Arithmetic Training With the Kumon Method for Cognition in Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cognitive training
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, cognition, arithmetic training, Kumon method
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
arithmetic training (Kumon method)
nonspecific recreation
Arm Description
Outcomes
Primary Outcome Measures
improvement in attention
neuropsychological battery
improvement in working memory
neuropsychological battery
improvement in executive function
neuropsychological battery
Secondary Outcome Measures
psychopathology
Evaluation with the Positive and Negative Syndrome Scale (PANSS)
functioning
Evaluation with the Personal and Social Performance (PSP) scale
Full Information
NCT ID
NCT03055520
First Posted
February 10, 2017
Last Updated
February 13, 2017
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03055520
Brief Title
Arithmetic Training With the Kumon Method for Cognition in Schizophrenia
Official Title
Arithmetic Calculation Training With the Kumon Errorless Learning Method for Cognitive Rehabilitation of Patients With Schizophrenia: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2009 (Actual)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, cognition, arithmetic training, Kumon method
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
arithmetic training (Kumon method)
Arm Type
Experimental
Arm Title
nonspecific recreation
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
cognitive training
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
nonspecific recreation including befriending and free simple activities.
Primary Outcome Measure Information:
Title
improvement in attention
Description
neuropsychological battery
Time Frame
change from baseline to 6 months and to 12 months
Title
improvement in working memory
Description
neuropsychological battery
Time Frame
change from baseline to 6 months and to 12 months
Title
improvement in executive function
Description
neuropsychological battery
Time Frame
change from baseline to 6 months and to 12 months
Secondary Outcome Measure Information:
Title
psychopathology
Description
Evaluation with the Positive and Negative Syndrome Scale (PANSS)
Time Frame
change from baseline to 6 months and to 12 months
Title
functioning
Description
Evaluation with the Personal and Social Performance (PSP) scale
Time Frame
change from baseline to 6 months and to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Arithmetic Training With the Kumon Method for Cognition in Schizophrenia
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