Diagnostic Accuracy of the Stepped Screening Protocol and Its Screening Tools in the Perinatal Period.
DAS
1 other identifier
observational
1,800
1 country
2
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2023
CompletedFirst Posted
Study publicly available on registry
July 27, 2023
CompletedStudy Start
First participant enrolled
August 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedOctober 30, 2024
October 1, 2024
1.9 years
July 17, 2023
October 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
anxiety disorders
SCID-5
max 2 weeks after screening
Secondary Outcomes (4)
depressive episode
max 2 weeks after screening
(hypo)manic episode
max 2 weeks after screening
OCD
max 2 weeks after screening
PTSD
max 2 weeks after screening
Study Arms (2)
antenatal period
Pregnant women between 20 and 24 weeks of pregnancy will be invited to participate
postnatal period
Moms, 6 to 10 weeks after delivery will be invited to participate
Interventions
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.
Eligibility Criteria
This study will be conducted through 2 hospitals (AZ Groeninge, Kortrijk and AZ St Lucas, Ghent) encouraging their pregnant and/or recently delivered mothers to participate in this study by means of flyers. If there is a shortage of participants, this study can also be spread via the website and social media of https://wolkinmijnhoofd.be (initiative of UZ Gent).
You may qualify if:
- years or older, antenatal period (20-24 th week of pregnancy) or postnatal period (6 to 10 weeks after birth) and Dutch-speaking.
You may not qualify if:
- \<18 years, non-Dutch speaking and outside the above mentioned period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
AZ St Lucas
Ghent, Oost-Vlaanderen, 9000, Belgium
AZ Groeninge
Kortrijk, West-Flanders, 8500, Belgium
Related Publications (1)
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.
PMID: 31838308BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gilbert MD Lemmens, Prof dr
University Hospital, Ghent
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2023
First Posted
July 27, 2023
Study Start
August 10, 2023
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
October 30, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share