Effectiveness of Targeted Cognitive Training for Neurological Deficits in People With Schizophrenia (CRIS)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Targeted cognitive training (TCT)
Computer games
Sponsored by

About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizoaffective Disorder, Cognitive Remediation, fMRI
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
Sites / Locations
- San Francisco Department of Veterans Affairs Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Participants will use commercially available computer games
Participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation
Outcomes
Primary Outcome Measures
Cognitive performance as measured by a neuropsychological battery
Secondary Outcome Measures
Symptom profile as measured by clinical interviews
Quality of life as measured by clinical interviews
Full Information
NCT ID
NCT00312962
First Posted
April 7, 2006
Last Updated
March 7, 2014
Sponsor
University of California, San Francisco
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00312962
Brief Title
Effectiveness of Targeted Cognitive Training for Neurological Deficits in People With Schizophrenia
Acronym
CRIS
Official Title
Neuroscience-Guided Remediation of Cognitive Deficits in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizoaffective Disorder, Cognitive Remediation, fMRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Participants will use commercially available computer games
Arm Title
2
Arm Type
Experimental
Arm Description
Participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation
Intervention Type
Behavioral
Intervention Name(s)
Targeted cognitive training (TCT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Computer games
Intervention Description
The control treatment involves commercially available computer games that participants practice 1 hour per day, 5 days per week, for 20 weeks.
Primary Outcome Measure Information:
Title
Cognitive performance as measured by a neuropsychological battery
Time Frame
Measured at Weeks 8, 14, and 8 and Month 6 follow-up
Secondary Outcome Measure Information:
Title
Symptom profile as measured by clinical interviews
Time Frame
Measured at Weeks 8, 14, and 8 and Month 6 follow-up
Title
Quality of life as measured by clinical interviews
Time Frame
Measured at Weeks 8, 14, and 8 and Month 6 follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophia Vinogradov, MD
Organizational Affiliation
UCSF, SFVAMC, NCIRE
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco Department of Veterans Affairs Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32141724
Citation
Puig O, Fisher M, Loewy R, Miley K, Ramsay IS, Carter CS, Ragland JD, Niendam T, Vinogradov S. Early- Versus Adult-Onset Schizophrenia as a Predictor of Response to Neuroscience-Informed Cognitive Training. J Clin Psychiatry. 2020 Mar 3;81(2):18m12369. doi: 10.4088/JCP.18m12369.
Results Reference
derived
PubMed Identifier
22992330
Citation
Panizzutti R, Hamilton SP, Vinogradov S. Genetic correlate of cognitive training response in schizophrenia. Neuropharmacology. 2013 Jan;64(1):264-7. doi: 10.1016/j.neuropharm.2012.07.048. Epub 2012 Aug 7.
Results Reference
derived
Learn more about this trial
Effectiveness of Targeted Cognitive Training for Neurological Deficits in People With Schizophrenia
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