Trial document




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  DRKS00005346

Trial Description

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Title

Integration by movement - a motor-cognitive therapy for patients with psychotic disorders

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The objective of the study is to evaluate the efficacy of a new specific, manualized combination of psychotherapy and kinesitherapy for group-therapy applied in the early treatment of patients with schizophrenic psychosis. Being integrated into the regular treatment the program consists of a combination of cognitive elements combined with kinesitherapy and physical training as well as psychoeducation of proven effectiveness for every single element. The aim of the study is to test, whether the new treatment will effect in a greater improvement of social functioning and greater reduction of negative symptoms of schizophrenia compared to common unspecific kinesitherapy as usual.

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Brief Summary in Scientific Language

The objective of this randomized, observer blinded, prospective bicentric study is to evaluate the efficacy of a new specific, manualized combination of psychotherapy and kinesitherapy for group-therapy applied in the early treatment of patients with schizophrenic psychosis. Being integrated into the regular treatment the program consists of a combination of cognitive elements combined with kinesitherapy and physical training as well as psychoeducation of proven effectiveness for every single element. The planned sample comprises 128 Patients with a schizophrenia spectrum psychosis (DSM-IV 295.xx, ICD-10 F20.x) aged between 18 and 55 years currently treated in one of two Psychiatric Departments (Klinik für Allgemeine Psychiatrie Heidelberg and Psychiatrisches Zentrum Nordbaden). The sample will be stratified for dose of antipsychotics at the time of allocation to the trial. After 18 treatment sessions (50 min.) we will test by group comparison to the common unspecific kinesitherapy as usual (n=64) , if the new treatment (n=64) will result in:
Primary Hypotheses:
-greater improvement of social functioning (GAF und SOFS Rating)
-greater reduction of negative symptoms of schizophrenia (PANSS)
Secondary Hypotheses:
-greater reduction of positive symptoms of schizophrenia (PANSS).
-greater improvement of executive functioning (Tower-Test, Labyrinth-Test, Corsi Block-Test).
- greater improvement in recognizing the intentions of others („Theory of Mind“, TOM-task, Schnell et al. 2011).
Exploratory Analysis:
- Is there a correlation between changes of executive functions, mentalising (tToM) capabilities, psychosocial functioning and quality of life?
- What is the correlation between the extent of positive- and negative symptoms and therapy-effects on social-cognitive and executive functions?
- What is the relation between positive and negative symptoms with attributional style (bias) und jumping to conclusions?
- has the new treatment a greater effect on attributional style (bias) and jumping to conclusions?
- Which domains of social functions will be changed by the treatment?

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Organizational Data

  •   DRKS00005346
  •   2013/10/04
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  •   yes
  •   Approved
  •   S-145/2013, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   U1111-1148-6198 
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Health Condition or Problem studied

  •   F20.- schizophrenia
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Interventions/Observational Groups

  •   motor-cognitive therapy , a manualized combination of cognitive elements combined with kinesitherapy and physical training as well as psychoeducation over 18 treatment sessions provided in 3 sessions per week (50 min.) with a minimun overall duration of 6 weeks
  •   standard kinesitherapy over 18 treatment sessions provided in 3 sessions per week (50 min.) with a minimun overall duration of 6 weeks
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

-negative symptoms of schizophrenia (PANSS)
-social functioning (GAF und SOFS Rating)

after 18 treatment sessions compared to baseline assessment prior to intervention

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Secondary Outcome

-positive symptoms of schizophrenia (PANSS).
-executive functioning (Tower-Test, Labyrinth-Test, Corsi Block-Test).
- ability to recognize the intentions of others („Theory of Mind“, TOM-task, Schnell et al. 2011).
after 18 treatment sessions compared to baseline assessment prior to intervention

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2013/10/07
  •   128
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

patients with a schizophrenia spectrum psychosis (DSM-IV 295.xx, ICD-10 F20.x) aged between 18 and 55 years, capable to give consent

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Exclusion Criteria

other disorders due to brain disease, damage and dysfunction, major depressive episode,
mental retardation, other chronic mental disorders, current substance abuse, serious medical conditions impairing physical exercise (e.g. angina pectoris, COPD)

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Addresses

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    • Klinik für Allgemeine PsychiatrieUniversitätsklinikum Heidelberg
    • Mr.  PD Dr. med.  Knut  Schnell 
    • Vossstr.2
    • 69115  Heidelberg
    • Germany
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    • Klinik für Allgemeinpsychiatrie, Psychotherapie und Psychosomatik IPsychiatrisches Zentrum Nordbaden
    • Mr.  Dr. med.  Markus  Schwarz 
    • Heidelberger Straße 1a
    • 69168  Wiesloch
    • Germany
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    • Universitätsklinikum Heidelberg, Allgemeine Psychiatrie
    • Ms.  Dipl.-Psych.  Kirsten  Guba 
    • Voßstraße 2
    • 69115  Heidelberg
    • Germany
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    • Universitätsklinikum HeidelbergAllgemeine Psychiatrie
    • Ms.  Dipl.-Psych.  Kirsten  Guba 
    • Voßstraße 2
    • 69115  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Dietmar Hopp Stiftung gGmbH
    • Raiffeisenstraße 51
    • 68789  St. Leon-Rot
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   2016/04/01
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Trial Publications, Results and other Documents

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