Submitted That Met QC Criteria
January 25, 2026
First Posted (Actual)
February 2, 2026
Study Record Updates
Last Update Posted (Actual)
February 3, 2026
Last Update Submitted That Met QC Criteria
January 30, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20211291 (Other Grant/Funding Number: Hong Kong Health and Medical Research Fund)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
May need to seek approval of the funding body.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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