Trial document





This trial has been registered retrospectively.
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  DRKS00019825

Trial Description

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Title

A retrospective study of cognitive impairments in general psychiatric patients using a screening instrument

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Trial Acronym

ReCog-SCIP

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URL of the Trial

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Brief Summary in Lay Language

Attention, memory or information processing disorders can occur in mental disorders such as schizophrenia or affective disorders. Extensive testing batteries are often carried out to investigate these cognitive disorders. This is easier with the SCIP (Screen for Cognitive Impairment in Psychiatry). The SCIP consists of a short test that is simple and easy to use. We have been using the SCIP regularly in our clinic since 2012. Now we want to investigate the mental status of the treated patients and whether it can improve during the course of treatment.

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Brief Summary in Scientific Language

Neuropsychological performance deficits are well described in the literature for those suffering from schizophrenia (F2) and affective disorders (F3). Full neuropsychological testing is not very practical in everyday clinical practice. At the same time, an assessment of neuropsychological deficits is of great importance due to the prognostic relevance for therapy and rehabilitation planning as well as occupational and employment perspectives for clinical everyday life. Screening instruments simplify diagnostics. SCIP is a screening instrument for cognitive impairments whose psychometric properties have been well investigated. This was integrated into the clinical routine diagnostics of our general psychiatric wards of the ZfP Südwürttemberg Clinic for Psychiatry and Psychotherapy I at the University of Ulm. In literature, diagnosis-specific differences in neuropsychological examinations are described. There are contradictory results on the stability of neuropsychological problems. Long-term observations of the course of the disease have so far not been described very much, if patients were examined using complex test batteries. Since 2012, the SCIP has been used in clinical diagnostics for the clinical assessment of individual cognitive performance so neuropsychological test results have been available for several years. These are now to be evaluated retrospectively for investigation.

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

Yes

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Description IPD sharing plan:

The study results should be published in a scientific paper. Preparation and submission of the paper is planned for 2020. A further (ethics) application does not have to be submitted.

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Organizational Data

  •   DRKS00019825
  •   2019/12/03
  •   [---]*
  •   yes
  •   Approved
  •   228/19, Ethik-Kommission der Universität Ulm
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Secondary IDs

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Health Condition or Problem studied

  •   F20-F29 -  Schizophrenia, schizotypal and delusional disorders
  •   F30-F39 -  Mood [affective] disorders
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Interventions/Observational Groups

  •   Retrospective observational study of performance in a cognitive screening of patients with F2 diagnosis in longitudinal and cross-section design
  •   Retrospective observational study of performance in a cognitive screening of patients with F3 diagnosis in longitudinal and cross-section design
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Performance of participants in screening (SCIP) from 2012 to 08/2019

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/09/26
  •   692
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Diagnosis of an F2 or F3 disorder; treated on ward 2053 or 2054 between 01.01.2012 to 21.08.2019

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Exclusion Criteria

incapable, willing to participate in diagnostics; all other diagnoses

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Addresses

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    • ZfP Südwürttemberg - Versorgungsforschung Klinik I für Psychiatrie und Psychotherapie Universität Ulm
    • Mr.  Prof. Dr.  Tilman  Steinert 
    • 88214  Ravensburg
    • Germany
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    • ZfP Südwürttemberg - medizinische Psychologie Klinik I für Psychiatrie und Psychotherapie
    • Ms.  Prof. Dr.  Carmen  Uhlmann 
    • Weingartshoferstr. 2
    • 88214  Ravensburg
    • Germany
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    • ZfP Südwürttemberg - medizinische Psychologie Klinik I für Psychiatrie und Psychotherapie
    • Ms.  Prof. Dr.  Carmen  Uhlmann 
    • Weingartshoferstr. 2
    • 88214  Ravensburg
    • Germany
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Sources of Monetary or Material Support

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    • ZfP Südwürttemberg - VersorgungsforschungKlinik I für Psychiatrie und Psychotherapie Universität Ulm
    • Mr.  Prof. Dr.  Tilman  Steinert 
    • 88214  Ravensburg
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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