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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04185896
Other study ID # 2218-2018
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 10, 2019
Est. completion date February 29, 2020

Study information

Verified date December 2019
Source Bern University of Applied Sciences
Contact Anke Berger, Dr.
Phone +41318483543
Email anke.berger@bfh.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date February 29, 2020
Est. primary completion date February 29, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
Switzerland Anke Berger Bern

Sponsors (2)

Lead Sponsor Collaborator
Bern University of Applied Sciences University of Bern

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Narratives of barriers to perinatal mental health care use Narratives of access-inhibiting factors, in semi-structured individual interviews with former PMD patients perinatal phase, i.e. pregnancy and first year after birth
Primary 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 Perinatal phase, i.e. pregnancy and first year after birth
Primary 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 Perinatal phase, i.e. pregnancy and first year after birth
Primary 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 Perinatal phase, i.e. pregnancy and first year after birth
Secondary Sociodemographic data of participating affected PMD patients Sociodemographic data of participating affected PMD patients 2019-2020
Secondary Sociodemographic data of participating health care professionals Sociodemographic data of participating health care professionals 2019-2020
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