Arithmetic Training With the Kumon Method for Cognition in Schizophrenia

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Other: placebo; Other: cognitive training

• Registration Number: NCT03055520
• Lead Sponsor: 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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2010-06
• Study Completion: 2011-06
• Status Verified: 2017-02
• Study First Submitted: 2017-02-10
• Study First Submitted QC: 2017-02-13
• Last Update Submitted: 2017-02-13
• Study First Posted: 2017-02-16
• Last Update Posted: 2017-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nonspecific recreation	placebo	-
arithmetic training (Kumon method)	cognitive training	-

Primary Outcome Measures

Name	Time	Method
improvement in attention	change from baseline to 6 months and to 12 months	neuropsychological battery
improvement in working memory	change from baseline to 6 months and to 12 months	neuropsychological battery
improvement in executive function	change from baseline to 6 months and to 12 months	neuropsychological battery

Secondary Outcome Measures

Name	Time	Method
psychopathology	change from baseline to 6 months and to 12 months	Evaluation with the Positive and Negative Syndrome Scale (PANSS)
functioning	change from baseline to 6 months and to 12 months	Evaluation with the Personal and Social Performance (PSP) scale