RecruitingNCT05961306

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

Diagnostic Accuracy of the Stepped Screening Protocol and Its Screening Tools for Depression, Anxiety Disorders, Obsessive-compulsive Disorders and Posttraumatic Disorders in the Perinatal Period.


Sponsor

University Hospital, Ghent

Enrollment

1,800 participants

Start Date

Aug 10, 2023

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating how accurate a stepped screening protocol is for detecting perinatal mood disorders (depression and anxiety during and after pregnancy) in Dutch-speaking women. Researchers want to know if current screening tools can reliably identify women who need mental health support during and after pregnancy. **You may be eligible if...** - You are 18 or older - You are currently pregnant (between 20 and 24 weeks) or recently gave birth (6 to 10 weeks ago) - You speak Dutch **You may NOT be eligible if...** - You are under 18 years old - You do not speak Dutch - You are outside the specified pregnancy or postpartum time window Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTSCID 5

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.


Locations(2)

AZ St Lucas

Ghent, Oost-Vlaanderen, Belgium

AZ Groeninge

Kortrijk, West-Flanders, Belgium

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NCT05961306


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