Integration of Refugees Into Public Mental Health Care (INT_REF_MH)

Integration of Refugees With Mental Disorders Into the Public Psychotherapeutic Health Care Services - a Model Project With Trained Peers

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.

Study Overview

• Status: Recruiting
• Conditions: Psychiatric Disorders From Chapters 3 and 4 of ICD10
• Intervention / Treatment: Other: "coordinated and peer supported mental health care"; Behavioral: "standard psychotherapeutic care in the public healthcare system"

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Konstanz, Germany, 78464
    • Recruiting
    • University of Konstanz, Psychotherapy Outpatient Clinic
    • Contact: Michael Odenwald, PhD; Phone Number: +49 7531 884621; Email: michael.odenwald@uni-konstanz.de
    • Contact: Anne Schawohl, MA; Phone Number: +49 7531 883589; Email: anne.schawohl@uni-konstanz.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard psychotherapeutic care + coordinated and peer supported mental health care"; 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.	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.
Other: Standard psychotherapeutic care"; 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.	Behavioral: "standard psychotherapeutic care in the public healthcare system"; Psychotherapeutic services that are financed by the public health insurance system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Service utilisation	Percentage of participants who utilise psychotherapeutic services	6 months after study inclusion
Psychiatric symptom change	Self-report of psychiatric symptoms by means of questionnaires	assessments 6 and 12 months after study inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage correctly identified refugees with mental health problems	Comparison of peer screening and expert diagnostic assessment	two weeks

Collaborators and Investigators

• Sponsor: University of Konstanz
• Collaborators: Vivo international e.V.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior; Mental Disorders; Psychotropic Drugs
• Other Study ID Numbers: Refugee Integration 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No