Depression, PostpartumNCT06664593
Screening for Depression and Anxiety in Pregnant and Postpartum Women: Evaluating Prevalence, Risk Factors, and the Stepped Screening Protocol in a Care Pathway
An observational study of Depression, Postpartum and Puerperal Disorders, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Postpartum, Puerperal Disorders, Depression During Pregnancy
- What is being tested?
- integrated perinatal mental health pathway
- How many people
- 378 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Nov 2018to 30 Jul 2020
- How long will I take part?
- 34 Weeks
- Phase
- Observational
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of women receiving regular care during pregnancy and postpartum follow-up at the women\'s clinic of University Hospital Ghent
Who may be able to join
- Pregnant women aged ≥ 18 years, receiving regular care follow-up in a university hospital
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read more
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.
- Conditions
- Depression, Postpartum, Puerperal Disorders, Depression During Pregnancy, Anxiety, Anxiety Disorder/Anxiety State, Stress, Psychological
- Being tested
- integrated perinatal mental health pathway
- Medical subject headings
- Depression, Postpartum, Puerperal Disorders, Anxiety Disorders, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrated perinatal mental health pathwayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: integrated perinatal mental health pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
association of psychosocial and obstetric risk factors with perinatal anxiety and depression
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.
Measured: from enrollment at 16 weeks of pregnancy to follow-up consult at 6-8 weeks postpartum
association between the number of (significant) risk factors and depressive and anxiety symptoms using a cumulative risk index
Measured: from enrollment at 16 weeks of pregnancy to follow-up consult at 6-8 weeks postpartum
Secondary outcomes (1)
prevalence of depressive and anxiety symptoms
Measured: from enrollment at 16 weeks of pregnancy to follow-up consult at 6-8 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start20 Nov 2018
- Primary completion18 Feb 2020
- Study completion30 Jul 2020
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 University Hospital, GhentThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 378 participants (actual)
- Target duration
- 34 Weeks
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilbert Lemmens, PhD, Principal investigator, University Hospital Ghent/University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664593
- Sponsor's protocol ID
- 198215
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have decided not to share the IPD collected throughout the trial due to concerns over participant privacy and data confidentiality. Despite efforts to anonymize the data, there remains a risk that sensitive personal information could be inadvertently disclosed.
Publications
Van Damme R, Van Parys AS, Vogels C, Roelens K, Lemmens GMD. A mental health care protocol for the screening, detection and treatment of perinatal anxiety and depressive disorders in Flanders. J Psychosom Res. 2020 Jan;128:109865. doi: 10.1016/j.jpsychores.2019.109865. Epub 2019 Nov 1. No abstract available.
PubMed 31838308
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Perinatal Mental Disorders
- ClinicalTrials.gov ID
- NCT06664593
- Acronym / sponsor ID
- 198215
- Conditions
- Depression, Postpartum, Puerperal Disorders, Depression During Pregnancy, Anxiety, Anxiety Disorder/Anxiety State, Stress, Psychological
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 29 Oct 2024 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 34 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women in the perinatal period, from pregnancy until 6-8 weeks postpartum | – | Other: integrated perinatal mental health pathwaywomen from pregnancy until 6-8 weeks postpartum with and without mental health problems |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of women receiving regular care during pregnancy and postpartum follow-up at the women\'s clinic of University Hospital Ghent
Key inclusion criteria (1 listed)
- Pregnant women aged ≥ 18 years, receiving regular care follow-up in a university hospital
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| integrated perinatal mental health pathwayThis 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. | Other | women in the perinatal period, from pregnancy until 6-8 weeks postpartum |
Primary outcome
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
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.
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
1 secondary outcome
prevalence of depressive and anxiety symptoms
Time frame: from enrollment at 16 weeks of pregnancy to follow-up consult at 6-8 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Background: PubMed 31838308Van Damme R, Van Parys AS, Vogels C, Roelens K, Lemmens GMD. A mental health care protocol for the screening, detection and treatment of perinatal anxiety and depressive disorders in Flanders. J Psychosom Res. 2020 Jan;128:109865. doi: 10.1016/j.jpsychores.2019.109865. Epub 2019 Nov 1. No abstract available.
- Individual participant dataSharing planned: No. We have decided not to share the IPD collected throughout the trial due to concerns over participant privacy and data confidentiality. Despite efforts to anonymize the data, there remains a risk that sensitive personal information could be inadvertently disclosed.
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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.
Gilbert Lemmens, PhD principal investigator
University Hospital Ghent/University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, Postpartum and Puerperal Disorders, run by University Hospital, Ghent at 1 site in Belgium.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Oct 2024. 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 Belgium. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. 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 NCT06664593, 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 29 Oct 2024.