Functional Neuroimaging Effects of Cognitive Remediation Training

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Behavioral: Cognitive Behavioral Social Skills Training; Behavioral: Cognitive Remediation; Other: Retest in Health Controls

• Registration Number: NCT00481156
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03-01
• Primary Completion: 2007-02-28
• Study Completion: 2007-02-28
• Study First Submitted: 2007-05-30
• Study First Submitted QC: 2007-05-30
• Study First Posted: 2007-06-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients: Cognitive-Behavioral Social Skills Training	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.
Patients: Cognitive Remediation	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.
Controls: Retest control group	Retest in Health Controls	Estimate of normal brain functioning and retest effects

Primary Outcome Measures

Name	Time	Method
Brain activation	Post-test	Changes in prefrontal cortical functioning
Working Memory performance	Post-test	N-Back Performance

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States