- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06664593
Screening for Depression and Anxiety in Pregnant and Postpartum Women: Evaluating Prevalence, Risk Factors, and the Stepped Screening Protocol in a Care Pathway
Detection of Perinatal Mental Disorders
Having a baby is a major life event, and for some women, it can increase the risk of developing mental health issues. A recent survey in the UK found that one in five women experience mental health problems during pregnancy or after giving birth. Unfortunately, many of these problems go unnoticed without regular check-ups, and only one in ten women receive the support they need. Regular mental health screenings can help detect these problems early, ensuring women receive the right care and support.
The study at UZ Gent aims to improve how depression and anxiety are detected in pregnant and postpartum women by using a perinatal screening protocol. This protocol involves screening women for psychosocial risks around the 16th week of pregnancy, which is done by a midwife. Further screenings take place during the second trimester (around 20 weeks) and again six weeks after birth, using questionnaires to assess for depression and anxiety (Whooley, EPDS, GAD-2, GAD-7).
If the assessment of risk factors or the screening for depression and anxiety is positive, further assessment and treatment are offered at the women's clinic. A positive screening may lead to a recommendation for a diagnostic interview, such as a semi-structured interview (M.I.N.I.), with a psychiatrist, general practitioner, or psychologist to assess for possible depression or anxiety disorders. If needed, appropriate treatment will be provided.
The study will explore how common depression and anxiety are during and after pregnancy, what factors increase the risk, and whether the screening process improves early detection and treatment. The ultimate goal is to help more women get the mental health support they need during this critical time.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Ghent, Belgium
- University Hospital Ghent
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pregnant women aged ≥ 18 years, receiving regular care follow-up in a university hospital
Exclusion Criteria:
- Non-Dutch speakers were excluded. Additionally, no data were collected from women in the vulnerable care pathway, which provides psychosocial support to those facing barriers in employment, income, housing, education, and healthcare. This group includes teenage mothers (under 18), women with intellectual disabilities, new immigrants, refugees, homeless women, and those with severe psychiatric or addiction issues referred by their psychiatrist or GP.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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women in the perinatal period, from pregnancy until 6-8 weeks postpartum
women from pregnancy until 6-8 weeks postpartum with and without mental health problems
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This observational study examines whether assessing psychosocial risk factors and screening for depression and anxiety at different time points during the perinatal period, using a stepped protocol, helps to more quickly detect women with depressive and anxiety symptoms.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
association of psychosocial and obstetric risk factors with perinatal anxiety and depression
Time Frame: from enrollment at 16 weeks of pregnancy to follow-up consult at 6-8 weeks postpartum
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Using a semi-structured interview, the midwife assesses psychosocial risk factors identified from a literature review. Key factors include financial and housing problems, unplanned or unwanted pregnancy, lack of social support, experiences of violence (physical, sexual, or emotional), personal and family psychiatric history, and substance use. Screening for depressive and anxiety symptoms followed a stepped protocol. All participants answered Yes/No to the Whooley questions (depression) and GAD-2 (anxiety). If a participant answered positively to at least one Whooley question or both GAD-2 questions, the Edinburgh Depression Scale (EDS) was administered. A score of 13 or higher on the EDS indicated a positive depression screen. If participants scored 5 or higher on the EDS-3A (anxiety subscale), the GAD-7 was administered, with a score of 15 or higher indicating a positive anxiety screen. Obstetric information was collected from the electronic patient medical records. |
from enrollment at 16 weeks of pregnancy to follow-up consult at 6-8 weeks postpartum
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association between the number of (significant) risk factors and depressive and anxiety symptoms using a cumulative risk index
Time Frame: from enrollment at 16 weeks of pregnancy to follow-up consult at 6-8 weeks postpartum
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from enrollment at 16 weeks of pregnancy to follow-up consult at 6-8 weeks postpartum
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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prevalence of depressive and anxiety symptoms
Time Frame: from enrollment at 16 weeks of pregnancy to follow-up consult at 6-8 weeks postpartum
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from enrollment at 16 weeks of pregnancy to follow-up consult at 6-8 weeks postpartum
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gilbert Lemmens, PhD, University Hospital Ghent/University Ghent
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 198215
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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