NCT04185896

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
Last Updated

December 4, 2019

Status Verified

December 1, 2019

Enrollment Period

8 months

First QC Date

November 19, 2019

Last Update Submit

December 3, 2019

Conditions

Keywords

Social stigmaAccess to careFacilitatorsBarriers

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Sociodemographic data of participating affected PMD patients

    2019-2020

  • Sociodemographic data of participating health care professionals

    2019-2020

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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).
  • Sample 2: Professional health and social care providers
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anke Berger

Bern, 3008, Switzerland

RECRUITING

Related Publications (2)

  • 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.

    PMID: 28322424BACKGROUND
  • 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.

MeSH Terms

Conditions

Mental DisordersDepressionAnxiety DisordersPanic DisorderStress Disorders, Post-TraumaticSubstance-Related DisordersPsychotic DisordersPatient Acceptance of Health CareSocial Stigma

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersChemically-Induced DisordersSchizophrenia Spectrum and Other Psychotic DisordersTreatment Adherence and ComplianceHealth BehaviorSocial Behavior

Central Study Contacts

Anke Berger, Dr.

CONTACT

Eva Cignacco, Prof. Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project leader

Study Record Dates

First Submitted

November 19, 2019

First Posted

December 4, 2019

Study Start

July 10, 2019

Primary Completion

February 29, 2020

Study Completion

February 29, 2020

Last Updated

December 4, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

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.

Locations