Perinatal Mental Health Care in Switzerland (MADRE)

December 3, 2019 updated by: Anke Berger, Bern University of Applied Sciences

Perinatal Mental Health Care in Switzerland: Unraveling the Perspectives of Affected Women and Health Professionals

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.

Study Overview

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.

Study Type

Observational

Enrollment (Anticipated)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Narratives of barriers to perinatal mental health care use
Time Frame: perinatal phase, i.e. pregnancy and first year after birth
Narratives of access-inhibiting factors, in semi-structured individual interviews with former PMD patients
perinatal phase, i.e. pregnancy and first year after birth
Narratives of mentions of facilitators of perinatal mental health care use
Time Frame: Perinatal phase, i.e. pregnancy and first year after birth
Narratives of access-promoting factors, in semi-structured individual interviews with former PMD patients
Perinatal phase, i.e. pregnancy and first year after birth
Narratives of mentions of barriers to perinatal mental health care provision
Time Frame: Perinatal phase, i.e. pregnancy and first year after birth
Narratives of provision-inhibiting factors, in focus group interviews with health and social care providers
Perinatal phase, i.e. pregnancy and first year after birth
Narratives of mentions of facilitators of perinatal mental health care provision
Time Frame: Perinatal phase, i.e. pregnancy and first year after birth
Narratives of provision-promoting factors, in focus group interviews with health and social care providers
Perinatal phase, i.e. pregnancy and first year after birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic data of participating affected PMD patients
Time Frame: 2019-2020
Sociodemographic data of participating affected PMD patients
2019-2020
Sociodemographic data of participating health care professionals
Time Frame: 2019-2020
Sociodemographic data of participating health care professionals
2019-2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 10, 2019

Primary Completion (ANTICIPATED)

February 29, 2020

Study Completion (ANTICIPATED)

February 29, 2020

Study Registration Dates

First Submitted

November 19, 2019

First Submitted That Met QC Criteria

December 3, 2019

First Posted (ACTUAL)

December 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 4, 2019

Last Update Submitted That Met QC Criteria

December 3, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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