Predictors of Response to Cognitive Remediation in Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cognitive remediation
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring cognition, neuropsychology, Rehabilitation, treatment efficacy, cognitive remediation
Eligibility Criteria
Inclusion Criteria: Diagnosis of schizophrenia spectrum disorder English speakers Clinically stable No substance abuse in past 30 days Exclusion Criteria: Traumatic brain injury Neurological disease Diagnosis of mental retardation
Sites / Locations
- VA Connecticut Health Care System (West Haven)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
cognitive remediation
treatment as usual
Arm Description
cognitive remediation
treatment as usual
Outcomes
Primary Outcome Measures
Cognitive Performance
Change in verbal memory scores from baseline to end of active phase (2 months), measured as trials 1-5 total score on the California Verbal Learning Test -II (range 0-80, higher scores represent better performance).
Secondary Outcome Measures
Full Information
NCT ID
NCT00333970
First Posted
June 2, 2006
Last Updated
October 6, 2014
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00333970
Brief Title
Predictors of Response to Cognitive Remediation in Schizophrenia
Official Title
Predictors of Response to Cognitive Remediation in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine which variables predict improvement on a cognitive training task battery, used for patients with schizophrenia, and to determine the proportion of patients whose performance returns to normal following cognitive training
Detailed Description
It has been suggested that level of cognitive function is a "rate-limiter" for the efficacy of other psychosocial treatments in schizophrenia. Cognitive remediation, which entails training and practice of successively more difficult cognitive exercises, has shown efficacy in improving cognitive function. However, the rate of improvement has not been uniform among patients receiving this intervention. Given the time- and cost-intensiveness of cognitive remediation, it is important to examine variables that will predict response to this treatment, as well as to examine the clinical significance of any improvement.
The current proposal has two aims: 1) to determine which neuropsychological, demographic, and illness variables predict response to cognitive remediation training; and 2) to determine the proportion of patients whose performance returns to normal following cognitive remediation training. For the first part of the proposed study, 50 outpatients diagnosed with schizophrenia spectrum disorders will be invited to participate in an 8-week trial of cognitive remediation training. Detailed neuropsychological, demographic, symptom and illness course variables will be collected prior to training, at the conclusion of training, and 4 months from study intake. In order to answer the second question, additional data on the computerized task performance for healthy controls will be collected, and compared to patient data, in order to determine what constitutes normal-range performance
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
cognition, neuropsychology, Rehabilitation, treatment efficacy, cognitive remediation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cognitive remediation
Arm Type
Experimental
Arm Description
cognitive remediation
Arm Title
treatment as usual
Arm Type
No Intervention
Arm Description
treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
cognitive remediation
Intervention Description
individual cognitive training
Primary Outcome Measure Information:
Title
Cognitive Performance
Description
Change in verbal memory scores from baseline to end of active phase (2 months), measured as trials 1-5 total score on the California Verbal Learning Test -II (range 0-80, higher scores represent better performance).
Time Frame
baseline and 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of schizophrenia spectrum disorder
English speakers
Clinically stable
No substance abuse in past 30 days
Exclusion Criteria:
Traumatic brain injury
Neurological disease
Diagnosis of mental retardation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna Fiszdon, PhD
Organizational Affiliation
VA Connecticut Health Care System (West Haven)
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Health Care System (West Haven)
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Predictors of Response to Cognitive Remediation in Schizophrenia
We'll reach out to this number within 24 hrs