Arithmetic Training With the Kumon Method for Cognition in Schizophrenia

NCT03055520 | Completed

• 1 other identifier: cognition schizophrenia
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Schizophrenia

Keywords

schizophrenia; cognition; arithmetic training; Kumon method

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• psychopathology

  change from baseline to 6 months and to 12 months

• functioning

  change from baseline to 6 months and to 12 months

Study Arms (2)

arithmetic training (Kumon method)

EXPERIMENTAL

Other: cognitive training

nonspecific recreation

PLACEBO COMPARATOR

Other: placebo

Interventions

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).

arithmetic training (Kumon method)

placebo OTHER

nonspecific recreation including befriending and free simple activities.

nonspecific recreation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

MeSH Terms

Conditions

Schizophrenia

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 16, 2017
• Study Start: June 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2011
• Last Updated: February 16, 2017

Record last verified: 2017-02