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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital, Ghent
- Enrollment
- 1,800
- Locations
- 2
- Primary Endpoint
- anxiety disorders
Study Overview
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).
Detailed Description
This research follows an ongoing study at UZ Gent (registration number B670201836088).
In order to investigate the stepped screening instrument proposed therein for its value in clinical practice, it is important to 1) gain insight into the diagnostic accuracy of its individual screening instruments and 2) examine whether the implementation of the stepped screening protocol leads to better predictability in identifying women at increased risk of a major depressive episode and/or anxiety disorders, with inclusion of posttraumatic stress disorder (PTSD) and obsessive-compulsive disorder (OCD) in the perinatal period.
The diagnostic accuracy of the Edinburgh Postnatal Depression Scale (EPDS) shows good accuracy for major depression in both the ante- and postnatal periods and for any psychiatric disorder postnatally. The Whooley questions also have high diagnostic accuracy for depression and any psychiatric disorder in pregnancy and postnatally . Negative responses to both Whooley questions excluded with acceptable accuracy both perinatal depression and anxiety disorder.
For anxiety instruments, research to date is less unequivocal. The NICE Guidelines recommend the use of the Generalized Anxiety Disorder (GAD-2) (cut-off ≥ 3) for screening for anxiety symptoms based on research in a non-perinatal population (NICE - 2011). However, research shows that the GAD-2 is not specific enough to detect anxiety disorders in general, given that the population prevalence of generalized anxiety disorder (GAD) is only 5% (compared to 17% for all anxiety disorders). As possible good alternatives to the GAD-2, the use of the EDS-3A (a subset of the EPDS) and the GAD-7 are recommended.
This study aims to examine whether the screening protocol using the Whooley (clinical score, score 1) and GAD-2 (clinical score, score 2) as triage instruments followed by the EPDS/EDS-3A and GAD-7 should be updated for detecting a depressive episode, anxiety disorder or another psychiatric disorder ((hypo)manic episode in the context of bipolar disorder, OCD and/or PTSD). To our knowledge, to date, no studies are known concerning the validation of the above-mentioned screening instruments, nor concerning prevalence rates for the above-mentioned disorders for Flanders. This study will contribute to that.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
anxiety disorders
Time Frame: max 2 weeks after screening
SCID-5
Secondary Outcomes
- PTSD(max 2 weeks after screening)
- depressive episode(max 2 weeks after screening)
- OCD(max 2 weeks after screening)
- (hypo)manic episode(max 2 weeks after screening)