Trial document





This trial has been registered retrospectively.
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  DRKS00003396

Trial Description

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Title

Mentalisation based versus psychodynamic group therapy in a day hospital treatment

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Trial Acronym

MBGT

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URL of the Trial

http://-

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Brief Summary in Lay Language

Between 2003 and 2007 106 psychiatric, psychosomatic and psychotherapeutic day clinics have been founded. The number of cases has increased from 88214 by 37% up to 120433. However, there are not enough. It is not only necessary to establish further of such day clinics but also to choose an efficacious and effective psychotherapeutic concept of day clinics. For this aim the mentalization based group therapy (Bateman & Fonagy 2004, 2011; Schultz-Venrath 2008, 2011), a relatively young therapy method, is predestinated. The study examines the efficacy of mentalization based group therapy in contrast to the popular psychodynamic group therapy in a heterogeneous patient sample of a psychotherapeutic day clinic. Mentalization based group therapy has its focus on the improvement of the perception of the current emotions of the self and the others. The psychodynamic group psychotherapy concentrates on the ego training in action within a focus of unconscious interpersonal conflicts and symptoms (Mattke 2011). In our study, we will answer the question whether the mentalization based group therapy with a heterogeneous patient population will cause an improvement of mentalization and associated with this a higher reduction of mental impairment than the psychodynamic group psychotherapy. In the case of informed consense the patients will be allocated to the group of therapy with a free place. The treatment has an average duration of nine weeks. The efficacy of the treatment is assessed by the patients, the therapists and the experts with different methods to evaluate the severity of symptoms and impairment, the capacity to mentalize, the global functioning and the quality of interpersonal relations. There will be assessments of therapy success before, during, after the end of treatment and twelve months after therapy. The aim of the study is to provide evidence of efficacy of mentalization based group therapy in a heterogeneous patient sample and with this to optimize the health care in day clinics.

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Brief Summary in Scientific Language

The controlled health care study investigates the efficacy of mentalization based group therapy compared to psychodynamic group therapy in a day clinic. The target population is a heterogeneous patient sample. The aim of the study is to prove if the ability to mentalize improves more in the condition of the mentalization based treatment than in the psychodynamic treatment. Furthermore it is of interest if there is a higher reduction of mental symptoms in the mentalization based treatment than in the other group. According to a naturalistic design the patients of a psychotherapy day clinic are assigned to one of the two treatment groups (approx. 52 patients per group). The two groups exclusively differ from each other in the kind of group treatment. The setting - day clinic, four psychotherapy-groups per week, 90 minutes duration - is identically. The treatment has an average duration of nine weeks. There will be multiperspective, multimodal and multidimensional assessments before, during, after the end of treatment and twelve months after therapy. Outcome measurements of the severity of symptoms and impairment, of ability of mentalization, of global functioning and of quality of interpersonal relations will be used. For statistical analysis parametric and non parametric tests, power calculations, multiple regressions and a mediator-moderator-model will be applied.

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Organizational Data

  •   DRKS00003396
  •   2012/01/26
  •   [---]*
  •   yes
  •   Approved
  •   59/2010, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

  •   U1111-1123-4560 
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Health Condition or Problem studied

  •   Diagnosis of ICD-10 chapter V (F) with exception of F0, F2 and acute abuse of substance
  •   F10-F19 -  Mental and behavioural disorders due to psychoactive substance use
  •   F30-F39 -  Mood [affective] disorders
  •   F40-F48 -  Neurotic, stress-related and somatoform disorders
  •   F50-F59 -  Behavioural syndromes associated with physiological disturbances and physical factors
  •   F60-F69 -  Disorders of adult personality and behaviour
  •   F80-F89 -  Disorders of psychological development
  •   F90-F98 -  Behavioural and emotional disorders with onset usually occurring in childhood and adolescence
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Interventions/Observational Groups

  •   Mentalization based group therapy in a day clinic setting (Within a day clinic setting patients receive mentalization based group psychotherapy four times per week with a duration of 90 minutes)
  •   Psychodynamic group psychotherapy in a day clinic setting
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary efficacy endpoint is the reduction of global severity impairment evaluated by the patients (GSI/ SCL-90-R) twelve month after treatment.

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Secondary Outcome

Key secondary endpoints in the perspective of patients are different aspects of mentalization abilities (LEAS, MASC, AQ-k), interpersonal problems (IIP-D) and goals of therapy (GAS).
Secondary endpoints in the perspectives of the therapists and the experts are the global (GAF) and social (SOFAS) functioning, the global severity impairment (BSS), the aims of therapy (exclusively therapists) and mental disorders of axis one and two of DSM-IV (SCID I and I; exclusively experts).
The main points of assessments are before, after therapy and twelve month after therapy. At this points the SCL-90-R, LEAS, MASC, subtests 1 and 4 of the LPS, AQ-k, IIP-D, GAF, SOFAS and BSS are used. The aims of therapy are only assessed before and after therapy. SCID I and II are used before therapy and twelve months after therapy.
To assess the process the patients complete the SCL-90-R weekly and evaluate the group climate (GCQ) after each group. The therapists complete the GAF, SOFAS and BSS after four weeks of therapy.
The adherence of therapy is rated by trained experts. For this randomly chosen audiotapes of group sessions are rated with a self developed questionnaire.
Furthermore a semistructured in-depth interview with the patients is used to assess the curative factors.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2011/09/02
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Diagnosis of ICD-10 chapter V (F)

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Exclusion Criteria

diagnosis F0, F2 of ICD-10 chapter V (F) and significant difficulties in german language and cognitive impairment

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Addresses

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    • Klinik für Psychiatrie, Psychotherapie und Psychosomatik des EVK Bergisch Gladbach - Kooperationsklinik der Universität Witten/Herdecke - Fakultät für Gesundheit
    • Mr.  Prof. Dr. med.  Ulrich  Schultz-Venrath 
    • Ferrenbergstraße 24
    • 51465  Bergisch Gladbach
    • Germany
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    • Klinik für Psychiatrie,Psychotherapie und Psychosomatik des EVK Bergisch Gladbach - Kooperationsklinik der Universität Witten/Herdecke - Fakultät für Gesundheit
    • Mr.  Prof. Dr. med.  Ulrich  Schultz-Venrath 
    • Ferrenbergstraße 24
    • 51465  Bergisch Gladbach
    • Germany
    end of 1:1-Block address scientific-contact
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    • Klinik für Psychiatrie, Psychotherapie und Psychosomatik des EVK Bergisch Gladbach - Kooperationsklinik der Universität Witten/Herdecke
    • Mr.  Prof. Dr. med.  Ulrich  Schultz-Venrath 
    • Ferrenbergstr Str. 24
    • 51465  Bergisch Gladbach
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Psychiatrie, Psychotherapie und Psychosomatik des EVK Bergisch Gladbach Kooperationsklinik der Universität Witten/Herdecke
    • Mr.  Prof. Dr. med.   Ulrich  Schultz-Venrath 
    • Ferrenbergstr Str. 24
    • 51465  Bergisch Gladbach
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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* This entry means the parameter is not applicable or has not been set.