Functional Neuroimaging Effects of Cognitive Remediation Training

Study Overview
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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.

Official Title
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Functional Neuroimaging Effects of Cognitive Remediation Training

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: Cognitive Remediation
* Behavioral: Cognitive Behavioral Social Skills Training
* Other: Retest in Health Controls


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, placebo-controlled, single-blind. An untreated healthy control group was also included to examine simple retest effects.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients: Cognitive Remediation<br>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<br> <br> |
| Active Comparator: Patients: Cognitive-Behavioral Social Skills Training<br>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<br> <br> |
| Other: Controls: Retest control group<br>Estimate of normal brain functioning and retest effects | Other: Retest in Health Controls<br>* Pre/Post test performance and neuroimaging only<br>|

What is the study measuring?
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Primary Outcome Measures

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