- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04185896
Perinatal Mental Health Care in Switzerland (MADRE)
Perinatal Mental Health Care in Switzerland: Unraveling the Perspectives of Affected Women and Health Professionals
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Anke Berger, Dr.
- Phone Number: +41318483543
- Email: anke.berger@bfh.ch
Study Contact Backup
- Name: Eva Cignacco, Prof. Dr.
- Phone Number: +41 31 848 45 18
- Email: eva.cignacco@bfh.ch
Study Locations
-
-
-
Bern, Switzerland, 3008
- Recruiting
- Anke Berger
-
Contact:
- Anke Berger, Dr.
- Phone Number: +41318483543
- Email: anke.berger@bfh.ch
-
Contact:
- Eva Cignacco, Prof. Dr.
- Phone Number: +41 31 848 45 18
- Email: eva.cignacco@bfh.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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:
- PMD within the past 24 months before the interview,
- Recovered from acute PMD and stable for at least 12 months before the interview;
- Able to share experiences;
- More than 18 years old
- Speak and understand German
At least 1 diagnosis in the last perinatal phase out of 4 groups of psychiatric disorders (ICD-10 Chapter V, F00-F99):
- Mood (affective) disorders (F30-F39); Anxiety disorders (F41); Reaction to severe stress, and adjustment disorders (F43); and Obsessive-compulsive disorder (F42);
- Disorders of adult personality and behavior (F60-F69; especially F60.3 Emotionally unstable personality disorder);
- Mental and behavioral disorders due to psychoactive substance use (F10-F19; excluding tobacco (F17) if it is the sole F-diagnosis of the patient);
- Psychosis (F20-F29 Schizophrenia, schizotypal and delusional disorders).
Exclusion criterion: Current pregnancy
Sample 2: Professional health and social care providers
Inclusion criteria:
- Professional experience of at least two years,
- Have cared for at least 2 PMD patients the year before the focus group, a
- Speak and understand German.
Study Plan
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
Collaborators
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2218-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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