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Enhancing the Outcome of Skills Training for People With Schizophrenia

This study has suspended participant recruitment.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00069433
First received: September 24, 2003
Last updated: November 17, 2005
Last verified: November 2005
History of Changes
  Purpose

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


Condition Intervention
Schizophrenia
 Procedure: Social skills and symptom management training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Skills Training for Schizophrenia: Enhancing Outcomes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment: 60
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • IQ < 70
  • Use of more than one antipsychotic medication
  • Use of benzodiazepines, tricyclic antidepressants, or anticholinergic medication commonly used to treat extrapyramidal symptoms
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00069433

Locations
United States, Connecticut
Hall-Brooke-The Center
Bridgeport, Connecticut, United States, 06606
Hall-Brooke Behavioral Health Services
Westport, Connecticut, United States, 06880
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00069433     History of Changes
Other Study ID Numbers: R01 MH66362, DSIR AT-SP
Study First Received: September 24, 2003
Last Updated: November 17, 2005
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Psychotic Disorders

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013