Arithmetic Training With the Kumon Method for Cognition in Schizophrenia

Study Overview
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Brief Summary
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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).

Official Title
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Arithmetic Calculation Training With the Kumon Errorless Learning Method for Cognitive Rehabilitation of Patients With Schizophrenia: a Randomized Controlled Trial

Conditions
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Schizophrenia

Intervention / Treatment
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* Other: cognitive training
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: arithmetic training (Kumon method)<br> | Other: cognitive training<br>* 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).<br>|
| Placebo Comparator: nonspecific recreation<br> | Other: placebo<br>* nonspecific recreation including befriending and free simple activities.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in attention | neuropsychological battery | change from baseline to 6 months and to 12 months | 
| improvement in working memory | neuropsychological battery | change from baseline to 6 months and to 12 months | 
| improvement in executive function | neuropsychological battery | change from baseline to 6 months and to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychopathology | Evaluation with the Positive and Negative Syndrome Scale (PANSS) | change from baseline to 6 months and to 12 months | 
| functioning | Evaluation with the Personal and Social Performance (PSP) scale | change from baseline to 6 months and to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arithmetic training, Kumon method, schizophrenia, cognition