Functional Neuroimaging Effects of Cognitive Remediation Training
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Working Memory performance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Masking Description
Participants were randomized to computer-based cognitive training or active social-skills groups. Healthy controls (n=9) received no treatment.
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Diagnosis of schizophrenia or schizoaffective disorder
- •Stable outpatient
Exclusion Criteria
- •Current drug abuse or dependence
- •History of neurological damage, disorder, or disease
Arms & Interventions
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.
Intervention: Cognitive Remediation (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.
Intervention: Cognitive Behavioral Social Skills Training (Behavioral)
Controls: Retest control group
Estimate of normal brain functioning and retest effects
Intervention: Retest in Health Controls (Other)
Outcomes
Primary Outcomes
Working Memory performance
Time Frame: Post-test
N-Back Performance
Brain activation
Time Frame: Post-test
Changes in prefrontal cortical functioning
Secondary Outcomes
No secondary outcomes reported