Skip to main content
OpenTrials
Completed

NCT Number: NCT03055520

Arithmetic Training With the Kumon Method for Cognition in Schizophrenia

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Training

Other

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

Other

nonspecific recreation including befriending and free simple activities.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Feb 16, 2017
Registry last updated
Feb 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.