NCT05961306 Diagnostic Accuracy of the Stepped Screening Protocol and Its Screening Tools in the Perinatal Period.
| NCT ID | NCT05961306 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Depressive; Episode, Major |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,800 participants |
| Start Date | 2023-08-10 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,800 participants in total. It began in 2023-08-10 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
Inclusion Criteria: * 18 years or older, antenatal period (20-24 th week of pregnancy) or postnatal period (6 to 10 weeks after birth) and Dutch-speaking. Exclusion Criteria: * \<18 years, non-Dutch speaking and outside the above mentioned period.
Contact & Investigator
Gilbert MD Lemmens, Prof dr
PRINCIPAL INVESTIGATOR
University Hospital, Ghent
Frequently Asked Questions
Who can join the NCT05961306 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Depressive; Episode, Major. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05961306 currently recruiting?
Yes, NCT05961306 is actively recruiting participants. Contact the research team at rita.vandamme@uzgent.be for enrollment information.
Where is the NCT05961306 trial being conducted?
This trial is being conducted at Ghent, Belgium, Kortrijk, Belgium.
Who is sponsoring the NCT05961306 clinical trial?
NCT05961306 is sponsored by University Hospital, Ghent. The principal investigator is Gilbert MD Lemmens, Prof dr at University Hospital, Ghent. The trial plans to enroll 1,800 participants.