Arithmetic Training With the Kumon Method for Cognition in Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055520
• Other study ID #: cognition schizophrenia
• Status: Completed
• Phase: N/A
• First received: February 10, 2017
• Last updated: February 13, 2017
• Start date: June 2009
• Est. completion date: June 2011

Study information

• Verified date: February 2017
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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
nonspecific recreation including befriending and free simple activities.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in attention	neuropsychological battery	change from baseline to 6 months and to 12 months
Primary	improvement in working memory	neuropsychological battery	change from baseline to 6 months and to 12 months
Primary	improvement in executive function	neuropsychological battery	change from baseline to 6 months and to 12 months
Secondary	psychopathology	Evaluation with the Positive and Negative Syndrome Scale (PANSS)	change from baseline to 6 months and to 12 months
Secondary	functioning	Evaluation with the Personal and Social Performance (PSP) scale	change from baseline to 6 months and to 12 months