Treatment Response to Rehabilitation in Patients With Schizophrenia

November 7, 2013 updated by: Hartford Hospital

Treatment Response to Rehabilitation in Schizophrenia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Schizophrenia Rehabilitation Program, Institutes of Living

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neuropsychological test battery, including measures of visual, verbal memory, and problem-solving abilities
Time Frame: Measured pre- and post-treatment
Measured pre- and post-treatment
Schizophrenia symptoms
Time Frame: Measured pre- and post-treament
Measured pre- and post-treament
UCSD Performance-Based Skills Assessment
Time Frame: Measured pre- and post-treatment
Measured pre- and post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hartford Hospital

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Matthew M. Kurtz, PhD, Schizophrenia Rehabilitation Program, Institutes of Living

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

June 25, 2003

First Submitted That Met QC Criteria

June 26, 2003

First Posted (Estimate)

June 27, 2003

Study Record Updates

Last Update Posted (Estimate)

November 8, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

May 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R03MH065377 (U.S. NIH Grant/Contract)
  • DSIR AT-SP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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