A Mobile Application for Early Detection and Symptoms Trajectories of Postpartum Depression Using Ecological Momentary Assessment (EMA) (EMA For PND)

September 16, 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Hong Kong Polytechnic University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Ecological momentary assessment group
Diagnostic test: Ecological momentary assessment and retrospective assessment
The intervention includes daily EMA components, and monthly retrospective assessments.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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