Enhancing the Outcome of Skills Training for People With Schizophrenia

NCT ID: NCT00069433

Last Updated: 2013-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2005-11-30

Brief Summary

This study will determine the effectiveness of skills training in people with schizophrenia and the applicability of the acquired skills in the "real world."

Detailed Description

People with schizophrenia have a large number of social and symptom management training programs available to them. Studies suggest that these training programs are effective, but their generalizability and effectiveness in outpatient settings has not been thoroughly examined. This study will examine the treatment outcomes of a skills training approach in schizophrenic individuals taking antipsychotic medication.

Participants taking stable doses of risperidone, olanzapine, or quetiapine will be randomly assigned to receive either intensive symptom management and social skills training or group therapy for 12 months. A verbal memory test will be used to stratify the randomization procedure and to control for neurocognitive functioning.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Social skills and symptom management training

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of schizophrenia or schizoaffective disorder for > 5 years
• Use of stable dose risperidone, olanzapine, or quetiapine for at least 1 month with no planned medication changes
• Social Behavior Scale (SBS) score > 45
• Willing and able to provide informed consent

Exclusion Criteria

• Intelligence Quotient < 70
• Use of more than one antipsychotic medication
• Use of benzodiazepines, tricyclic antidepressants, or anticholinergic medication commonly used to treat extrapyramidal symptoms
• Diagnostic and Statistical Manual (DSM)-IV criteria for alcohol or other substance dependence
• History of any traumatic brain injury leading to loss of consciousness for > 30 minutes
• Diagnosis of a comorbid medical condition that could interfere with antipsychotic medication treatment or the ability to complete the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hall-Brooke-The Center

Bridgeport, Connecticut, United States

Hall-Brooke Behavioral Health Services

Westport, Connecticut, United States

Countries

United States

Other Identifiers

R01MH066362

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DSIR AT-SP

Identifier Type: -

Identifier Source: secondary_id

#4339

Identifier Type: -

Identifier Source: org_study_id