Trial document




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  DRKS00016412

Trial Description

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Title

Multi-Center Effectiveness Study of Inpatient Psychosomatic-Psychotherapeutic Treatment in German University Hospitals

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Trial Acronym

MEPP Study

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URL of the Trial

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Brief Summary in Lay Language

This study evaluates the effectiveness of inpatient and day-/night-care treatment of people with psychic and psychosomatic disorders. Treatment will be delivered at 22 German university clinics of psychosomatics and psychotherapy for ca. 8-12 weeks. A sample of 2,200-3,000 patients will be assessed before and after treatment as well as one year after treatment. Outcome criteria are symptoms of disease, problems in everyday life, and mental health care utilization.

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Brief Summary in Scientific Language

The efficacy of psychotherapy for a wide range of psychic and psychosomatic disorders is indisputable and well-validated. However, most efficacy studies have been undertaken in highly selected patients and an outpatient setting. Data of the effectiveness of inpatient treatment are comparably sparse and from smaller studies. This multicenter cohort study aims to assess the effectiveness of inpatient and day-/nightcare treatment in 22 German university clinics of psychosomatic medicine and psychotherapy in a large sample of 2,200-3,000 patients. After informed consent has been obtained from the patients, assessments will be performed at the beginning and end of the treatment as well as a one-year follow-up. Assessments will employ questionnaires focusing symptom load, social functioning, and mental health care service use. Baseline diagnoses are made by standardized structured interviews.

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Organizational Data

  •   DRKS00016412
  •   2018/12/20
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  •   yes
  •   Approved
  •   18-6388, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

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Health Condition or Problem studied

  •   All disorders that are being treated at the clinics for psychosomatic medicine and psychotherapy (primarily ICD-10: F3, F4, F5, F6).
  •   F30-F39 -  Mood [affective] disorders
  •   F40 -  Phobic anxiety disorders
  •   F50-F59 -  Behavioural syndromes associated with physiological disturbances and physical factors
  •   F60-F69 -  Disorders of adult personality and behaviour
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Interventions/Observational Groups

  •   Inpatient or day-/nightcare treatment for ca. 8-12 weeks in university clinics of psychosomatic medicine and psychotherapy. These treatments combine different compounds, e.g., individual psychotherapy, group psychotherapy, non-verbal psychotherapeutic therapies.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Symptom load (anxiety, depression, somatic symptoms) as assessed by th PHQ-D at the end of the treatment and one-year follow-up.

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Secondary Outcome

Social functioning (WHODAS 2.0), personality structure (OPD-SF), mental health care service utilization (modified version of the CSSRI) at the end of the treatment and one-year follow-up.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Planned
  •   2019/03/01
  •   2200
  •   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

Age ≥ 18 years, sufficient knowledge of German language, admission for inpatient or day-/nightcare treatment in clinic for psychosomatics and psychotherapy

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Exclusion Criteria

Acute psychotic disorder, brain organic disease, substance dependency with current substance use and intoxication

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Addresses

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    • Klinik für Psychosomatische Medizin und Psychotherapie Ruhr Universität Bochum
    • Mr.  Prof. Dr.  Stephan  Herpertz 
    • Alexandrinenstraße 1-3
    • 44791  Bochum
    • Germany
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    • Klinik für Psychoanalyse und Psychotherapie Medizinische Universität Wien
    • Mr.  Prof. Dr.  Stephan  Doering 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Austria
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    • Klinik für Psychoanalyse und Psychotherapie Medizinische Universität Wien
    • Mr.  Prof. Dr.  Stephan  Doering 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Austria
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Sources of Monetary or Material Support

