NCT04832035

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.

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

April 9, 2021

Status Verified

April 1, 2021

Enrollment Period

2.8 years

First QC Date

April 1, 2021

Last Update Submit

April 6, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Percentage correctly identified refugees with mental health problems

    two weeks

Study Arms (2)

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

EXPERIMENTAL

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"Behavioral: "standard psychotherapeutic care in the public healthcare system"

Standard psychotherapeutic care"

OTHER

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"

Interventions

Health services, coordination of services, method to support utilization

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

Psychotherapeutic services that are financed by the public health insurance system.

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Mental disorder that requires inpatient treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Konstanz, Psychotherapy Outpatient Clinic

Konstanz, 78464, Germany

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CEO psychotherapeutic outpatient clinic, leading psychologist research ward

Study Record Dates

First Submitted

April 1, 2021

First Posted

April 5, 2021

Study Start

April 1, 2021

Primary Completion

December 31, 2023

Study Completion

June 30, 2024

Last Updated

April 9, 2021

Record last verified: 2021-04

Locations