CClinicalTrials.gg
Status unknownNCT04185896MADREUpdated Dec 4, 2019

Perinatal Mental Health Care in Switzerland

An observational study in Mental Disorder, Perinatal and Depression, sponsored by Bern University of Applied Sciences. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-04.

Sponsored by Bern University of Applied Sciences · Observational

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
24
Ages
18 Years and older
Sex
All
01

Study summary

This qualitative study with quantitative elements examines the health care provided to women who suffered from mental disorder during pregnancy and / or in the first year after birth (i.e. during the perinatal phase). Investigators will perform individual interviews with former PMD patients, and health and social care professionals to gain insights into current health care for PMD patients.

Read the detailed description

Background: Perinatal mental disorders (PMD) are highly prevalent (up to 20%), and patients use mental health care at high rates (Berger et al 2018). It is not known if the health care for PMD patients meets the needs of the patients.

Aim: The Investigators will identify factors that promote or hinder service provision and access to care, for a range of relevant PMD. The investigation will cover the user and provider perspectives.

Methods: The qualitative study consists of two complementary parts to assess user and provider perspectives. In part 1 the Investigators will conduct individual semi-structured interviews with 24 women who have had PMD. The sample will comprise of 4 clusters of relevant ICD-10 F-diagnoses, covering a wide range of mental disorders. The sample will also comprise of participants who received or did not receive mental health care before the last pregnancy. In part 2, the Investigators perform 3 focus groups (with 6-8 participants per group) with health and social care professionals, and a health-insurance delegate, to collect their experiences and perspectives on perinatal health care for PMD patients. The Investigators are guided for data collection and analysis by Levesque's et al (2013) conceptual model on access to health care.

Expected results: The study will identify barriers and facilitators for health care access (user perspective) and provision (provider perspective). The study will generate the evidence base needed to develop integrated, coordinated, patient- and family-centered care for patients with various types of PMD.

02

Conditions studied

  • Mental Disorder
  • Perinatal
  • Depression
  • Anxiety Disorders
  • Panic Disorder
  • Post Traumatic Stress Disorder
  • Adaptation Reaction
  • Behavior Disorders
  • Substance Abuse
  • Psychosis
  • Health Care Seeking Behavior
  • Health Care Utilization
  • Health Care Acceptability

Keywords

  • Social stigma
  • Access to care
  • Facilitators
  • Barriers
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Population 1: 24 former PMD patients, by 4 groups of F-diagnoses (ICD-10) and 2 groups (yes or no) of pre-existent mental disorders.

Population 2: 18-24 professional health care and social care providers, who are experienced in service provision for PMD patients and are

  • Nurses
  • Midwives
  • Gynecologists
  • Medical primary care providers
  • Pediatricians
  • Neonatologists
  • Psychiatrists
  • Psychologists
  • Social care providers (community service)
  • Expert from a health insurance

Eligibility criteria

Sample 1: patients with former PMD

Inclusion criteria:

  1. PMD within the past 24 months before the interview,
  2. Recovered from acute PMD and stable for at least 12 months before the interview;
  3. Able to share experiences;
  4. More than 18 years old
  5. Speak and understand German
  6. At least 1 diagnosis in the last perinatal phase out of 4 groups of psychiatric disorders (ICD-10 Chapter V, F00-F99):

    1. Mood (affective) disorders (F30-F39); Anxiety disorders (F41); Reaction to severe stress, and adjustment disorders (F43); and Obsessive-compulsive disorder (F42);
    2. Disorders of adult personality and behavior (F60-F69; especially F60.3 Emotionally unstable personality disorder);
    3. Mental and behavioral disorders due to psychoactive substance use (F10-F19; excluding tobacco (F17) if it is the sole F-diagnosis of the patient);
    4. Psychosis (F20-F29 Schizophrenia, schizotypal and delusional disorders).

Exclusion criterion: Current pregnancy

Sample 2: Professional health and social care providers

Inclusion criteria:

  1. Professional experience of at least two years,
  2. Have cared for at least 2 PMD patients the year before the focus group, a
  3. Speak and understand German.
04

Study design

Observational model
Other
Time perspective
Other
Enrollment
24 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Narratives of barriers to perinatal mental health care use

    Narratives of access-inhibiting factors, in semi-structured individual interviews with former PMD patients

    Time frame: perinatal phase, i.e. pregnancy and first year after birth

  2. Narratives of mentions of facilitators of perinatal mental health care use

    Narratives of access-promoting factors, in semi-structured individual interviews with former PMD patients

    Time frame: Perinatal phase, i.e. pregnancy and first year after birth

  3. Narratives of mentions of barriers to perinatal mental health care provision

    Narratives of provision-inhibiting factors, in focus group interviews with health and social care providers

    Time frame: Perinatal phase, i.e. pregnancy and first year after birth

  4. Narratives of mentions of facilitators of perinatal mental health care provision

    Narratives of provision-promoting factors, in focus group interviews with health and social care providers

    Time frame: Perinatal phase, i.e. pregnancy and first year after birth

Secondary outcomes

  1. Sociodemographic data of participating affected PMD patients

    Sociodemographic data of participating affected PMD patients

    Time frame: 2019-2020

  2. Sociodemographic data of participating health care professionals

    Sociodemographic data of participating health care professionals

    Time frame: 2019-2020

06

Study locations

1 of 1 sites recruiting
  • Anke Berger
    Bern, 3008, Switzerland
    Recruiting
07

References and documents

Publications

  • Berger A, Bachmann N, Signorell A, Erdin R, Oelhafen S, Reich O, Cignacco E. Perinatal mental disorders in Switzerland: prevalence estimates and use of mental-health services. Swiss Med Wkly. 2017 Mar 7;147:w14417. doi: 10.4414/smw.2017.14417. eCollection 2017. PubMed 28322424 ↗
  • Berger A, Schenk K, Ging A, Walther S, Cignacco E. Perinatal mental health care from the user and provider perspective: protocol for a qualitative study in Switzerland. Reprod Health. 2020 Feb 17;17(1):26. doi: 10.1186/s12978-020-0882-7. PubMed 32066475 ↗

Individual participant data

Plan to share: No — The Ethics Committee does not allow sharing of patients' data. The Ethics Committee allows and the Investigators are willing to share the data collected from health and social care professionals upon publication of the study.

08

Registry details

Key details

Study ID
NCT04185896
Lead sponsor
Bern University of Applied Sciences
Collaborators
University of Bern
Responsible party
Anke Berger (Project leader, Bern University of Applied Sciences) — Principal investigator
First posted
Dec 4, 2019
Start date
Jul 10, 2019
Primary completion
Feb 29, 2020 (estimated)
Completion
Feb 29, 2020 (estimated)
Last update
Dec 4, 2019

Study contacts

Anke Berger, Dr.
Contact
anke.berger@bfh.ch
+41318483543
Eva Cignacco, Prof. Dr.
Contact
eva.cignacco@bfh.ch
+41 31 848 45 18

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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