Trial document



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  DRKS00013339

Trial Description

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Title

Prevalence, symptomatology, and moderating factors of paternal postpartum depressive syndromes and the healthcare situation in Germany

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Trial Acronym

PPDfathers

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URL of the Trial

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Brief Summary in Lay Language

The central aim of the project is to close research gaps regarding paternal postpartum depressive syndromes in Germany. A cross-sectional epidemiological study aims to compare as primary outcome the prevalence of paternal PPD with the prevalence of depressive syndromes in the general male population. In two structurally differing study regions, a random sample of 2,300 fathers and a matched sample of 2,300 men without paternity over the last 12 months were questioned by using questionnaires for depressive symptoms (PHQ-9). Contact data are received from population registration offices as a random sample of the fathers and a matched control group. One of the secondary outcomes of the current project is to provide more sophisticated insights into the symptoms and moderating factors of paternal PPD. Another objective is to survey the current care situation regarding paternal PPD in Germany. The findings are intended to contribute to closing the above-mentioned research gaps and provide opportunities for the practice-oriented design of current care, and thus information on the development of screening methods and supply concepts, among others, to prevent, intervene and identify important access routes to the care system and to improve networking between the different occupational groups involved.

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Brief Summary in Scientific Language

To identify differences in the prevalence of depressive syndromes in fathers in the first year after the childbirth compared to a sample of men without a newborn child, matched on age, nationality and marital status, a cross-sectional epidemiological study will be carried out by using an anonymous questionnaire survey. Based on the data from the questionnaire survey, the differences in the prevalence for different periods should be determined and the current medical care of fathers with PPD recorded in the study region. The chosen study regions are Freiburg and Mannheim. The contact details of the young fathers and the matched comparison sample are obtained from the registration offices. Because social factors may influence the development of depressive syndromes after the childbirth, two cities varying within the population structure were chosen. By including these structurally very different cities, the studies external validity can be increased. The planned study will use an instrument with particularly good psychometric characteristics (PHQ-9, Patient Health Questionnaire). Instead of comparing the gained results to findings from interviews, as it was done in other studies, the data in this study will be compared to a matched sample by using the same instrument. By establishing a direct comparison design using the same instruments, the risk of over- or underestimating the relative frequency of depressive syndromes after childbirth can be lowered and the scientific quality of the statements can be increased. Furthermore, the date of birth and the date of answering the questionnaire are recorded. From these data, differences in the prevalence rates can be calculated for different time periods. The questionnaire will also include the Gotland Male Depression Scale as an instrument to assess male-specific symptomatology. In addition, potential moderating factors are considered using various instruments (including Normative Gender Role Orientation Questionnaire, Social Support Questionnaire), and self-constructed items (including the child's and mother's perceived health status), and their moderating impact will be examined. Potential influencing factors include, for example, the presence of an earlier depressive episode, demographic factors such as age, marital status immigrant background, normative gender role orientation, maternal and child health status, and circumstances of pregnancy / childbirth and childcare. Furthermore, the questionnaire also covers the medical and psychosocial care situation and the use of obstetric arrangements by fathers with depressive syndromes. To record the medical and psychosocial care, the young fathers indicate which services they have used in general and regarding to mental health problems during gestation and since the baby was born (based on scales of the Health Questionnaire of the adult health survey in Germany (DEGS), the German version of the Client Sociodemographic and Service Receipt Inventory (CSSRI-D) and the questionnaire for the collection of aged care (FIMA)). Based on the prevalence of depressive syndromes and information about care options, the rate of the young fathers which would use a specific treatment can be calculated. The standard contacts with medical and psychosocial services during pregnancy and afterwards (e.g. general practitioner, midwife as part of the aftercare, birth preparation courses), could be used to identify low-threshold access routes to an adequate care and possibly show important switching points for the implementation of preventive measures or for early interventions in men who are currently under-served.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013339
  •   2018/08/20
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  •   yes
  •   Approved
  •   551/17, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1218-8185 
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Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
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Interventions/Observational Groups

  •   Subjects are fathers of newborn children from the regions of Freiburg and Mannheim, who have become fathers of a child within the last 12 months prior to the survey. The contact details are expected to be received in mid-September 2018 through the registration offices. Immediately following the sampling, an anonymous questionnaire will be sent to the subjects to assess the prevalence of depressive syndromes (measured by the PHQ-9), other symptoms, risk factors and health care use.
  •   Subjects are men without childbirth within the last twelve months from the regions Freiburg and Mannheim matched by age, nationality and marital status to the fathers (see arm 1). The contact details are expected to be received in mid-September 2018 through the registration offices. Immediately following the sampling, an anonymous questionnaire will be sent to the subjects to assess the prevalence of depressive syndromes (measured by the PHQ-9), other symptoms, risk factors and health care use.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Screening
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

prevalence of depressive syndromes in fathers in the first year after the childbirth, compared to men of the same age without paternity (Patient-Health-Questionnaire-9; PHQ-9)

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Secondary Outcome

prevalence differences for different time periods; male-specific depressive symptomatology (Gotland Scale for Male Depression ); moderating factors (course of the disease, anxiety symptoms: ASA-27 & ASI, subjective estimation of the child's health status, subjective estimation of the mother’s health status, normative gender role orientation: NGRO, social support: F-SozU-K-14, aspects of pregnancy/ birth, involvement of the father, perceived self-efficacy: GSE, socio-demographic data, social class affiliation); and the current health care situation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • other 
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Recruitment

  •   Planned
  •   2018/09/10
  •   2300
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

The epidemiological cross-sectional study includes fathers of newborn children from the region of Freiburg and Mannheim who have become fathers of a child within the last 12 months prior to the survey. The "comparative sample" in this study is a control group of men without childbirth within the last twelve months matched by age, nationality and marital status.

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Exclusion Criteria

Due to the nature of the survey, however, persons with inadequate knowledge of the German language are excluded.

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Addresses

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    • Universitätsklinikum Freiburg Klinik für Psychiatrie und Psychotherapie AG Psychotherapie- und Versorgungsforschung
    • Mr.  Dr. phil.  Fabian  Frank 
    • Hauptstraße 5
    • 79104  Freiburg im Breisgau
    • Germany
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    • Universitätsklinikum Freiburg Klinik für Psychiatrie und Psychotherapie AG Psychotherapie- und Versorgungsforschung
    • Ms.  Julia  Albicker 
    • Hauptstraße 5
    • 79104  Freiburg im Breisgau
    • Germany
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    • Universitätsklinikum Freiburg Klinik für Psychiatrie und Psychotherapie AG Psychotherapie- und Versorgungsforschung
    • Ms.  Julia  Albicker 
    • Hauptstraße 5
    • 79104  Freiburg im Breisgau
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg, Klinik für Psychiatrie und Psychotherapie, AG Psychotherapie- und Versorgungsforschung
    • Mr.  Dr.  Fabian  Frank 
    • Hauptstraße 5
    • 79104  Freiburg
    • Germany
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    • Ministerium für Wissenschaft, Forschung und Kunst Baden-Württemberg
    • Königstraße 46
    • 70173  Stuttgart
    • Germany
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    • Wissenschaftliche Gesellschaft in Freiburg im Breisgau
    • Löwenstraße 16
    • 79098  Freiburg im Breisgau
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

  •   Positives Ethikvotum
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