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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04832035
Other study ID # Refugee Integration 2021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date June 30, 2024

Study information

Verified date April 2021
Source University of Konstanz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There are specific barriers to utilise psychotherapeutic services for refugees with mental health problems in the German public health care system. This study aims to evaluate additional organisational components that are hypothesised to improve service utilisation. In a randomised controlled trial, refugees with mental health problems are identified by peers, subsequently assessed by professional staff and referred to public psychotherapeutic health services who offer standard care. Participants are assigned to care as usual or to "coordinated and peer supported mental health care"; the latter includes several additional organisational assistance components, i.e. a coordination center, trained peers to support treatment utilisation, a support and training center for therapists, and a interpreter pool. Measures include service utilisation and symptom change after 6 months. Furthermore the study evaluates whether trained peers can correctly identify participants with mental health problems.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date June 30, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Psychiatric diagnosis from Chapters 3 and 4 of ICD10 - Participant applied for asylum in Germany - Entry to Germany after 2012 - Participants is motivated to utilise psychotherapeutic services - Patient speaks one of the languages in which services are offered (i.e. German, English, French, Arabic, Kurdish, Dari, Farsi, Urdu, Pashto, Tirginya, Somali) Exclusion Criteria: - Mental disorder that requires inpatient treatment

Study Design


Related Conditions & MeSH terms


Intervention

Other:
"coordinated and peer supported mental health care"
Health services, coordination of services, method to support utilization
Behavioral:
"standard psychotherapeutic care in the public healthcare system"
Psychotherapeutic services that are financed by the public health insurance system.

Locations

Country Name City State
Germany University of Konstanz, Psychotherapy Outpatient Clinic Konstanz

Sponsors (2)

Lead Sponsor Collaborator
University of Konstanz Vivo international e.V.

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Service utilisation Percentage of participants who utilise psychotherapeutic services 6 months after study inclusion
Primary Psychiatric symptom change Self-report of psychiatric symptoms by means of questionnaires assessments 6 and 12 months after study inclusion
Secondary Percentage correctly identified refugees with mental health problems Comparison of peer screening and expert diagnostic assessment two weeks