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    • Medizinische Klinik mit Schwerpunkt Psychosomatik
    • Mr.  Prof. Dr.  Matthias  Rose 
    • Hindenburgdamm 30
    • 12200  Berlin
    • Germany
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    • Klinik für Psychosomatische Medizin und Psychotherapie Ruhr Universität Bochum
    • Mr.  Prof. Dr.  Stephan  Herpertz 
    • Alexandrinenstraße 1-3
    • 44791  Bochum
    • Germany
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    • Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie Universitätsklinikum Bonn
    • Ms.  Prof. Dr.  Franziska  Geiser 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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    • Klinik und Poliklinik für Psychotherapie und Psychosomatik Carl Gustav Carus Universität Dresden
    • Ms.  Prof. Dr.  Kerstin  Weidner 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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    • Klinik für Psychosomatische Medizin und Psychotherapie LVR-Klinikum Düsseldorf
    • Mr.  Dr.  Jörg  Rademacher 
    • Bergische Landstraße 2
    • 40629  Düsseldorf
    • Germany
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    • Psychosomatische und Psychotherapeutische Abteilung Universitätsklinikum Erlangen
    • Ms.  Prof. Dr.  Yesim  Erim 
    • Schwabachanlage 6
    • 91054  Erlangen
    • Germany
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    • Klinik für Psychosomatische Medizin und Psychotherapie LVR-Klinikum Essen
    • Mr.  Prof. Dr.  Martin  Teufel 
    • Virchowstr. 174
    • 45147  Essen
    • Germany
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    • Klinik für Psychosomatische Medizin und Psychotherapie Universitätsklinikum Freiburg
    • Mr.  Prof. Dr.  Claas  Lahmann 
    • Hauptstraße 8
    • 79104  Freiburg
    • Germany
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    • Klinik für Psychosomatische Medizin und Psychotherapie Universitätsmedizin Göttingen
    • Mr.  Prof. Dr.  Christoph  Herrmann-Lingen 
    • Von-Siebold-Str. 5
    • 37075  Göttingen
    • Germany
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    • Klinik für Psychosomatik und Psychotherapie Medizinische Hochschule Hannover
    • Ms.  Prof. Dr.  Martina  de Zwaan 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Klinik für Allgemeine Innere Medizin und Psychosomatik Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr.  Hans-Christoph  Friederich 
    • Im Neuenheimer Feld 410
    • 69120  Heidelberg
    • Germany
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    • Klinik und Poliklinik für Psychosomatik und Psychotherapie Uniklinik Köln
    • Mr.  Prof. Dr.  Christian  Albus 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie Universitätsklinikum Leipzig
    • Ms.  Prof. Dr.  Anette  Kersting 
    • Semmelweisstraße 10
    • 04103  Leipzig
    • Germany
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    • Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie Universitätsmedizin Mainz
    • Mr.  Prof. Dr.  Manfred E.  Beutel 
    • Untere Zahlbacher Str. 8
    • 55131  Mainz
    • Germany
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    • Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie Klinikum Rechts der Isar TU München
    • Mr.  Prof. Dr.  Peter  Henningsen 
    • Langerstraße 3
    • 81675  München
    • Germany
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    • Klinik für Psychosomatik und Psychotherapie Universitätsklinikum Münster
    • Mr.  Prof. Dr.  Gereon  Heuft 
    • Domagkstraße 22
    • 48149  Münster
    • Germany
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    • Klinik für Psychosomatische Medizin und Psychotherapie Universitätsklinik der Paracelsus Medizinischen Privatuniversität
    • Ms.  Prof. Dr.  Christiane  Waller 
    • Prof.-Ernst-Nathan-Str. 1
    • 90419  Nürnberg
    • Germany
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    • Psychosomatische Medizin und Psychotherapie Universitätsklinikum Ulm
    • Mr.  Prof. Dr.  Harald  Gündel 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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    • Klinik für Psychosomatik und Psychotherapie Universitätsklinikum Gießen/Marburg
    • Mr.  Prof. Dr.  Johannes  Kruse 
    • Friedrichstr. 33
    • 35392  Gießen
    • Germany
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    • Abteilung für Psychosomatische Medizin Universitätsklinikum Regensburg
    • Mr.  Prof. Dr.  Thomas  Loew 
    • Franz-Josef-Strauß-Allee 11
    • 93053  Regensburg
    • Germany
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    • Klinik für Psychosomatik und Psychotherapeutische Medizin Universitätsmedizin Rostock
    • Mr.  Dr.  Karsten  Hake 
    • Gehlsheimer Str. 20
    • 18147  Rostock
    • Germany
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    • Medizinische Klinik Psychosomatische Medizin und Psychotherapie Universitätsklinikum Tübingen
    • Mr.  Prof. Dr.  Stephan  Zipfel 
    • Osianderstraße 5
    • 72076  Tübingen
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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