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
  Purpose

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


Condition Intervention Phase
Schizophrenia
Behavioral: Targeted cognitive training
Behavioral: Computer control
Behavioral: Bridging groups
Behavioral: Health and wellness groups
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Remediation in the Schizophrenia Trials Network

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Feasibility of a multisite trial using cognitive remediation [ Time Frame: Measured at post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 52
Study Start Date: July 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Posit Science Intervention
Participants will receive targeted cognitive training and participate in a bridging group.
Behavioral: Targeted cognitive training
Adaptive computer exercises that systematically increase in task difficulty as each participant's performance ability improves
Behavioral: Bridging groups
Weekly group meetings that help participants apply their cognitive skills to everyday functioning, promote group identity, and promote socialization
Active Comparator: Control
Participants will play commercially available computer games and participate in weekly groups to discuss health and wellness.
Behavioral: Computer control
Commercially available computer games selected based on quality, ability to hold interest, and lack of disturbing content
Behavioral: Health and wellness groups
Weekly group meetings that teach participants health and wellness skills

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930150

Locations
United States, Connecticut
Yale University/Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Iowa
University of Iowa Hospital
Iowa City, Iowa, United States, 52242
United States, Massachusetts
University of Massachusetts
Worcester, Massachusetts, United States, 01605
United States, Minnesota
University of Minnesota School of Medicine
Minneapolis, Minnesota, United States, 55454
United States, North Carolina
The University of North Carolina
Chapel Hill, North Carolina, United States, 27599-7160
United States, Pennsylvania
Philadelphia VA Medical Center-116A
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Investigators
Principal Investigator: Richard Keefe, PhD Duke University
Principal Investigator: T. Scott Stroup, MD, MPH Columbia University
  More Information

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: T. Scott Stroup, MD, MPH, University of North Carolina at Chapel Hill
ClinicalTrials.gov Identifier: NCT00930150     History of Changes
Other Study ID Numbers: N01 MH090001-07, N01-MH090001-07, PCC: DSIR AT
Study First Received: June 26, 2009
Last Updated: April 15, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Schizoaffective Disorder

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 22, 2014