Mental DisorderMADRENCT04185896
Perinatal Mental Health Care in Switzerland
An observational study of Mental Disorder and Perinatal, run by Bern University of Applied Sciences at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder, Perinatal, Depression
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Jul 2019to 29 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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):
Show all 13Show fewer
- 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).
- 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.
Who cannot join
- Sample 2: Professional health and social care providers
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Anke Berger
Bern, 3008
Anke Berger, Dr., +41318483543, anke.berger@bfh.ch
Eva Cignacco, Prof. Dr., +41 31 848 45 18, eva.cignacco@bfh.ch
About this study
Official title: 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.
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.
- Conditions
- Mental Disorder, Perinatal, Depression, Anxiety Disorders, Panic Disorder, Post Traumatic Stress Disorder
- Keywords
- Social stigma, Access to care, Facilitators, Barriers
- Medical subject headings
- Mental Disorders, Depression, Anxiety Disorders, Panic Disorder, Stress Disorders, Post-Traumatic, Substance-Related Disorders, Psychotic Disorders, Patient Acceptance of Health Care
What is being measured
The primary outcome is the main question the study is designed to answer.
Narratives of barriers to perinatal mental health care use
Narratives of access-inhibiting factors, in semi-structured individual interviews with former PMD patients
Measured: perinatal phase, i.e. pregnancy and first year after birth
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
Measured: Perinatal phase, i.e. pregnancy and first year after birth
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
Measured: Perinatal phase, i.e. pregnancy and first year after birth
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
Measured: Perinatal phase, i.e. pregnancy and first year after birth
Secondary outcomes (2)
Sociodemographic data of participating affected PMD patients
Sociodemographic data of participating affected PMD patients
Measured: 2019-2020
Sociodemographic data of participating health care professionals
Sociodemographic data of participating health care professionals
Measured: 2019-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start10 Jul 2019
- Primary completion29 Feb 2020 (estimated)
- Study completion29 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bern University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Principal investigator, Anke Berger, Bern University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185896
- Sponsor's protocol ID
- 2218-2018
- Acronym
- MADRE
- Status last verified
- Dec 2019
- First submitted
- 19 Nov 2019
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 28322424Berger 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perinatal Mental Health Care in Switzerland: Unraveling the Perspectives of Affected Women and Health Professionals
- ClinicalTrials.gov ID
- NCT04185896
- Acronym / sponsor ID
- MADRE / 2218-2018
- Conditions
- Mental Disorder, Perinatal, Depression, Anxiety Disorders, Panic Disorder, Post Traumatic Stress Disorder
- Keywords
- Social stigma, Access to care, Facilitators, Barriers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Bern University of Applied SciencesUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 29 Feb 2020 (estimated)
- Study completion
- 29 Feb 2020 (estimated)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (1 listed)
- Sample 2: Professional health and social care providers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
2 secondary outcomes
Sociodemographic data of participating affected PMD patients
Time frame: 2019-2020
Sociodemographic data of participating health care professionals
Time frame: 2019-2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Background: PubMed 28322424Berger 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.
- Derived from this study: PubMed 32066475Berger 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Disorder and Perinatal, run by Bern University of Applied Sciences at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anke Berger, Dr. (+41318483543, anke.berger@bfh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Narratives of barriers to perinatal mental health care use (time frame: perinatal phase, i.e. pregnancy and first year after birth). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04185896, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2019.