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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital, Ghent

About this trial

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

This trial accepts healthy volunteers

Qualifiers

18 years or older, antenatal period (20-24 th week of pregnancy) or postnatal period (6 to 10 weeks after birth) and Dutch-speaking.

Disqualifiers

<18 years, non-Dutch speaking and outside the above mentioned period.

Trial population

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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

1,800 Participants
are divided into 2 treatment groups
Group A: antenatal period1 intervention
Group B: postnatal period1 intervention

Trial outcomes

Primary outcomes

1

anxiety disorders

SCID-5

Time frame
max 2 weeks after screening

Secondary outcomes

1

depressive episode

SCID-5

Time frame
max 2 weeks after screening
2

(hypo)manic episode

SCID-5

Time frame
max 2 weeks after screening
3

OCD

SCID-5

Time frame
max 2 weeks after screening
4

PTSD

SCID-5

Time frame
max 2 weeks after screening

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.