Evaluation of a Cognitive Adaptive E-treatment in Schizophrenia-diagnosed Adults
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2012 |
| End Date: | June 2015 |
Evaluation of a Cognitive Adaptive E-treatment in Schizophrenia-diagnosed Adults, A Remediation-based Approach
This study is a multi-site, double-blind, randomized, controlled clinical trial to assess
the safety and effectiveness of plasticity-based, adaptive, computerized-based cognitive
remediation treatment versus a computer-based control.
The investigators proposed that a computerized cognitive remediation program based upon the
principles of brain plasticity may improve information processing and thus drive clinically
significant improvements in cognitive and functional performance in individuals with
schizophrenia.
the safety and effectiveness of plasticity-based, adaptive, computerized-based cognitive
remediation treatment versus a computer-based control.
The investigators proposed that a computerized cognitive remediation program based upon the
principles of brain plasticity may improve information processing and thus drive clinically
significant improvements in cognitive and functional performance in individuals with
schizophrenia.
The symptoms of schizophrenia fall into three main categories: positive symptoms, negative
symptoms, and cognitive symptoms. Each category represents distinct functional challenges
and impedes patient productivity and overall quality of life.
Cognitive symptoms are pervasive and result in deficits in executive functioning (the
ability to understand information and use it to make decisions), attention (the ability to
identify, select, and focus on relevant sensory events), and working memory (the ability to
hold information in memory and then guide actions from it). These symptoms impair patients'
abilities to successfully perform everyday activities, including independent living,
employment, and social relationships, and in addition can cause great emotional distress.
Cognitive impairment in schizophrenia has now received substantial academic study, with over
24,000 research papers published in the field since 1990. This enormous body of work has
shown that cognitive impairment is likely to be present in virtually all patients with
schizophrenia, regardless of their severity of illness or treatment status. People with
schizophrenia typically perform 1-2 standard deviations below the mean of age-matched
controls (indicating substantial impairment) across the domains of speed of information
processing, attention, working memory, verbal and visual learning, reasoning and social
cognition.
While cognitive impairment in schizophrenia was originally assumed to be secondary to
positive or negative symptoms of the disorder, or related to the use of anti-psychotic
medications, recent research has conclusively shown that neither of these past assumptions
is true. For example, the landmark Clinical Antipsychotic Trials of Intervention
Effectiveness (CATIE) trial involving 1,493 participants demonstrated that negative symptoms
are only mildly correlated with cognitive function, and that positive symptoms are
completely uncorrelated with cognitive function. Furthermore, research has shown that
cognitive impairment is evident in people with schizophrenia before they are medicated,
prior to diagnosis, and in first-degree relatives of people diagnosed with schizophrenia;
indicating that medication is not the cause of cognitive impairment. In aggregate, these
data have established the well-accepted current viewpoint that cognitive dysfunction is a
core primary symptom and deficit in schizophrenia.
symptoms, and cognitive symptoms. Each category represents distinct functional challenges
and impedes patient productivity and overall quality of life.
Cognitive symptoms are pervasive and result in deficits in executive functioning (the
ability to understand information and use it to make decisions), attention (the ability to
identify, select, and focus on relevant sensory events), and working memory (the ability to
hold information in memory and then guide actions from it). These symptoms impair patients'
abilities to successfully perform everyday activities, including independent living,
employment, and social relationships, and in addition can cause great emotional distress.
Cognitive impairment in schizophrenia has now received substantial academic study, with over
24,000 research papers published in the field since 1990. This enormous body of work has
shown that cognitive impairment is likely to be present in virtually all patients with
schizophrenia, regardless of their severity of illness or treatment status. People with
schizophrenia typically perform 1-2 standard deviations below the mean of age-matched
controls (indicating substantial impairment) across the domains of speed of information
processing, attention, working memory, verbal and visual learning, reasoning and social
cognition.
While cognitive impairment in schizophrenia was originally assumed to be secondary to
positive or negative symptoms of the disorder, or related to the use of anti-psychotic
medications, recent research has conclusively shown that neither of these past assumptions
is true. For example, the landmark Clinical Antipsychotic Trials of Intervention
Effectiveness (CATIE) trial involving 1,493 participants demonstrated that negative symptoms
are only mildly correlated with cognitive function, and that positive symptoms are
completely uncorrelated with cognitive function. Furthermore, research has shown that
cognitive impairment is evident in people with schizophrenia before they are medicated,
prior to diagnosis, and in first-degree relatives of people diagnosed with schizophrenia;
indicating that medication is not the cause of cognitive impairment. In aggregate, these
data have established the well-accepted current viewpoint that cognitive dysfunction is a
core primary symptom and deficit in schizophrenia.
Inclusion Criteria:
- 18 years of older with confirmed diagnosis of Schizophrenia
- Adequate decisional and reading capacity
- Clinical stable
- Moderate or less severity on Positive and Negative Symptoms Scale
- English speaker
- Capable of completing clinical and cognitive assessment battery
- Lack of visual, auditory or motor capacity to participate in the study
- Minimal level of extrapyramidal symptoms
- Minimal level of depressive symptoms
Exclusion Criteria:
- Failure to meet suicidality rating criteria
- Prescribed greater than 2 anti-psychotics
- Significant alcohol and illicit drug use
- History of mental retardation or pervasive developmental disorder or other
neurological disorder
- Prior specified computer-based cognitive remediation training
- Participation in a concurrent study that could affect the outcome of this one
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