The screening is intended to identify (peri- and postnatal) depression and psychosocial stress. F30-F39 F40-F48
Conditions
Interventions
Group 1: Participants in gynecological or pediatric practices who were randomized to the intervention group receive a screening for depression and psychosocial stress during the routine pregnancy exam
however, they receive only the usual routine treatment (treatment as usual). Feedback and counseling regarding exceeded cut-offs are provided to participants in the control group only at the last asse
Sponsors
Klinikum Nürnberg, Universitätskliniken der Paracelsus Medizinischen Privatuniversität (PMU)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All pregnant women from the 30th week of pregnancy and parents of children up to 6 months old (latest entry into the study at the U5 check-up, when the child is 6 to 7 months old). Initially, one of the inclusion criteria was that participants or their children had to be insured with a participating health insurance company (BKK). However, the study's planning allowed for UPlusE to be opened to those insured with other statutory health insurance providers if recruitment fell short of expectations. Since this has occurred, UPlusE was officially opened to members of other statutory health insurance providers on July 1, 2024. The opening was fully implemented on July 9, 2024.
Exclusion criteria
Exclusion criteria: Exclusion criteria include lack of capacity to give consent or an inability to complete the questionnaires in the app (no smartphone, insufficient language or reading skills). This study thus excludes individuals who cannot operate a smartphone and those who do not speak sufficient German. Many people who do not yet have a sufficient command of the German language use translation programs on their smartphones. If pregnant individuals/parents understand the informed consent and questionnaires adequately with the help of translation programs, they can naturally be included – provided that this leads to sufficient German language skills.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the utilization of mental health practitioners (psychiatrists, psychotherapists, etc.) and counseling/support services, measured using a project-specific questionnaire at the U6 examination. Utilization is assessed at every possible data collection point (routine pregnancy examination in the 30th - 34th week of pregnancy, U3, U4, U5, and U6 examination). | — |
Secondary
| Measure | Time frame |
|---|---|
| Depression severity/symptoms of depression, measured with the EPDS (Edinburgh Postnatal Depression Scale) at every possible data collection point (routine pregnancy examination in the 30th - 34th week of pregnancy, U3, U4, U5, and U6). Parent-child relationship, measured with Scale 1 of the PBQ (Postpartum Bonding Questionnaire) at U3, U4, U5, and U6. Psychosocial stress, measured with the KID-PROTEKT Assessment at every possible data collection point (routine pregnancy examination in the 30th - 34th week of pregnancy, U3, U4, U5, and U6). Child regulation, measured with an adapted version of the SFS Questionnaire at U3, U4, U5, and U6. | — |
Countries
Germany
Contacts
Public ContactSusanne Simen
Klinikum Nürnberg, Universitätskliniken der Paracelsus Medizinischen Privatuniversität (PMU)
Outcome results
None listed