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
Official title: Detection of Perinatal Mental Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression, Postpartum
Puerperal Disorders
Depression During Pregnancy
Anxiety
Anxiety Disorder/Anxiety State
Stress, Psychological
Risk Factors
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 378
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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\&#39;s clinic of University Hospital Ghent

Brief 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\&#39;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.


Eligibility criteria: 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.

Primary outcomes:
measure: association of psychosocial and obstetric risk factors with perinatal anxiety and depression
timeFrame: from enrollment at 16 weeks of pregnancy to follow-up consult at 6-8 weeks postpartum
measure: association between the number of (significant) risk factors and depressive and anxiety symptoms using a cumulative risk index
timeFrame: from enrollment at 16 weeks of pregnancy to follow-up consult at 6-8 weeks postpartum
Secondary outcomes:
measure: prevalence of depressive and anxiety symptoms
timeFrame: from enrollment at 16 weeks of pregnancy to follow-up consult at 6-8 weeks postpartum
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital Ghent/University Ghent
name: Gilbert Lemmens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.