ClinicalTrials.gg
CompletedNCT06664593Updated Oct 29, 2024

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 in Depression, Postpartum, Puerperal Disorders and Depression During Pregnancy, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-29.

Sponsored by University Hospital, Ghent · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
378
Ages
18 Years and older
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Depression, Postpartum
  • Puerperal Disorders
  • Depression During Pregnancy
  • Anxiety
  • Anxiety Disorder/Anxiety State
  • Stress, Psychological
  • Risk Factors
03

In context

Depression, Postpartum

569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.

This study's enrollment of 378 is above the median of 223 across 100 observational studies indexed under Depression, Postpartum.

Browse Depression, Postpartum studies →

Lead sponsor

University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pregnant women aged ≥ 18 years, receiving regular care follow-up in a university hospital

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
378 participants (actual)
Target follow-up
34 Weeks
Patient registry
Yes

Groups and cohorts

  • 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

    Other: integrated perinatal mental health pathway

Interventions

  • Otherintegrated perinatal mental health pathway

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: from enrollment at 16 weeks of pregnancy to follow-up consult at 6-8 weeks postpartum

  2. 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

Secondary outcomes

  1. prevalence of depressive and anxiety symptoms

    Time frame: from enrollment at 16 weeks of pregnancy to follow-up consult at 6-8 weeks postpartum

07

Study locations

1 site
  • University Hospital Ghent
    Ghent, Belgium
08

References and documents

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 ↗

Individual participant data

Plan to share: 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06664593
Responsible party
Sponsor
First posted
Oct 29, 2024
Start date
Nov 20, 2018
Primary completion
Feb 18, 2020
Completion
Jul 30, 2020
Last update
Oct 29, 2024

Study contacts

Gilbert Lemmens, PhD
principal investigator · University Hospital Ghent/University Ghent

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion