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Integration of Refugees Into Public Mental Health Care (INT_REF_MH)

Primary Purpose

Psychiatric Disorders From Chapters 3 and 4 of ICD10

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
"coordinated and peer supported mental health care"
"standard psychotherapeutic care in the public healthcare system"
Sponsored by
University of Konstanz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Psychiatric Disorders From Chapters 3 and 4 of ICD10

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Konstanz, Psychotherapy Outpatient ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Standard psychotherapeutic care + coordinated and peer supported mental health care"

Standard psychotherapeutic care"

Arm Description

Participants receive standard psychotherapeutic care in the public healthcare system. For participants and therapists in this group standard care and additional organisational support is available which is labeled "coordinated and peer supported mental health care". This includes several additional organisational assistance components that are currently not part of the services of the public mental health care system, i.e. a coordination center, trained peers to support treatment utilisation, a support and training center for therapists, and an interpreter pool.This is Treatment as Usual plus coordination and peer support.

Participants receive standard psychotherapeutic care in the public healthcare system. For participants in this group no additional organisational support is available. This is Treatment as Usual.

Outcomes

Primary Outcome Measures

Service utilisation
Percentage of participants who utilise psychotherapeutic services
Psychiatric symptom change
Self-report of psychiatric symptoms by means of questionnaires

Secondary Outcome Measures

Percentage correctly identified refugees with mental health problems
Comparison of peer screening and expert diagnostic assessment

Full Information

First Posted
April 1, 2021
Last Updated
April 6, 2021
Sponsor
University of Konstanz
Collaborators
Vivo international e.V.
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1. Study Identification

Unique Protocol Identification Number
NCT04832035
Brief Title
Integration of Refugees Into Public Mental Health Care
Acronym
INT_REF_MH
Official Title
Integration of Refugees With Mental Disorders Into the Public Psychotherapeutic Health Care Services - a Model Project With Trained Peers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz
Collaborators
Vivo international e.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Disorders From Chapters 3 and 4 of ICD10

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard psychotherapeutic care + coordinated and peer supported mental health care"
Arm Type
Experimental
Arm Description
Participants receive standard psychotherapeutic care in the public healthcare system. For participants and therapists in this group standard care and additional organisational support is available which is labeled "coordinated and peer supported mental health care". This includes several additional organisational assistance components that are currently not part of the services of the public mental health care system, i.e. a coordination center, trained peers to support treatment utilisation, a support and training center for therapists, and an interpreter pool.This is Treatment as Usual plus coordination and peer support.
Arm Title
Standard psychotherapeutic care"
Arm Type
Other
Arm Description
Participants receive standard psychotherapeutic care in the public healthcare system. For participants in this group no additional organisational support is available. This is Treatment as Usual.
Intervention Type
Other
Intervention Name(s)
"coordinated and peer supported mental health care"
Intervention Description
Health services, coordination of services, method to support utilization
Intervention Type
Behavioral
Intervention Name(s)
"standard psychotherapeutic care in the public healthcare system"
Intervention Description
Psychotherapeutic services that are financed by the public health insurance system.
Primary Outcome Measure Information:
Title
Service utilisation
Description
Percentage of participants who utilise psychotherapeutic services
Time Frame
6 months after study inclusion
Title
Psychiatric symptom change
Description
Self-report of psychiatric symptoms by means of questionnaires
Time Frame
assessments 6 and 12 months after study inclusion
Secondary Outcome Measure Information:
Title
Percentage correctly identified refugees with mental health problems
Description
Comparison of peer screening and expert diagnostic assessment
Time Frame
two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Konstanz, Psychotherapy Outpatient Clinic
City
Konstanz
ZIP/Postal Code
78464
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Odenwald, PhD
Phone
+49 7531 884621
Email
michael.odenwald@uni-konstanz.de
First Name & Middle Initial & Last Name & Degree
Anne Schawohl, MA
Phone
+49 7531 883589
Email
anne.schawohl@uni-konstanz.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Integration of Refugees Into Public Mental Health Care

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