Effectiveness of Targeted Cognitive Training for Neurological Deficits in People With Schizophrenia

Study Overview
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Brief Summary
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This study will determine the effectiveness of reward-intensive, computer-based targeted cognitive training in improving neurocognitive deficits in people with schizophrenia.

Detailed Description
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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.

Official Title
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Neuroscience-Guided Remediation of Cognitive Deficits in Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: Targeted cognitive training (TCT)
* Behavioral: Computer games


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of schizophrenia or schizoaffective disorder Good general health First language is English Clinically stable (i.e., no inpatient hospital stays for 3 months prior to study entry; on stable doses of medication) Exclusion Criteria: History of substance abuse within 6 months prior to study entry Neurological disorder Any metal in the body, or claustrophobia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Participants will use commercially available computer games | Behavioral: Computer games<br>* The control treatment involves commercially available computer games that participants practice 1 hour per day, 5 days per week, for 20 weeks.<br>|
| Experimental: 2<br>Participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation | Behavioral: Targeted cognitive training (TCT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive performance as measured by a neuropsychological battery |  | Measured at Weeks 8, 14, and 8 and Month 6 follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom profile as measured by clinical interviews |  | Measured at Weeks 8, 14, and 8 and Month 6 follow-up | 
| Quality of life as measured by clinical interviews |  | Measured at Weeks 8, 14, and 8 and Month 6 follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizoaffective Disorder, Cognitive Remediation, fMRI