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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
  Purpose

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


Condition Intervention
Schizophrenia
 Behavioral: Cognitive Remediation
Behavioral: Computer-skills training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Treatment Response to Rehabilitation in Schizophrenia

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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 ]

Enrollment: 46
Study Start Date: December 2001
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive cognitive remediation treatment.
 Behavioral: Cognitive Remediation
A computerized cognitive rehabilitation treatment with day-program activities
Experimental: 2
Participants will receive computer-skills training.
 Behavioral: Computer-skills training
A computerized cognitive rehabilitation treatment with day-program activities

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00063336

Locations
United States, Connecticut
Schizophrenia Rehabilitation Program, Institutes of Living
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Matthew M. Kurtz, PhD Schizophrenia Rehabilitation Program, Institutes of Living
  More Information

No publications provided

Responsible Party: Matthew M. Kurtz, PhD, Schizophrenia Rehabilitation Program, Institutes of Living
ClinicalTrials.gov Identifier: NCT00063336     History of Changes
Other Study ID Numbers: R03 MH065377, DSIR AT-SP
Study First Received: June 25, 2003
Last Updated: May 4, 2009
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on May 21, 2013