ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment Response to Rehabilitation in Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00063336
Recruitment Status : Completed
First Posted : June 27, 2003
Last Update Posted : November 8, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
Hartford Hospital

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

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Cognitive Remediation Behavioral: Computer-skills training Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Treatment Response to Rehabilitation in Schizophrenia
Study Start Date : December 2001
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Neuropsychological test battery, including measures of visual, verbal memory, and problem-solving abilities [ Time Frame: Measured pre- and post-treatment ]
  2. Schizophrenia symptoms [ Time Frame: Measured pre- and post-treament ]
  3. UCSD Performance-Based Skills Assessment [ Time Frame: Measured pre- and post-treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00063336


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

Responsible Party: Matthew M. Kurtz, PhD, Schizophrenia Rehabilitation Program, Institutes of Living
ClinicalTrials.gov Identifier: NCT00063336     History of Changes
Other Study ID Numbers: R03MH065377 ( U.S. NIH Grant/Contract )
DSIR AT-SP
First Posted: June 27, 2003    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: May 2009

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders