Enhancing the Outcome of Skills Training for People With Schizophrenia

September 23, 2013 updated by: New York State Psychiatric Institute

Skills Training for Schizophrenia: Enhancing Outcomes

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Hall-Brooke-The Center
      • Westport, Connecticut, United States, 06880
        • Hall-Brooke Behavioral Health Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute of Mental Health (NIMH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

September 24, 2003

First Submitted That Met QC Criteria

October 8, 2003

First Posted (Estimate)

October 9, 2003

Study Record Updates

Last Update Posted (Estimate)

September 24, 2013

Last Update Submitted That Met QC Criteria

September 23, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #4339
  • DSIR AT-SP
  • R01MH066362 (U.S. NIH Grant/Contract)

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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