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

Phase 1

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00312962
• Lead Sponsor: University of California, San Francisco

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 Timeline

• Study Start: 2004-04
• Study First Submitted: 2006-04-07
• Study First Submitted QC: 2006-04-07
• Study First Posted: 2006-04-11
• Primary Completion: 2012-03
• Study Completion: 2013-03
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-07
• Last Update Posted: 2014-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cognitive performance as measured by a neuropsychological battery	Measured at Weeks 8, 14, and 8 and Month 6 follow-up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

San Francisco Department of Veterans Affairs Medical Center; 🇺🇸 San Francisco, California, United States