Feasibility of Providing Cognitive Remediation to People With Schizophrenia in a Clinical Network
NCT ID: NCT00930150
Last Updated: 2011-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
52 participants
INTERVENTIONAL
2009-07-31
2010-02-28
Brief Summary
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Detailed Description
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Participation in this study will last approximately 8 weeks. Participants will be randomly assigned to the Posit Science intervention group or the control group. Those in the Posit Science group will receive targeted cognitive training (TCT)-40 hours of adaptive computer exercises-and participate in a weekly bridging group that helps participants apply cognitive skills to everyday contexts. Length of the TCT may vary, depending on the availability of participants to complete the exercises. Those in the control group will play commercially available video games for the same number of hours and participate in a weekly health and wellness group. All participants will undergo assessments at baseline, mid-treatment, and post-treatment. Assessments will include self-report questionnaires and clinical interviews.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Posit Science Intervention
Participants will receive targeted cognitive training and participate in a bridging group.
Targeted cognitive training
Adaptive computer exercises that systematically increase in task difficulty as each participant's performance ability improves
Bridging groups
Weekly group meetings that help participants apply their cognitive skills to everyday functioning, promote group identity, and promote socialization
Control
Participants will play commercially available computer games and participate in weekly groups to discuss health and wellness.
Computer control
Commercially available computer games selected based on quality, ability to hold interest, and lack of disturbing content
Health and wellness groups
Weekly group meetings that teach participants health and wellness skills
Interventions
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Targeted cognitive training
Adaptive computer exercises that systematically increase in task difficulty as each participant's performance ability improves
Computer control
Commercially available computer games selected based on quality, ability to hold interest, and lack of disturbing content
Bridging groups
Weekly group meetings that help participants apply their cognitive skills to everyday functioning, promote group identity, and promote socialization
Health and wellness groups
Weekly group meetings that teach participants health and wellness skills
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of schizophrenia or schizoaffective disorder, as defined by DSM-IV-TR criteria and confirmed by the Structured Clinical Interview for DSM-IV (SCID)
* Positive and Negative Syndrome Scale (PANSS) hallucinatory behavior, unusual thought content, and conceptual disorganization ratings of no greater than moderately severe (i.e., item scores must be less than or equal to 5)
* Meets all of the following cognitive performance and English language criteria:
1. Learned English before age 12
2. Able to complete the baseline Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) validly, based on the judgment of the investigator
3. Raw score of 37 or greater on the Wide Range Achievement Test, reading subtest, 3rd edition (WRAT-3), used to establish minimum sixth grade reading level and estimated premorbid IQ
* Able to state specific goals relevant to the intervention that participant would like to achieve
* Able to participate in the computerized intervention, based on the judgment of the investigator
Exclusion Criteria
* Adjustment to antipsychotic treatment within 4 weeks of random assignment
* Currently taking an anticholinergic medication
* DSM-IV diagnosis of alcohol or substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months
* History of mental retardation, pervasive developmental disorder, or other neurological disorder (such as a traumatic brain injury, epilepsy, or Parkinson 's disease)
18 Years
55 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Responsible Party
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University of North Carolina at Chapel Hill
Principal Investigators
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Richard Keefe, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
T. Scott Stroup, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Yale University/Connecticut Mental Health Center
New Haven, Connecticut, United States
Emory University
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
University of Iowa Hospital
Iowa City, Iowa, United States
University of Massachusetts
Worcester, Massachusetts, United States
University of Minnesota School of Medicine
Minneapolis, Minnesota, United States
The University of North Carolina
Chapel Hill, North Carolina, United States
Philadelphia VA Medical Center-116A
Philadelphia, Pennsylvania, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
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References
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Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2.
Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.
Keefe RS, Vinogradov S, Medalia A, Buckley PF, Caroff SN, D'Souza DC, Harvey PD, Graham KA, Hamer RM, Marder SM, Miller DD, Olson SJ, Patel JK, Velligan D, Walker TM, Haim AJ, Stroup TS. Feasibility and pilot efficacy results from the multisite Cognitive Remediation in the Schizophrenia Trials Network (CRSTN) randomized controlled trial. J Clin Psychiatry. 2012 Jul;73(7):1016-22. doi: 10.4088/JCP.11m07100. Epub 2012 May 15.
Other Identifiers
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N01-MH090001-07
Identifier Type: -
Identifier Source: secondary_id
PCC: DSIR AT
Identifier Type: -
Identifier Source: secondary_id
N01 MH090001-07
Identifier Type: -
Identifier Source: org_study_id
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