Functional Neuroimaging Effects of Cognitive Remediation Training

May 1, 2018 updated by: University of Minnesota
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

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
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • Stable outpatient

Exclusion Criteria:

  • Current drug abuse or dependence
  • History of neurological damage, disorder, or 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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
Other: Controls: Retest control group
Estimate of normal brain functioning and retest effects
Other: Retest in Health Controls
Pre/Post test performance and neuroimaging only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Working Memory performance
Time Frame: Post-test
N-Back Performance
Post-test
Brain activation
Time Frame: Post-test
Changes in prefrontal cortical functioning
Post-test

Collaborators and Investigators

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

Sponsor

University of Minnesota

Collaborators

Minnesota Medical Foundation

Investigators

  • Principal Investigator: Angus W MacDonald, Ph.D., University of Minnesota
  • Principal Investigator: Kelvin O Lim, Ph.D., University of Minnesota

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 (Actual)

March 1, 2005

Primary Completion (Actual)

February 28, 2007

Study Completion (Actual)

February 28, 2007

Study Registration Dates

First Submitted

May 30, 2007

First Submitted That Met QC Criteria

May 30, 2007

First Posted (Estimate)

June 1, 2007

Study Record Updates

Last Update Posted (Actual)

May 4, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0404M58647
  • CogRehab

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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