Trial document




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  DRKS00025972

Trial Description

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Title

Implementing a native-language app as a part of a blended care approach in inpatient psychiatric care for refugees

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Trial Acronym

I-REACH (Internet based REfugee mentAl healtH Care)

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URL of the Trial

https://www.gesundheitsforschung-bmbf.de/de/implementierungsstudie-8836.php

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Brief Summary in Lay Language

Refugees represent a large group in inpatient mental health care [Schaffrath et al., 2017]. However, there is a lack of treatment methods and support services specifically adapted to the needs and requirements of refugees. In particular, it would be desirable to support the communication process between patients and their therapists by using a native-language app in inpatient mental health care.

In this project, feasibility of a blended care approach (i.e., the combination of treatment as usual with a native-language app) in inpatient mental health care for refugees with mental illness is investigated. The research question is whether the app use is feasible and whether the app is used by patients during their stay in the psychiatric hospital. Furthermore, it will be examined whether the blended care approach offers advantages compared to treatment as usual.

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Brief Summary in Scientific Language

Refugees are at high risk for mental illness. Studies show that the prevalence of post-traumatic stress disorder (PTSD) among refugees is around 30% and that there is an equally high prevalence of depression [Lindert et al., 2017; Steel et al., 2009]. In inpatient mental health care, people with refugee experiences now represent a large affected group [Schaffrath et al., 2017]. However there is a lack of treatment methods and support services specifically adapted to the needs and requirements of refugees. In particular, it would be desirable to support the communication process between therapists and patients by providing low-threshold, culturally sensitive, and native-language internet based tools (e.g. a native-language app).

I-REACH is a cluster-randomized, prospective, controlled implementation research study lasting for two years. It examines the feasibility of implementing a "blended care approach" (i.e., combining treatment as usual with a native-language app ) in inpatient mental health care for refugees with mental illness. The research question is whether the app use during hospital stay is feasible and whether the app is used by study patients (implementation study). Furthermore, it will be examined whether the "blended care approach" offers advantages compared to treatment as usual without the use of a native-language app.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

When exporting data from the app to partners of the I-REACH consortium, no personally identifying data (usernames or contact data) are exported. Instead, each data set receives a randomly generated ID and is then pseudonymized. As part of the collaboration with the other four subprojects of the I-REACH consortium and existing cooperation agreements, following data are made available anonymously to the institutions (as mentioned below) participating in the research consortium project:

Institut für Gesundheitsökonomie und Versorgungsforschung, Universitätsklinikum
Hamburg-Eppendorf.
Projektleitung: Dr. Alexander Konnopka
Telefon +49-40-7410
E-Mail: a.konnopka@uke.de
Provided are: Anonymized data for socioeconomic analyses.


Abteilung Klinische Psychologie und Psychotherapie, Ludwig-Maximilians-Universität München.
Projektleitung: Prof. Dr. Thomas Ehring
Telefon +49-89-21805172
E-Mail: sekretariat.ehring@psy.lmu.de
Provided are: Anonymized data on sociodemographics, postmigration stressors, and reasons for dropout.

Due to data protection, data transfer to partners not involved in the I-REACH consortium is not planned.

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Organizational Data

  •   DRKS00025972
  •   2021/11/11
  •   [---]*
  •   yes
  •   Approved
  •   2021113, Ethikkommission der Ärztekammer Nordrhein
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
  •   F34 -  Persistent mood [affective] disorders
  •   F40 -  Phobic anxiety disorders
  •   F41 -  Other anxiety disorders
  •   F43 -  Reaction to severe stress, and adjustment disorders
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Interventions/Observational Groups

  •   Intervention arm: Blended Care ((Treatment as usual (TAU) + native-language app (blended CETA))
  •   Control arm: Treatment as usual (TAU)
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Characteristics

  •   Interventional
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  •   Other
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Use of a native-language app during the inpatient psychiatric-psychotherapeutic stay. The primary endpoint is collected using the generated app data.

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Secondary Outcome

Clinical variables, acceptability and usability of the intervention. Parameters will be assessed using routine data and information from interviews with refugees and therapeutic staff.

The following parameters will be collected from study patients:
- Sociodemographic questionnaire for patients of both groups (baseline)
- Client Statisfaction Questionnaire (CSQ-8) adapted version (only intervention group at discharge)
- Post Migration Living Difficulties Checklist (PMLD) for patients of both groups (baseline)
- Therapy Expectancy Questionnaire for patients in the intervention group (baseline)
- Health-related quality of life using EQ-5D-5L for patients in both groups (baseline, discharge, follow-up)
- Questionnaire on the use of services within the health care system for patients of both groups (baseline, follow-up).

The following instruments will be collected from participating therapists:
- Routine data (clinical global impression scale, global assessment of functioning, principal and secondary diagnosis(es), insurance status, date of admission and discharge of patients).
- Questionnaire on expectations of the blended care model and the app.
Questions about experiences with the blended care model and with the app

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2022/06/01
  •   290
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Refugees from Arabic- and Farsi-speaking countries, signed consent form, current inpatient treatment in one of the participating hospitals, need for mental health care due to depression (F32-F34), anxiety disorder (F40, F41), stress/trauma-associated disorders (F43).

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Exclusion Criteria

Health conditions that exclude the use of apps, acute suicidality, involuntary inpatient stays (according to a ruling by a judge based on the PsychKG-NRW or the BGB), lack of informed consent, lack of ability to use a smartphone, no sufficient knowledge of Arabic language or Farsi

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Addresses

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    • LVR-Institut für Forschung und Bildung, LVR-Institut für Versorgungsforschung, c/o LVR-Klinik Köln
    • Ms.  Professor Dr. med.  Euphrosyne  Gouzoulis-Mayfrank 
    • Wilhelm-Griesinger-Str. 23
    • 51109  Köln
    • Germany
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    • Freie Universität Berlin, Arbeitsbereich Klinisch-Psychologische Intervention
    • Ms.  Professor Dr.  Christine  Knaevelsrud 
    • Habelschwerdter Allee 45
    • 14195  Berlin
    • Germany
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    • Universität Leipzig, Abteilung für Medizinische Psychologie und Medizinische Soziologie
    • Ms.  Professor Dr.  Heide  Glaesmer 
    • Philipp-Rosenthal-Str. 55, Haus W
    • 04103  Leipzig
    • Germany
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    • MSB Medical School Berlin
    • Ms.  Professor Dr.  Birgit  Wagner 
    • Rüdesheimer Str. 50
    • 14197  Berlin
    • Germany
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    • Freie Universität Berlin, Klinische Psychologie und Psychotherapie
    • Ms.  Professor Dr.  Babette  Renneberg 
    • Habelschwerdter Allee 45
    • 14195  Berlin
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf, Institut für Gesundheitsökonomie und Versorgungsforschung
    • Mr.  Dr. med.  Alexander  Konnopka 
    • Martinistrasse 52
    • 20246  Hamburg
    • Germany
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    • LVR-Institut für Forschung und Bildung, LVR-Institut für Versorgungsforschung, c/o LVR-Klinik Köln
    • Ms.  Dr.  Isabelle  Reinhardt 
    • Wilhelm-Griesinger-Str. 23
    • 51109  Köln
    • Germany
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    • LVR-Institut für Forschung und Bildung, LVR-Institut für Versorgungsforschung, c/o LVR-Klinik Köln
    • Ms.  Laura  Schmidt 
    • Wilhelm-Griesinger-str. 23
    • 51109  Köln
    • Germany
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    •   02218993896
    •   [---]*
    •   ireach at lvr.de
    •   [---]*
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.