ClinicalTrials.gov
ClinicalTrials.gov Menu

Functional Neuroimaging Effects of Cognitive Remediation Training

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00481156
Recruitment Status : Completed
First Posted : June 1, 2007
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
Minnesota Medical Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
The purpose of this study is to examine behavioral and functional brain changes occuring as a result of cognitive remediation training in patients with schizophrenia. Extension and specificity of related changes will also be examined.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Cognitive Remediation Behavioral: Cognitive Behavioral Social Skills Training Other: Retest in Health Controls Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, placebo-controlled, single-blind. An untreated healthy control group was also included to examine simple retest effects.
Masking: Single (Participant)
Masking Description: Participants were randomized to computer-based cognitive training or active social-skills groups. Healthy controls (n=9) received no treatment.
Primary Purpose: Basic Science
Official Title: Functional Neuroimaging Effects of Cognitive Remediation Training
Actual Study Start Date : March 1, 2005
Actual Primary Completion Date : February 28, 2007
Actual Study Completion Date : February 28, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Patients: Cognitive Remediation
Patients in the cognitive REM condition attended up to 25 h of training in small groups over 4-6 weeks based on the approach to cognitive remediation described by Wexler and Bell (2005). Patients performed tasks designed to train attention and memory from the battery available within a computerized software package (CogPack Marker Software). This training protocol has been shown to improve memory and executive functioning in patients with schizophrenia (Sartory et al, 2005) and tasks chosen were designed to produce improved working memory and attention capacity in the treated group. In addition, patients in the REM group trained on the word N-back one to two times a week and on N-back tasks using a variety of other stimuli (such as faces) one to two times a week to support the generalization of working memory improvements.
Behavioral: Cognitive Remediation
Active Comparator: Patients: Cognitive-Behavioral Social Skills Training
Patients in the CBSST group also attended up to 25 h of treatment but followed a manualized group therapy protocol (Granholm et al, 2005) using cognitive and behavioral therapy methods to increase patients' skills in symptom recognition, communication, problem solving, and relapse prevention. In both conditions, the facilitators interacted with the clients throughout small group (B4 patients) sessions: in the REM group, this mostly involved brief one-on-one discussions regarding task performance; in the CBSST condition, this interaction was in the context of the group milieu.
Behavioral: Cognitive Behavioral Social Skills Training
Controls: Retest control group
Estimate of normal brain functioning and retest effects
Other: Retest in Health Controls
Pre/Post test performance and neuroimaging only



Primary Outcome Measures :
  1. Working Memory performance [ Time Frame: Post-test ]
    N-Back Performance

  2. Brain activation [ Time Frame: Post-test ]
    Changes in prefrontal cortical functioning



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • Stable outpatient

Exclusion Criteria:

  • Current drug abuse or dependence
  • History of neurological damage, disorder, or disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481156


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Minnesota Medical Foundation
Investigators
Principal Investigator: Angus W MacDonald, Ph.D. University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Kelvin O Lim, Ph.D. University of Minnesota - Clinical and Translational Science Institute

Publications of Results:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00481156     History of Changes
Other Study ID Numbers: 0404M58647
CogRehab
First Posted: June 1, 2007    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders