search
Back to results

Enhancing the Outcome of Skills Training for People With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social skills and symptom management training
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Psychotic Disorders

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hall-Brooke-The Center
  • Hall-Brooke Behavioral Health Services

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 24, 2003
Last Updated
September 23, 2013
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT00069433
Brief Title
Enhancing the Outcome of Skills Training for People With Schizophrenia
Official Title
Skills Training for Schizophrenia: Enhancing Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Psychotic Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Social skills and symptom management training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hall-Brooke-The Center
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Hall-Brooke Behavioral Health Services
City
Westport
State/Province
Connecticut
ZIP/Postal Code
06880
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Enhancing the Outcome of Skills Training for People With Schizophrenia

We'll reach out to this number within 24 hrs