Treatment Response to Rehabilitation in Patients With Schizophrenia

This study has been completed.

Sponsor:

Information provided by:

National Institute of Mental Health (NIMH)

ClinicalTrials.gov Identifier:

NCT00063336

First received: June 25, 2003

Last updated: May 4, 2009

Last verified: May 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

June 25, 2003

Last Updated Date

May 4, 2009

Start Date ^ICMJE

December 2001

Primary Completion Date

November 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Neuropsychological test battery, including measures of visual, verbal memory, and problem-solving abilities [ Time Frame: Measured pre- and post-treatment ] [ Designated as safety issue: No ]
Schizophrenia symptoms [ Time Frame: Measured pre- and post-treament ] [ Designated as safety issue: No ]
UCSD Performance-Based Skills Assessment [ Time Frame: Measured pre- and post-treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00063336 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Treatment Response to Rehabilitation in Patients With Schizophrenia

Official Title ^ICMJE

Treatment Response to Rehabilitation in Schizophrenia

Brief Summary

This study will examine the ways in which schizophrenia-related symptoms affect response to a rehabilitation program for people with schizophrenia.

Detailed Description

Patients with schizophrenia often suffer neurocognitive impairment and psychosocial and vocational difficulties. This study will help identify those patients most likely to benefit from existing behavioral treatments and provide clues for how to modify treatments for those who do not benefit.

Two studies will be conducted. The first will investigate the relationship of symptoms and neurocognitive variables at study entry to psychosocial and vocational status 2 years later. The second study will investigate the relationship of symptoms and neurocognitive variables at study entry to treatment response in patients assigned to either a cognitive remediation track or a computer skills track as part of their rehabilitation treatment.

Both the cognitive remediation and computer skills training programs will last 4 to 6 months. Participants will be assessed pre- and post-treatment. Neuropsychological, psychosocial and vocational status will be measured.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Behavioral: Cognitive Remediation
A computerized cognitive rehabilitation treatment with day-program activities
Behavioral: Computer-skills training
A computerized cognitive rehabilitation treatment with day-program activities

Study Arm (s)

Experimental: 1
Participants will receive cognitive remediation treatment.

Intervention: Behavioral: Cognitive Remediation
Experimental: 2
Participants will receive computer-skills training.

Intervention: Behavioral: Computer-skills training

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2005

Primary Completion Date

November 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

DSM-IV criteria for schizophrenia or schizoaffective disorder
In need of intensive outpatient care
Treatment with atypical antipsychotic medication for a minimum of 6 months prior to study entry

Exclusion Criteria:

Auditory or visual impairment
Mental retardation (IQ less than 70)
Traumatic brain injury with loss of consciousness
Presence or history of any neurological illness that may affect brain physiology
Lack of proficiency in English
Concurrent substance abuse and/or dependence

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00063336

Other Study ID Numbers ^ICMJE

R03 MH065377, DSIR AT-SP

Has Data Monitoring Committee

Not Provided

Responsible Party

Matthew M. Kurtz, PhD, Schizophrenia Rehabilitation Program, Institutes of Living

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Matthew M. Kurtz, PhD

Schizophrenia Rehabilitation Program, Institutes of Living

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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