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Functional Neuroimaging Effects of Cognitive Remediation Training

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cognitive Remediation
Cognitive Behavioral Social Skills Training
Retest in Health Controls
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • Stable outpatient

Exclusion Criteria:

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

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Patients: Cognitive Remediation

Patients: Cognitive-Behavioral Social Skills Training

Controls: Retest control group

Arm Description

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.

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.

Estimate of normal brain functioning and retest effects

Outcomes

Primary Outcome Measures

Working Memory performance
N-Back Performance
Brain activation
Changes in prefrontal cortical functioning

Secondary Outcome Measures

Full Information

First Posted
May 30, 2007
Last Updated
May 1, 2018
Sponsor
University of Minnesota
Collaborators
Minnesota Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00481156
Brief Title
Functional Neuroimaging Effects of Cognitive Remediation Training
Official Title
Functional Neuroimaging Effects of Cognitive Remediation Training
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2005 (Actual)
Primary Completion Date
February 28, 2007 (Actual)
Study Completion Date
February 28, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Minnesota Medical Foundation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, placebo-controlled, single-blind. An untreated healthy control group was also included to examine simple retest effects.
Masking
Participant
Masking Description
Participants were randomized to computer-based cognitive training or active social-skills groups. Healthy controls (n=9) received no treatment.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients: Cognitive Remediation
Arm Type
Experimental
Arm Description
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.
Arm Title
Patients: Cognitive-Behavioral Social Skills Training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Controls: Retest control group
Arm Type
Other
Arm Description
Estimate of normal brain functioning and retest effects
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Social Skills Training
Intervention Type
Other
Intervention Name(s)
Retest in Health Controls
Intervention Description
Pre/Post test performance and neuroimaging only
Primary Outcome Measure Information:
Title
Working Memory performance
Description
N-Back Performance
Time Frame
Post-test
Title
Brain activation
Description
Changes in prefrontal cortical functioning
Time Frame
Post-test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angus W MacDonald, Ph.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kelvin O Lim, Ph.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20428109
Citation
Haut KM, Lim KO, MacDonald A 3rd. Prefrontal cortical changes following cognitive training in patients with chronic schizophrenia: effects of practice, generalization, and specificity. Neuropsychopharmacology. 2010 Aug;35(9):1850-9. doi: 10.1038/npp.2010.52. Epub 2010 Apr 28.
Results Reference
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Functional Neuroimaging Effects of Cognitive Remediation Training

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