Outcome of Postnatal Depression Screening Using Edinburgh Postnatal Depression Scale

Depression, Postpartum Clinical Trial

Official title:

Outcome of Postnatal Depression Screening Using Edinburgh Postnatal Depression Scale

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00251342
• Other study ID #: CRE-2005.224-T
• Secondary ID: CUHK_CCT00019
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 9, 2005
• Last updated: April 4, 2007
• Start date: October 2005
• Est. completion date: January 2008

Study information

• Verified date: April 2007
• Source: Chinese University of Hong Kong
• Contact: Cynthia Leung
• Email: fhssro[@]dh.gov.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Chinese mothers of newborn babies <= 2 months who are registered with the 4 Maternal and Child Health Centres under study;

2. 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)

Exclusion Criteria:

1. Those who do not use the Chinese language (in both the written and spoken form);

2. Those who are under active psychiatric contact;

3. Those who delivered in hospitals which are still conducting their own EPDS screening programme.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder

Intervention

Procedure:
• Edinburgh Postnatal Depression Scale

Locations

Country	Name	City	State
China	Maternal and Child Health Centres, Department of Health	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Hong Kong Department of Health, The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mother's parenting stress (measured by the Parenting Stress Index, a self-report questionnaire)
Secondary	Marital relationship satisfaction (measured by the Chinese Kansas Marital Satisfaction Scale, a self-report questionnaire)
Secondary	Marital status and employment status (both father and mother, where applicable) at 6 and 18 months postpartum
Secondary	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
Secondary	Mother's mental health outcome (EPDS and GHQ scores) at 18 months postpartum