- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00223535
Cognitive Remediation and Social Skills Training in Schizophrenia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects are 40 stable outpatients with schizophrenia or schizoaffective disorder who are receiving medication and routine follow-up care at community clinics in San Antonio, Texas.
Patients receive baseline assessments and then are randomly assigned to either Cognitive Remediation (CR) or Keyboarding Skills (KS) for a period of 8 weeks. Following 8 weeks of treatment in either CR or KS, all patients participated in Social Skills Training (SST) for a period of 8 weeks. Assessments conducted by raters blinded to treatment condition are repeated following either remediation or control treatment, and again following SST.
Treatment groups Cognitive Remediation (CR) -- The CR program is based upon teaching techniques developed within educational psychology that promote intrinsic motivation and task engagement. The program uses existing computer software packages (e.g., Oregon Trail) with engaging story lines or activities, and built-in reinforcement of correct responses to help patients with schizophrenia develop attention, memory, planning, and problem-solving skills. CR is delivered in a computer lab setting with a facilitator present to assist patients.
Keyboarding Skills (KS) -- Control Treatment: The control treatment is an engaging self-paced software program designed to teach typing skills. KS is delivered in a computer lab setting with a facilitator present.
Both the KS and CR are administered in small groups of three to five patients each.
Social Skills Training (SST) -- SST is a manual-driven, behavioral rehabilitation program teaching basic conversation and social problem-solving skills (Bellack et al., 1997). SST runs for 8 weeks and is conducted in small groups that meet twice weekly.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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San Antonio, Texas, United States, 78229
- UTHSCSA
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of schizophrenia/schizoaffective disorder
- currently receiving treatment with an atypical antipsychotic medication
- between the ages of 18 and 60 years
- speak English as their primary language
- has at least a 6th grade level of reading (WRAT) Exclusion Criteria
- no current diagnosis of substance abuse or dependence
- no documented history of head injury, epilepsy or mental retardation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Scores on tests of cognitive functioning
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Secondary Outcome Measures
Outcome Measure |
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Outcomes on tests of social functioning after SST
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Collaborators and Investigators
Investigators
- Principal Investigator: Dawn I Velligan, Ph.D., University of Texas
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 012-0013-164
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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