Trial document




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  DRKS00006751

Trial Description

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Title

Effects of computer aided cognitive remediation on cognitive and non-cognitive measures in depressive patients

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Similar to schizophrenic patients, depressive patients also suffer from deficits in attention, memory and problem solving. These deficits are negatively correlated with social and vocational functioning. The current study will investigate whether computer-based cognitive training in depressed patients
(1) leads to improvements in cognitive performance,
(2) increases social competence, self-efficacy and motivation for treatment, and
(3) contibutes to a more rapid decline in depressive symptoms.

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Brief Summary in Scientific Language

Cognitive deficits in schizophrenic and depressed patients affect further course of illness as well social and vocational functioning. Recent meta-analyzes consistently found medium effect sizes for the efficacy of cognitive training in schizophrenia patients. These results raise the question of whether patients with depressive disorders might profit from cognitive remediation in a similar way. Concerning this topic, only few controlled studies with very small sample sizes have been conducted yet. In these studies, a cognitive remediation strategy using few training sessions per week for a longer period of time was applied to outpatients. So far, therefore, is completely unclear whether cognitive training could also be successfully applied to inpatients who have to be trained more frequently during the shorter time span of their inpatient stay. The perceived progress in the training tasks processed by the patients could additionally influence the participants’ intrinsic motivation for therapeutic treatment as well as their self-efficacy and thus may also positively influence the course of their depressive symptoms.

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006751
  •   2014/09/25
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  •   yes
  •   Approved
  •   14-101-0109, Ethikkommission an der Universität Regensburg
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Secondary IDs

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Health Condition or Problem studied

  •   F33 -  Recurrent depressive disorder
  •   F32 -  Depressive episode
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Interventions/Observational Groups

  •   Three 50-minute cognitive training sessions per week using a computerized cognitive remediation software in small groups (max. 3 patients) over a period of 4 weeks, for a total of 12 sessions.
  •   Treatment as usual
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Cognitive performance: problem solving (measured by the Wisconsin Card Sorting Test and the Trail-Making Test B), visual-spatial and verbal working memory, visual-spatial and verbal memory (assessed by the Wechsler Memory Scale Revised), selective attention (measured with the Continuous performance test) and cognitive processing speed (measured by the Trail-Maiking test A) before and after treatment

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Secondary Outcome

Depressive symptoms, measured by the Hamilton Depression Rating Scale (HAMD) and the Beck Depression Scale (BDI) before and after treatment

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/10/15
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients suffering from unipolar depression (ICD-10: F32.x or F33.x);
Ability to participate in the default non-drug therapy program

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Exclusion Criteria

no particular exclusion criteria

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Addresses

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    • Sozialstiftung Bamberg Klinik für Psychiatrie, Psychosomatik und Psychotherapie
    • Mr.  Prof.  Göran  Hajak 
    • St.-Getreu-Str. 18
    • 96049  Bamberg
    • Germany
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    • Sozialstiftung Bamberg Klinik für Psychiatrie, Psychotherapie und Psychosomatik
    • Mr.  Dr.  Wolfgang  Trapp 
    • St. Getreu-Str. 18
    • 96049  Bamberg
    • Germany
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    • Sozialstiftung Bamberg Klinik für Psychiatrie, Psychosomatik und Psychotherapie
    • Mr.  Prof.  Göran  Hajak 
    • St.-Getreu-Str. 18
    • 96049  Bamberg
    • Germany
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Sources of Monetary or Material Support

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    • Sozialstiftung Bamberg Klinik für Psychiatrie, Psychosomatik und Psychotherapie
    • St.-Getreu-Straße 18
    • 96049  Bamberg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/01/31
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Trial Publications, Results and other Documents

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