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. 2024 Nov 14;25(1):766.
doi: 10.1186/s13063-024-08610-y.

Identification and transfer to stepped care of depressed and psychosocially stressed parents during peri- and postpartum-UPlusE: study protocol for cluster randomized trial of a screening intervention

Ulrike Stentzel  1 , Neeltje van den Berg  2   3 , Freya Lanczik  4 , Andrea Gehrmann  4 , Ina Nehring  5   6 , Volker Mall  5   6 , Anna Friedmann  5   6 , Carolin Seivert  7 , Stefanie Schade  2 , Christoph Fusch  8 ; UPlusE-group; Sarah Kittel-Schneider  4   9   10 , Susanne Simen  7
Collaborators, Affiliations

Identification and transfer to stepped care of depressed and psychosocially stressed parents during peri- and postpartum-UPlusE: study protocol for cluster randomized trial of a screening intervention

Ulrike Stentzel et al. Trials. .

Abstract

Background: Perinatal depression affects 10-15% of mothers and approximately 5% of fathers. However, only a small number of affected individuals seek treatment. If left unrecognized and untreated, it can have negative long-term consequences for the family's health, leading to subsequent high costs. Early treatment is crucial, yet there is a notable underdiagnosis and undertreatment. Affected individuals are often seen during this time, e.g. in paediatric practices, but not by specialists in mental health. Consequently, this study aims to increase detection and treatment rates of affected individuals by implementing a screening for depression and psychosocial stress in perinatal and postpartum parents within routine obstetric and paediatric care with subsequent advice and-if necessary-further referral to a mental health specialist.

Methods: UPlusE is a prospective, cluster-randomized controlled trial conducted in an outpatient setting. Obstetric and paediatric practices will be randomized into an intervention and control group (1:1 ratio). Practices and enrolling patients will be required to use specific smartphone apps (practice apps) for interaction. The screening will occur with the apps at each paediatric checkup up to the child's age of 12 months, using the Edinburgh Postnatal Depression Scale (EPDS), KID-PROTEKT questionnaire, and the scale 1 (impaired bonding) of the Postpartum Bonding Questionnaire (PBQ-1). The goal is to screen 10,000 patients across Germany. Gynaecologists and paediatricians will receive certified training on peripartum depression. Participants in the intervention group with scores above cut-offs (EPDS ≥ 10, KID-PROTEKT ≥ 1, PBQ-1 ≥ 12) will receive counselling through their treating gynaecologists/paediatricians and will be provided with regional addresses for psychiatrists, psychotherapists, and "Frühe Hilfen" (early prevention) as well as family counselling centres, depending on symptom severity. At each screening, participants will be asked whether they sought support, where, and with whom (utilization). Utilization is the primary outcome.

Discussion: The screening is designed to reduce underdiagnosis to enable suitable support at an early stage (especially for those often overlooked, such as individuals with "high-functioning depression") and hence to avoid manifestation of mental health problems in the whole family, especially infants who are exceptionally dependent on their parents and their well-being will benefit from this program.

Trial registration: German Clinical Trials Register, DRKS00033385. Registered on 15 January 2024.

Keywords: Cost-effectiveness; EPDS; Infants; Mental health; PBQ; Postnatal depression; Psychosocial stress; Regulatory problems; Screening; Utilization.

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Conflict of interest statement

Declarations Ethics approval and consent to participate {24} An ethics vote was obtained from the Ethics Committee at University Medicine Greifswald, (BB 120/23 dated 08.08.2023). All participants will be thoroughly informed through the practice app and can access the patient information at any time. They will provide their consent within the practice app, which they can review at any time. The consent is unequivocally attributable to the participating individual. Consent for publication {32} No images or videos relating to individual persons will be gained. Hence, a consent for publication is not applicable. Competing interests {28} SKS is the PI of the Babylotsen project and study in Würzburg, which is funded by Deutsches Hilfswerk, Stiftung SeeYou, and Lion’s Club Würzburg. This is a similar screening project but only screening patients and guiding them to the suitable support services within the Department of Gynaecology and Obstetrics at the University Hospital Würzburg. All the other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
UPlusE design
Fig. 2
Fig. 2
UPlusE intervention flow
Fig. 3
Fig. 3
UPlusE schedule of enrolment, interventions, and assessments (SPIRIT)
See this image and copyright information in PMC

References

    1. Dorsch VM, Rohde A. Postpartale psychische Störungen–Update 2016. Frauenheilkunde up2date. 2016;10(04):355–74.
    1. Johansson M, Svensson I, Stenström U, Massoudi P. Depressive symptoms and parental stress in mothers and fathers 25 months after birth. J Child Health Care. 2017;21(1):65–73. - PubMed
    1. Kolodziej D, Wolkwitz P, Schön G, Siefert S, Pawils S. Evaluation of a Child-centred Psychosocial Healthcare Intervention (KIDPROTEKT)—results of a cluster randomized controlled trial in paediatric and gynaecologic practices. Psychosoc Interv. 2023;32(1):33–42. - PMC - PubMed
    1. Orsolini L, Valchera A, Vecchiotti R, Tomasetti C, Iasevoli F, Fornaro M, et al. Suicide during perinatal period: epidemiology, risk factors, and clinical correlates. Front Psychiatry. 2016;7:138. - PMC - PubMed
    1. Le Strat Y, Dubertret C, Le Foll B. Prevalence and correlates of major depressive episode in pregnant and postpartum women in the United States. J Affect Disord. 2011;135(1–3):128–38. - PubMed

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