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NCT00223535 Clinical Trial

Cognitive Remediation and Social Skills Training in Schizophrenia

Schizophrenia Clinical Trial

Official title:
Cognitive Remediation and Social Skills Training in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00223535
Other study ID # 012-0013-164
Secondary ID
Status Completed
Phase N/A
First received September 14, 2005
Last updated September 14, 2005
Start date February 2003
Est. completion date March 2005

Study information
Verified date September 2005
Source The University of Texas Health Science Center at San Antonio
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine whether patients who participate in cognitive remediation prior to a skills training program learn and perform the skills better than patients who do not participate in cognitive remediation.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date March 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Cognitive Remediation

• Social Skills Training

Locations
Country Name City State
United States UTHSCSA San Antonio Texas

Sponsors (2)
Lead Sponsor Collaborator
The University of Texas Health Science Center at San Antonio National Alliance for Research on Schizophrenia and Depression

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Scores on tests of cognitive functioning
Secondary Outcomes on tests of social functioning after SST
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