Functional Neuroimaging Effects of Cognitive Remediation Training

NCT ID: NCT00481156

Last Updated: 2018-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-01

Study Completion Date

2007-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, placebo-controlled, single-blind. An untreated healthy control group was also included to examine simple retest effects.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Participants were randomized to computer-based cognitive training or active social-skills groups. Healthy controls (n=9) received no treatment.

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive Remediation

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Social Skills Training

Intervention Type BEHAVIORAL

Controls: Retest control group

Estimate of normal brain functioning and retest effects

Group Type OTHER

Retest in Health Controls

Intervention Type OTHER

Pre/Post test performance and neuroimaging only

Interventions

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Cognitive Remediation

Intervention Type BEHAVIORAL

Cognitive Behavioral Social Skills Training

Intervention Type BEHAVIORAL

Retest in Health Controls

Pre/Post test performance and neuroimaging only

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of schizophrenia or schizoaffective disorder
* Stable outpatient

Exclusion Criteria

* Current drug abuse or dependence
* History of neurological damage, disorder, or disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Minnesota Medical Foundation

OTHER

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angus W MacDonald, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Kelvin O Lim, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 20428109 (View on PubMed)

Other Identifiers

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CogRehab

Identifier Type: -

Identifier Source: secondary_id

0404M58647

Identifier Type: -

Identifier Source: org_study_id

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