Effectiveness of Targeted Cognitive Training for Neurological Deficits in People With Schizophrenia (CRIS)
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|ClinicalTrials.gov Identifier: NCT00312962|
Recruitment Status : Completed
First Posted : April 11, 2006
Last Update Posted : March 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Behavioral: Targeted cognitive training (TCT) Behavioral: Computer games||Phase 1 Phase 2|
Schizophrenia is a chronic brain disorder that causes severe disability. It is characterized by psychotic symptoms, including hallucinations and delusions. Neurocognitive deficits, such as impaired neurocognitive processing efficiency, also affect people with schizophrenia. This deficiency in the speed and accuracy with which the brain perceives and responds to targets causes scrambled messages to be transmitted in the brain, thereby affecting executive control and memory. Medications are available that effectively treat the psychotic symptoms. The neurocognitive deficits, however, do not subside with medication treatment, and are responsible for the failure to improve the e their psychosocial functioning of people with schizophrenia, even after their psychotic symptoms have gone into remission. The targeted cognitive training (TCT) exercises in this study are specifically designed to improve speed and accuracy in the perception of and response to verbal and visuo-spatial targets. This study will determine the effectiveness of reward-intensive, computer-based TCT in improving neurocognitive deficits in people with schizophrenia.
Participants in this double-blind study will be paired according to IQ and baseline symptom severity. One member of each pair will be randomly assigned to training exercises that use TCT. The other will be assigned to a control intervention, which will involve commercially available computer games. All participants will complete exercises with their assigned intervention for 1 hour per day, 5 days per week, until 90 hours of training has been accumulated. Neuroimaging will be performed on a subgroup of participants to examine changes in brain activation patterns in response to the cognitive training. Upon study completion and at the 6-month follow up visit, participants will be assessed for improvement in the following areas: cognitive performance; symptom profile; quality of life; and social cue recognition.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Neuroscience-Guided Remediation of Cognitive Deficits in Schizophrenia|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2013|
Active Comparator: 1
Participants will use commercially available computer games
Behavioral: Computer games
The control treatment involves commercially available computer games that participants practice 1 hour per day, 5 days per week, for 20 weeks.
Participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation
Behavioral: Targeted cognitive training (TCT)
TCT includes cognitive remediation exercises that participants practice 1 hour per day, 5 days per week, for 20 weeks. TCT exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal and visuo-spatial targets.
- Cognitive performance as measured by a neuropsychological battery [ Time Frame: Measured at Weeks 8, 14, and 8 and Month 6 follow-up ]
- Symptom profile as measured by clinical interviews [ Time Frame: Measured at Weeks 8, 14, and 8 and Month 6 follow-up ]
- Quality of life as measured by clinical interviews [ Time Frame: Measured at Weeks 8, 14, and 8 and Month 6 follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312962
|United States, California|
|San Francisco Department of Veterans Affairs Medical Center|
|San Francisco, California, United States, 94121|
|Principal Investigator:||Sophia Vinogradov, MD||UCSF, SFVAMC, NCIRE|