Diagnostic Accuracy of the Stepped Screening Protocol and Its Screening Tools in the Perinatal Period.

Sponsor
University Hospital, Ghent
Study ID
NCT05961306
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • SCID 5 — DIAGNOSTIC_TEST
    SCID 5 is a semi-structured standard clinical interview. We will focus on current depressive episode, (hypo)manic episode, anxiety disorders, OCD and PTSD. The interview will be conducted by phone.

Study Details

It is known that 1 in 5 women experience psychological difficulties during their pregnancy or in the first year after giving birth. Unfortunately, in 75% of cases, these problems go undetected, resulting in the woman, her partner and the baby not receiving the proper care. For this reason, the Flemish government wants to screen all women in the perinatal period for their mental well-being using short questionnaires with the aim of referring them to appropriate care. Before they can recommend this screening to all women in the perinatal period, it is necessary to investigate the effectiveness of these short questionnaires, as well as the proposed stepped screening protocol. The investigators want to use this study to determine whether the questionnaires and the stepped screening protocol are sufficiently sensitive to detect mental health problems during this period. This means that they want to check whether the (future) moms who screen positive actually have problems and whether the (future) moms who screen negative effectively do not have psychological problems. In case of positive findings, teh investigators want to recommend that screening for psychological well-being should best be part of standard care in the future. Participants will be asked to answer some questions regarding depressive and anxiety symptoms using existing screening instruments (Whooley, GAD-2, EPDS and GAD-7). On the basis of an online application one can be assigned to the group that will be invited for a telephone interview by a study employee of the UZ Gent (psychologist or psyciatrist) to conduct a semi-structured interview within 2 weeks after completing these questions. The interviewer will ask questions about current psychological well-being and, where applicable, psychological problems in the past. The interviewer will not be aware of the responses to the questionnaires, so as not to be prejudiced. Being contacted for an interview does not necessarily mean that those women scored higher on the questionnaires, as they may also belong to the control group. In addition, a number of demographic data are requested (such as age, marital status, level of education, occupational category, how many pregnancies, number of other (living) children, (expected) delivery date, current forms of treatment (medications, psychotherapeutic interventions) and psychiatric history).

Key Dates

First listed
Jul 27, 2023
Start date
Aug 10, 2023
Status verified
Oct 2024
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
1,800 participants (estimated)

Arms

  • Arm: antenatal period
    Pregnant women between 20 and 24 weeks of pregnancy will be invited to participate
  • Arm: postnatal period
    Moms, 6 to 10 weeks after delivery will be invited to participate

Primary Outcome Measure

anxiety disorders [ Time Frame: max 2 weeks after screening ]

Central Contacts

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