Trial document




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  DRKS00003738

Trial Description

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Title

Prevention of aggressive behavior occuring in psychotic disorders by compex intervention in outpatient setting

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The study focusses on patients with psychotic disorders with compulsory admission because of aggressive behavior against others. After the compulsatory hospital stay patients get an outpatient treatment of six month consisting of a compex intervention. The interventions consist of several nonpharmacological treatments all adopted for the special needs of these patients with aggression. Treatment occures indvidualized in a group and in a personal setting. The aim is to avoid further compulsory admissions. The project adresses patients with psychotic disorders and hosptilization by law because of dangerous behavior against others. A special treatment option of psychotherapy and sociotherapie etc. is offered for them in a group and single setting and of six month duration. The treatment modules are focussed on the special needs of this group, and are applied individualized.
The rate of rehospitalization of the treatmetn group is compaired with rate of rehospitalization of a matched comparison group (artificial control group) out of routine data, who did not get any special treatment but treatmetn as ususal.

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Brief Summary in Scientific Language

The aim is to optimize the treatment of patients with diagnoses of schizophrenia or bipolar disorders and dangeres / aggressiv behavior after a compulsory treatment. Patients with illness related dangerous behavior or aggression as defined by German law have a higher risk to become forensik patients in future. The intervention focusses on the risk of a forensic development and combines treatment options from the forensic aftercare and guideline treatment of general psychiatry.

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Organizational Data

  •   DRKS00003738
  •   2012/05/03
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  •   yes
  •   Approved
  •   3781, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

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Health Condition or Problem studied

  •   F20.0 -  Paranoid schizophrenia
  •   F31.0 -  Bipolar affective disorder, current episode hypomanic
  •   F31.1 -  Bipolar affective disorder, current episode manic without psychotic symptoms
  •   F31.2 -  Bipolar affective disorder, current episode manic with psychotic symptoms
  •   F31.6 -  Bipolar affective disorder, current episode mixed
  •   F31.8 -  Other bipolar affective disorders
  •   F25 -  Schizoaffective disorders
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Interventions/Observational Groups

  •   individualized complex interventions outpatient setting, 6 month
  •   treatment as usual outpatient treatment 6 months
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Aim: avoidance of compulsory admissions; catamnesis 6 month, Outcome rate of further compulsory admissions during 6 month after treatment phase

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Secondary Outcome

improvemnts in psychopathology and social functioning, measured by standardized scales (PANSS, GAF) at the timepoints before intervention, after intervention and 6 months after end of intervention.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/05/24
  •   79
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

former compulsory admissions concerning the local law and illnes related aggressive or dangeres behavior against others; diagnosis of schizophrenia, schizoaffectiv or bipolar disorder, age between 18 and 65, written informed consent, actuall voluntary treatment

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Exclusion Criteria

difficulties in German language

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Addresses

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    • LVR-Klinikum Düsseldorf, Klinken der Heinrich-Heine-Universität Düsseldorf
    • Mr.  Prof. Dr. med.  Wolfgang  Gaebel 
    • Bergische Landstr. 2
    • 40629  Düsseldorf
    • Germany
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    • LVR-Klinikum Düsseldorf, Kliniken der Heinrich-Heine-Universität Düsseldorf
    • Ms.  PD Dr. med.  Birgit  Janssen 
    • Bergische Landstr. 2
    • 40629  Düsseldorf
    • Germany
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    • LVR-Klinikum Düsseldorf, Kliniken der Heinrich-Heine-Universität
    • Ms.  Dr. Dipl. Psych.  Nicole  Frommann 
    • Bergische Landstr. 2
    • 40629  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Ministerium für Gesundheit, Emanzipation Pflege und Alter des Landes Nordrhein-Westfalen
    • Horionplatz 1,
    • 40213  Düsseldorf
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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