Schizophrenia Clinical Trial
Official title:
Evaluating Two Types of Cognitive Training in Veterans With Schizophrenia
Verified date | April 2019 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cognitive dysfunction is a major contributor to the poor community outcome of individuals with schizophrenia. Developing more effective cognitive remediation interventions is imperative to improve the daily lives of affected subjects and reduce the disability of this illness. The goal of this clinical trial is to evaluate two types of cognitive training approaches to determine which one is more beneficial for individuals with schizophrenia. This study also uses electrophysiological techniques to gain a better understanding of the mechanisms involved in cognitive remediation. Findings from this study will provide information about how to design the most optimally efficient cognitive training intervention to improve the cognitive and social functioning of patients with severe mental illness.
Status | Completed |
Enrollment | 105 |
Est. completion date | June 30, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Veterans with a Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder - Between 25 and 65 years of age - Estimated premorbid inteIligence quotient (IQ) > 70 (based on reading ability) - Understand spoken English sufficiently to comprehend the consent form - Clinically stable (i.e., no inpatient hospitalization in the 3 months, no changes in psychiatric medications in the 6 weeks, and no changes in housing in the 2 months, prior to enrollment) Exclusion Criteria: - Documented history of mental retardation or severe learning disability - Clinically significant neurological disease as determined by medical history (e.g., epilepsy, stroke) - History of serious head injury with loss of consciousness greater than 1 hour and concomitant neuropsychological sequelae - Meeting DSM-IV criteria for drug or alcohol dependence during the 6 months, or abuse during the month preceding study enrollment |
Country | Name | City | State |
---|---|---|---|
United States | Local Board and Care Facilities | Los Angeles | California |
United States | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Adcock RA, Dale C, Fisher M, Aldebot S, Genevsky A, Simpson GV, Nagarajan S, Vinogradov S. When top-down meets bottom-up: auditory training enhances verbal memory in schizophrenia. Schizophr Bull. 2009 Nov;35(6):1132-41. doi: 10.1093/schbul/sbp068. Epub 2009 Sep 10. Review. — View Citation
Fisher M, Holland C, Merzenich MM, Vinogradov S. Using neuroplasticity-based auditory training to improve verbal memory in schizophrenia. Am J Psychiatry. 2009 Jul;166(7):805-11. doi: 10.1176/appi.ajp.2009.08050757. Epub 2009 May 15. — View Citation
Green MF, Kern RS, Braff DL, Mintz J. Neurocognitive deficits and functional outcome in schizophrenia: are we measuring the "right stuff"? Schizophr Bull. 2000;26(1):119-36. Review. — View Citation
Light GA, Braff DL. Mismatch negativity deficits are associated with poor functioning in schizophrenia patients. Arch Gen Psychiatry. 2005 Feb;62(2):127-36. — View Citation
Medalia A, Choi J. Cognitive remediation in schizophrenia. Neuropsychol Rev. 2009 Sep;19(3):353-64. doi: 10.1007/s11065-009-9097-y. Epub 2009 May 15. Review. — View Citation
Popov T, Jordanov T, Rockstroh B, Elbert T, Merzenich MM, Miller GA. Specific cognitive training normalizes auditory sensory gating in schizophrenia: a randomized trial. Biol Psychiatry. 2011 Mar 1;69(5):465-71. doi: 10.1016/j.biopsych.2010.09.028. Epub 2010 Nov 18. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neurocognition | The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) was used to assess basic cognition. It includes tests representing 6 separable cognitive domains. The MCCB composite score (average of 6 domain t-scores) served as the primary cognitive outcome measure. Minimum and maximum values are 20 and 68. Higher scores mean a better outcome. | Within one week of training completion | |
Secondary | Electroencephalography (EEG) | A Mismatch Negativity (MMN) Paradigm was used to assess basic auditory processing. MMN amplitude was measured as the mean voltage in the 145-200 ms latency range at pooled frontocentral electodes. Minimum and maximum values are -8 and +2 microvolts. More negative scores mean a better outcome. | After 6 weeks of training and within one week of training completion | |
Secondary | Functional Capacity | The University of California San Diego (UCSD) Performance-based Skills Assessment (UPSA) was used to assess functional capacity. The UPSA total score served as a secondary functional outcome measure. Minimum and maximum values are 40 and 100. Higher scores mean a better outcome. | Within one week of training completion |
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