NCT00251342

Brief Summary

The objective of the present study is to evaluate the effectiveness of postnatal depression screening by comparing the mental health outcome (at 6 months postpartum) of mothers under the Edinburgh Postnatal Depression Scale (EPDS) screening programme versus usual clinical practice (usual practice), using randomized controlled trial design. With the use of the EPDS for the screening of postnatal depression, it is expected that more mothers in need of intervention (including mental health intervention, guidance in childcare and parenting, counseling in family relationships, etc) will be picked up and offered appropriate intervention, compared to the usual practice. It is hypothesized that the mental health of the group of women under the EPDS screening programme will be better than those under the usual practice, on subsequent follow-up.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
460

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

1 active site

Status
unknown

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, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2005

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

April 5, 2007

Status Verified

April 1, 2007

First QC Date

November 9, 2005

Last Update Submit

April 4, 2007

Conditions

Depression, Postpartum

Keywords

Postnatal depressionRandomized controlled trialScreeningOutcomeEdinburgh Postnatal Depression Scale

Outcome Measures

Primary Outcomes (1)

  • Mother's mental health at 6 months postpartum, as measured on the EPDS and General Health Questionnaire-12 (GHQ-12), both being self-report questionnaires.

Secondary Outcomes (5)

  • Mother's parenting stress (measured by the Parenting Stress Index, a self-report questionnaire)

  • Marital relationship satisfaction (measured by the Chinese Kansas Marital Satisfaction Scale, a self-report questionnaire)

  • Marital status and employment status (both father and mother, where applicable) at 6 and 18 months postpartum

  • Child health measures, including weight at 6 and 18 months, number of hospitalizations and visits to doctors within the first 6 and 18 months as reported by mother

  • Mother's mental health outcome (EPDS and GHQ scores) at 18 months postpartum

Interventions

Edinburgh Postnatal Depression ScalePROCEDURE

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Chinese mothers of newborn babies \<= 2 months who are registered with the 4 Maternal and Child Health Centres under study;
  • Normally resident in Hong Kong (Hong Kong ID card holder, or HK Birth Certificate \[with status of permanent resident indicated established\] holder, or people who have been granted unconditional stay in Hong Kong, or passport holders having valid travel document showing the right to land in Hong Kong, or permission to land, or eligibility of HK permanent ID card verified, or entitlement to the right of abode in HK)

You may not qualify if:

  • Those who do not use the Chinese language (in both the written and spoken form);
  • Those who are under active psychiatric contact;
  • Those who delivered in hospitals which are still conducting their own EPDS screening programme.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternal and Child Health Centres, Department of Health

Hong Kong, China

RECRUITING

Related Publications (1)

  • Leung SS, Leung C, Lam TH, Hung SF, Chan R, Yeung T, Miao M, Cheng S, Leung SH, Lau A, Lee DT. Outcome of a postnatal depression screening programme using the Edinburgh Postnatal Depression Scale: a randomized controlled trial. J Public Health (Oxf). 2011 Jun;33(2):292-301. doi: 10.1093/pubmed/fdq075. Epub 2010 Sep 29.

    PMID: 20884642DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Psychiatric Status Rating Scales

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Dominic TS Lee, M.D.

    Department of Psychiatry, The Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

  • Shirley SL Leung, MPH

    Family Health Service, Department of Health, HKSAR

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia Leung

CONTACT

fhssro@dh.gov.hk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2005

First Posted

November 10, 2005

Study Start

October 1, 2005

Study Completion

January 1, 2008

Last Updated

April 5, 2007

Record last verified: 2007-04

Locations

CN(1)