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

April 15, 2011 updated by: National Institute of Mental Health (NIMH)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University/Connecticut Mental Health Center
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory University
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • University of Massachusetts
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • University of Minnesota School of Medicine
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7160
        • The University of North Carolina
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Philadelphia VA Medical Center-116A
    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility of a multisite trial using cognitive remediation
Time Frame: Measured at post-treatment
Measured at post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Measured at post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Richard Keefe, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

June 26, 2009

First Submitted That Met QC Criteria

June 26, 2009

First Posted (Estimate)

June 30, 2009

Study Record Updates

Last Update Posted (Estimate)

April 19, 2011

Last Update Submitted That Met QC Criteria

April 15, 2011

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01 MH090001-07
  • N01-MH090001-07
  • PCC: DSIR AT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on Targeted cognitive training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe