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Feasibility of Providing Cognitive Remediation to People With Schizophrenia in a Clinical Network

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00930150
First received: June 26, 2009
Last updated: April 15, 2011
Last verified: November 2010

June 26, 2009
April 15, 2011
July 2009
February 2010   (final data collection date for primary outcome measure)
Feasibility of a multisite trial using cognitive remediation [ Time Frame: Measured at post-treatment ] [ Designated as safety issue: No ]
Feasibility of a multi-site trial using cognitive remediation [ Time Frame: Measured at post-treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00930150 on ClinicalTrials.gov Archive Site
Effect of cognitive remediation on functional outcomes, including change from baseline on UCSD Performance Based Skills Assessment (UPSA) total score, Specific Levels of Functioning (SLOF) total score, and Cognitive Assessment Interview (CAI) total score [ Time Frame: Measured at post-treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Feasibility of Providing Cognitive Remediation to People With Schizophrenia in a Clinical Network
Cognitive Remediation in the Schizophrenia Trials Network

This study will test whether a cognitive remediation program to treat people with schizophrenia can be successfully implemented in a network of research clinics.

Neurocognitive impairments, or problems with thinking and brain function, are a core component of schizophrenia. Such impairments, which can range from moderate to severe, are strongly associated with decreased benefit from psychiatric rehabilitation and problems with treatment adherence, socialization, employment, quality of life, and relapse. Researchers believe that the failure of medication to improve cognition may occur because medication treatment lacks cognitive stimulation. Cognitive remediation programs are a way to provide that stimulation, and they have shown moderate efficacy in improving cognition in people with schizophrenia. Implementing these cognitive remediation programs as part of schizophrenia treatment has occurred only at individual sites with highly trained research personnel. This study will test whether cognitive remediation programs for schizophrenia can be feasibly implemented at a network of sites that do not specialize in cognitive remediation research. This pilot study will gather preliminary efficacy data, but a larger study is required to draw definitive conclusions about treatment effects.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Behavioral: Targeted cognitive training
    Adaptive computer exercises that systematically increase in task difficulty as each participant's performance ability improves
  • Behavioral: Computer control
    Commercially available computer games selected based on quality, ability to hold interest, and lack of disturbing content
  • Behavioral: Bridging groups
    Weekly group meetings that help participants apply their cognitive skills to everyday functioning, promote group identity, and promote socialization
  • Behavioral: Health and wellness groups
    Weekly group meetings that teach participants health and wellness skills
  • Experimental: Posit Science Intervention
    Participants will receive targeted cognitive training and participate in a bridging group.
    Interventions:
    • Behavioral: Targeted cognitive training
    • Behavioral: Bridging groups
  • Active Comparator: Control
    Participants will play commercially available computer games and participate in weekly groups to discuss health and wellness.
    Interventions:
    • Behavioral: Computer control
    • Behavioral: Health and wellness groups
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Demonstrates adequate decisional capacity to make a choice about participating in the research study
  • 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:

  • Psychiatric hospitalization within 8 weeks of random assignment
  • 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)
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00930150
N01 MH090001-07, N01-MH090001-07, PCC: DSIR AT
Yes
T. Scott Stroup, MD, MPH, University of North Carolina at Chapel Hill
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Richard Keefe, PhD Duke University
Principal Investigator: T. Scott Stroup, MD, MPH Columbia University
National Institute of Mental Health (NIMH)
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP