Depression, PostpartumPhase 2/3NCT00251342
Outcome of Postnatal Depression Screening Using Edinburgh Postnatal Depression Scale
A Phase 2/3 study testing Edinburgh Postnatal Depression Scale in people with Depression, Postpartum, run by Chinese University of Hong Kong at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Postpartum
- What is being tested?
- Edinburgh Postnatal Depression Scale
- Type of treatment
- Surgery or procedure
- How many people
- 460 participants
- Where
- 1 siteChina
- Study dates
- Oct 2005to Jan 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Cynthia Leung contact
China1 site, 1 recruiting
- Recruiting
Maternal and Child Health Centres, Department of Health
Hong Kong
Cynthia Leung, fhssro@dh.gov.hk
About this study
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.
- Conditions
- Depression, Postpartum
- Being tested
- Edinburgh Postnatal Depression Scale
- Keywords
- Postnatal depression, Randomized controlled trial, Screening, Outcome, Edinburgh Postnatal Depression Scale
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edinburgh Postnatal Depression ScaleProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2005 (estimated)
- Study startOct 2005
- Study completionJan 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression, PostpartumStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 460 participants
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Kong Department of Health, The University of Hong Kong
- Investigators
- Dominic TS Lee, M.D., Principal investigator, Department of Psychiatry, The Chinese University of Hong KongShirley SL Leung, MPH, Principal investigator, Family Health Service, Department of Health, HKSAR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251342
- Sponsor's protocol ID
- CRE-2005.224-T
- Other IDs
- CUHK_CCT00019
- Status last verified
- Apr 2007
- First submitted
- 9 Nov 2005
- Last updated
- 5 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20884642
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Postnatal Depression Screening Using Edinburgh Postnatal Depression Scale
- ClinicalTrials.gov ID
- NCT00251342
- Acronym / sponsor ID
- CRE-2005.224-T
- Conditions
- Depression, Postpartum
- Keywords
- Postnatal depression, Randomized controlled trial, Screening, Outcome, Edinburgh Postnatal Depression Scale
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 460 participants
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Hong Kong Department of Health, The University of Hong Kong
- Study start
- Oct 2005
- Study completion
- Jan 2008 (estimated)
- First posted
- 10 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edinburgh Postnatal Depression Scale | Procedure or surgery | – |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2007.
- Derived from this study: PubMed 20884642Leung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Leung contact
Dominic TS Lee, M.D. principal investigator
Department of Psychiatry, The Chinese University of Hong Kong
Shirley SL Leung, MPH principal investigator
Family Health Service, Department of Health, HKSAR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Edinburgh Postnatal Depression Scale in people with Depression, Postpartum, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cynthia Leung (fhssro@dh.gov.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00251342, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2007.