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Completed

NCT Number: NCT06664593

Screening for Depression and Anxiety in Pregnant and Postpartum Women: Evaluating Prevalence, Risk Factors, and the Stepped Screening Protocol in a Care Pathway

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.

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Key information

Conditions

Depression, Postpartum Anxiety Anxiety Disorder/Anxiety State Anxiety Disorders Behavior Behavioral Symptoms Depression During Pregnancy Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Risk Factors Stress, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Ghent

Ghent, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

integrated perinatal mental health pathway

Other

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.

Primary outcomes

  1. 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.

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

Detection of Perinatal Mental Disorders

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 29, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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