NCT07382336

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

January 25, 2026

Last Update Submit

January 30, 2026

Conditions

Postpartum Depression (PPD)

Keywords

Ecological momentary assessmentPostpartum depression

Outcome Measures

Primary Outcomes (2)

  • Ecological Momentary Questions (Mood)

    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)

    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 Outcomes (4)

  • 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.

Study Arms (1)

Ecological momentary assessment group

Diagnostic Test: Ecological momentary assessment and retrospective assessment

Interventions

Ecological momentary assessment and retrospective assessmentDIAGNOSTIC_TEST

The intervention includes daily EMA components, and monthly retrospective assessments.

Ecological momentary assessment group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Perinatal women

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Jessie LIN, PhD

    Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

    STUDY CHAIR

Central Study Contacts

Jessie LIN, PhD

CONTACT

+852 2766 6718jx-jessie.lin@polyu.edu.hk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 25, 2026

First Posted

February 2, 2026

Study Start

October 1, 2023

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

February 3, 2026

Record last verified: 2026-01

Locations

HK(1)