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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00312962
First received: April 7, 2006
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Schizophrenia
Behavioral: Targeted cognitive training (TCT)
Behavioral: Computer games
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neuroscience-Guided Remediation of Cognitive Deficits in Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Enrollment: 80
Study Start Date: April 2004
Study Completion Date: March 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Experimental: 2
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312962

Locations
United States, California
San Francisco Department of Veterans Affairs Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Sophia Vinogradov, MD UCSF, SFVAMC, NCIRE
  More Information

No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00312962     History of Changes
Other Study ID Numbers: R01 MH068725, R01MH068725, DATR A2-AISZ
Study First Received: April 7, 2006
Last Updated: March 7, 2014
Health Authority: United States: Federal Government

Keywords provided by University of California, San Francisco:
Schizoaffective Disorder
Cognitive Remediation
fMRI

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014