Arithmetic Training With the Kumon Method for Cognition in Schizophrenia

February 13, 2017 updated by: Mario R. Louza, MD, PhD, University of Sao Paulo

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

February 10, 2017

First Submitted That Met QC Criteria

February 13, 2017

First Posted (Actual)

February 16, 2017

Study Record Updates

Last Update Posted (Actual)

February 16, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cognition schizophrenia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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