Enhancing the Outcome of Skills Training for People With Schizophrenia

NCT ID: NCT00069433

Last Updated: 2013-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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

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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

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Schizophrenia

Keywords

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Psychotic Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Social skills and symptom management training

Intervention Type PROCEDURE

Eligibility Criteria

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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

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hall-Brooke-The Center

Bridgeport, Connecticut, United States

Site Status

Hall-Brooke Behavioral Health Services

Westport, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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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