Perceptual Deficits in Schizophrenia
Primary Purpose
Schizophrenia, Schizoaffective Disorder
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sensory Information Processing Training
Active Control Training
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- schizophrenia or schizoaffective disorder
- English speaking and reading
Exclusion Criteria:
- current substance abuse
- visual impairment
- neurological conditions
- current enrollment in another research study
Sites / Locations
- Yale University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sensory Information Processing Training
Active Control Training
Arm Description
Computerized training designed to improve sensory processing
Commercially available computer exercises that were not designed specifically to improve sensory information processing.
Outcomes
Primary Outcome Measures
Cognitive test performance
Neuropsychological testing
Secondary Outcome Measures
Psychiatric symptoms
Clinical interviews and ratings
Social Functioning
Clinical rating scales
Full Information
NCT ID
NCT02337439
First Posted
January 8, 2015
Last Updated
November 3, 2017
Sponsor
VA Connecticut Healthcare System
Collaborators
Brain & Behavior Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02337439
Brief Title
Perceptual Deficits in Schizophrenia
Official Title
Cognitive Remediation for Perceptual Deficits in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Connecticut Healthcare System
Collaborators
Brain & Behavior Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study, participants with schizophrenia and schizoaffective are given computer exercises to complete. The goals of the study are to determine whether: 1) any of the computer exercises can improve information processing problems in schizophrenia, 2) improvements in information processing are related to other cognitive improvements, and 3) there are changes in brain activity associated with using the computer exercises.
The study will involve clinical interviews, cognitive tests, and frequent computerized cognitive training over the course of 2 months. Some participants will also have electroencephalography, a non-invasive test that measures brain activity, to determine whether there are changes in brain activity with the computer training.
Detailed Description
Schizophrenia is a disabling neurodevelopmental illness, affecting nearly 1% of the population. The disability of schizophrenia is due in large part to the effects of the illness on cognitive faculties. Current medications for schizophrenia do not generally improve cognition, so a major contribution to disability remains undertreated. Computerized cognitive remediation programs, which produce activity-dependent recruitment of neural resources to specifically enhance under-functioning brain systems, have been effective at improving both cognition and community functioning in patients with schizophrenia, but the effects are still modest. Our preliminary work has suggested that our training is associated with improvements in visual memory, though visual memory has been a cognitive area more refractory to cognitive training.
In this study, participants with schizophrenia or schizoaffective disorder will be randomized to receive different computer exercises to help determine whether computer exercises can improve memory in schizophrenia, and whether the cognitive training is associated with changes in neural activity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sensory Information Processing Training
Arm Type
Experimental
Arm Description
Computerized training designed to improve sensory processing
Arm Title
Active Control Training
Arm Type
Active Comparator
Arm Description
Commercially available computer exercises that were not designed specifically to improve sensory information processing.
Intervention Type
Behavioral
Intervention Name(s)
Sensory Information Processing Training
Intervention Description
Computer exercises requiring identification of visual stimuli on computer screen and response with keyboard
Intervention Type
Behavioral
Intervention Name(s)
Active Control Training
Intervention Description
Commercially available educational software
Primary Outcome Measure Information:
Title
Cognitive test performance
Description
Neuropsychological testing
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Psychiatric symptoms
Description
Clinical interviews and ratings
Time Frame
up to 6 months
Title
Social Functioning
Description
Clinical rating scales
Time Frame
up to 6 months
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:
schizophrenia or schizoaffective disorder
English speaking and reading
Exclusion Criteria:
current substance abuse
visual impairment
neurological conditions
current enrollment in another research study
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18514488
Citation
Tandon R, Keshavan MS, Nasrallah HA. Schizophrenia, "just the facts" what we know in 2008. 2. Epidemiology and etiology. Schizophr Res. 2008 Jul;102(1-3):1-18. doi: 10.1016/j.schres.2008.04.011. Epub 2008 Jun 2.
Results Reference
background
PubMed Identifier
8610818
Citation
Green MF. What are the functional consequences of neurocognitive deficits in schizophrenia? Am J Psychiatry. 1996 Mar;153(3):321-30. doi: 10.1176/ajp.153.3.321.
Results Reference
background
PubMed Identifier
18451009
Citation
Carpenter WT, Buchanan RW. Lessons to take home from CATIE. Psychiatr Serv. 2008 May;59(5):523-5. doi: 10.1176/ps.2008.59.5.523.
Results Reference
background
PubMed Identifier
18056233
Citation
McGurk SR, Twamley EW, Sitzer DI, McHugo GJ, Mueser KT. A meta-analysis of cognitive remediation in schizophrenia. Am J Psychiatry. 2007 Dec;164(12):1791-802. doi: 10.1176/appi.ajp.2007.07060906.
Results Reference
background
PubMed Identifier
21406461
Citation
Wykes T, Huddy V, Cellard C, McGurk SR, Czobor P. A meta-analysis of cognitive remediation for schizophrenia: methodology and effect sizes. Am J Psychiatry. 2011 May;168(5):472-85. doi: 10.1176/appi.ajp.2010.10060855. Epub 2011 Mar 15.
Results Reference
background
PubMed Identifier
23043873
Citation
Surti TS, Wexler BE. A pilot and feasibility study of computer-based training for visual processing deficits in schizophrenia. Schizophr Res. 2012 Dec;142(1-3):248-9. doi: 10.1016/j.schres.2012.09.013. Epub 2012 Oct 6. No abstract available.
Results Reference
background
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Perceptual Deficits in Schizophrenia
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