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Arithmetic Training With the Kumon Method for Cognition in Schizophrenia

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ClinicalTrials.gov Identifier: NCT03055520
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Mario R. Louza, MD, PhD, University of Sao Paulo

Brief Summary:
A randomized placebo-controlled trial of arithmetic training (with the Kumon Method) as an errorless learning method for improvement of cognition in schizophrenia. Outpatients were included after signing an informed consent. The trial consisted of 48 sessions of arithmetic training (twice a week, for 6 months) or placebo (nonspecific recreation, 48 sessions). The patients were evaluated with a neuropsychological battery at baseline, after 6 months (end of intervention) and after 12 months after baseline. The Positive and Negative Syndrome Scale (PANSS) and the Personal and Social Performance scale (PSP) were applied at baseline, after 6 months (end of intervention) and 12 months after baseline. Primary outcome was the performance on three cognitive domains (attention, executive functions and working memory).

Condition or disease Intervention/treatment Phase
Schizophrenia Other: cognitive training Other: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Arithmetic Calculation Training With the Kumon Errorless Learning Method for Cognitive Rehabilitation of Patients With Schizophrenia: a Randomized Controlled Trial
Actual Study Start Date : June 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: arithmetic training (Kumon method) Other: cognitive training
The Kumon method (www.kumon.com) of arithmetic calculation employs the errorless-learning (EL) strategy and consists of a structured, hierarchical series of exercises, beginning with simple ones (e.g. addition and subtraction) and then proceeding to more complex exercises (e.g. advanced algebra, calculus).

Placebo Comparator: nonspecific recreation Other: placebo
nonspecific recreation including befriending and free simple activities.




Primary Outcome Measures :
  1. improvement in attention [ Time Frame: change from baseline to 6 months and to 12 months ]
    neuropsychological battery

  2. improvement in working memory [ Time Frame: change from baseline to 6 months and to 12 months ]
    neuropsychological battery

  3. improvement in executive function [ Time Frame: change from baseline to 6 months and to 12 months ]
    neuropsychological battery


Secondary Outcome Measures :
  1. psychopathology [ Time Frame: change from baseline to 6 months and to 12 months ]
    Evaluation with the Positive and Negative Syndrome Scale (PANSS)

  2. functioning [ Time Frame: change from baseline to 6 months and to 12 months ]
    Evaluation with the Personal and Social Performance (PSP) scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Literate (≥5 years of formal education).
  • Diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR).
  • Clinically stable, with constant antipsychotic medication regimen for ≥8 weeks before screening
  • No hospitalizations in the last 6 months.

Exclusion Criteria:

  • Other Axis I psychiatric disorders, substance abuse or dependence.
  • History of head trauma or other neurologic diseases.
  • Severe or uncontrolled medical diseases, history of mental retardation or attendance in special-education classes,
  • Suicide risk
  • Participation in any other kind of psychosocial intervention.

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Responsible Party: Mario R. Louza, MD, PhD, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03055520     History of Changes
Other Study ID Numbers: cognition schizophrenia
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mario R. Louza, MD, PhD, University of Sao Paulo:
schizophrenia
cognition
arithmetic training
Kumon method
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders