NCT05961306: DAS

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

Recruiting now Last updated 30 October 2024

What this trial tests

trial testing SCID 5 in Depressive; Episode, Major in 1,800 participants. Currently enrolling.

Timeline

10 August 2023

Primary endpoint
30 June 2025

30 June 2025

Quick facts

Lead sponsor	University Hospital, Ghent
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	1,800
Start date	10 August 2023
Primary completion	30 June 2025
Estimated completion	30 June 2025
Sites	2 locations across Belgium

Drugs / interventions tested

• SCID 5

Conditions studied

• Depressive; Episode, Major — all drugs for Depressive; Episode, Major →
• Depression, Postpartum — all drugs for Depression, Postpartum →
• Anxiety Disorders — all drugs for Anxiety Disorders →
• Obsessive-Compulsive Disorder — all drugs for Obsessive-Compulsive Disorder →

Sponsor

University Hospital, Ghent

Who can join

18 and older, female only, with Depressive; Episode, Major or Depression, Postpartum. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.