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

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Effectiveness of Targeted Cognitive Training for Neurological Deficits in People With Schizophrenia
Official Title  Neuroscience-Guided Remediation of Cognitive Deficits in Schizophrenia
Brief Summary

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

Detailed Description

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 Phase Phase I, Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Cognitive performance as measured by a neuropsychological battery [ Time Frame: Measured at Weeks 8, 14, and 8 and Month 6 follow-up ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Symptom profile as measured by clinical interviews [ Time Frame: Measured at Weeks 8, 14, and 8 and Month 6 follow-up ] [ Designated as safety issue: No ]
Quality of life as measured by clinical interviews [ Time Frame: Measured at Weeks 8, 14, and 8 and Month 6 follow-up ] [ Designated as safety issue: No ]
Condition  Schizophrenia
Intervention  Behavioral: Targeted cognitive training (TCT)
Behavioral: Computer games
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  80
Start Date  April 2004
Completion Date April 2009
Eligibility Criteria 

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
Gender Both
Ages 18 Years to 60 Years
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Christine S. Holland, BA     415-221-4810 ext 5488     christine.holland@med.va.gov    
Contact: Laura Rymland, MA     415-221-4810 ext 3077     laura.rymland@va.gov    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00312962
Organization ID R01 MH68725
Secondary IDs †† DATR A2-AISZ
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Sophia Vinogradov, MD     UCSF, SFVAMC, NCIRE    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date February 2008
First Received Date  April 7, 2006
Last Updated Date February 13, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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