Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Cognitive Remediation for Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00261794
First received: December 1, 2005
Last updated: January 5, 2010
Last verified: January 2010

December 1, 2005
January 5, 2010
November 2004
June 2007   (final data collection date for primary outcome measure)
cognitive performance and every day problem solving [ Time Frame: post-treatment and 3-month follow-up ] [ Designated as safety issue: No ]
Cognitive performance and every day problem solving at baseline, post treatment and 3-month follow-up period.
Complete list of historical versions of study NCT00261794 on ClinicalTrials.gov Archive Site
Not Provided
Vocation-relevant outcomes and subjective cognitive performance at baseline, post treatment and 3-month follow-up period.
Not Provided
Not Provided
 
Cognitive Remediation for Schizophrenia
Computer Assisted Cognitive Remediation for Schizophrenia

The purpose of this study is to evaluate the efficacy of an innovative, computer driven cognitive rehabilitation program for unemployed veterans with schizophrenia.

Schizophrenia leads to a striking array of negative outcomes, including profound deficits in the ability to fulfill desired and expected community roles. Chronic under employment and unemployment are among the most serious of these consequences. VA treats over 100,000 veterans with schizophrenia spectrum disorders, the majority of whom are unable to work competitively and do not participate in VA vocational rehabilitation programs despite the fact that VA is committed to enhancing the ability of these veterans to work. Within VA, a major vehicle for helping veterans to become employed is the Compensated Work Therapy (CWT) program, yet in FY2001 only 800 of the roughly 14000 veterans treated in CWT had SMI diagnoses, and only a subset of those 800 had schizophrenia. A number of factors contribute to low participation in vocational rehabilitation and poor work outcomes, but recent data suggest that one of the most important is cognitive impairment. People with schizophrenia have significant deficits in multiple areas of neurocognition, including secondary and working memory, attention, and executive functioning. These impairments have been shown to play a major role in functional outcome, including the ability to benefit from rehabilitation and to work. As a result, there has been increasing interest in the potential for improving neurocognitive functioning via cognitive rehabilitation. While several programs have yielded promising data, currently there is no empirically validated approach.The purpose of this project is to evaluate the efficacy of an innovative, computer driven cognitive rehabilitation program we have developed: Computer Assisted Cognitive Remediation (CACR). Veterans with schizophrenia who are unemployed and not participating in vocational rehabilitation will be recruited and randomly assigned to one of two conditions: a) 36 sessions of CACR; or b) 36 sessions of a manualized computer control condition (RC). The efficacy of CACR will be assessed on a range of outcome domains, including neuropsychological test, measures of every day and social problem solving, self-reported cognitive functioning and self-efficacy, and work readiness. All subjects will be referred to CWT at the conclusion of treatment and we will assess how many receive work assignments, and work performance (over 3-months) of those who begin work. We hypothesize that CACR will be more effective than the control treatment in each domain.The results of this project could have important implications for treatment of veterans with schizophrenia. CACR is a manualized program that can be administered by BA level staff. If demonstrated to be efficacious, it could be disseminated throughout VA and have a beneficial impact on vocational outcomes and the quality of life of veterans with schizophrenia.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Behavioral: computer-assisted cognitive remediation (CACR)
    36 individual computer sessions with a staff clinician. computer activities consist of commercially available educational software designed for use in the classroom.
    Other Name: CACR
  • Behavioral: manualized computer control condition (RC).
    36 sessions of a manualized computer control condition.
    Other Name: RC
  • Experimental: 1
    computer-assisted cognitive remediation (CACR)
    Intervention: Behavioral: computer-assisted cognitive remediation (CACR)
  • Active Comparator: 2
    computer-based cognitive activity
    Intervention: Behavioral: manualized computer control condition (RC).

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
September 2007
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Current DSM-IV diagnoses of schizophrenia or schizoaffective disorder
  2. Stable clinical course and antipsychotic treatment on a new generation antipsychotic other than clozapine and/or a dose of first generation antipsychotic equivalent to 10 mg. or less of haloperidol for one month prior to enrollment
  3. Age between 18 and 64 years
  4. Voluntary consent after receiving full information about the study

Exclusion Criteria:

  1. Documented history of neurological disorder or significant head trauma with extended loss of consciousness
  2. Physical limitations (e.g., with hearing or vision) that would interfere substantially with the use of computer-based exercises
  3. Current treatment with a first generation antipsychotic medication at a dose equivalent to more than 10 mg. of haloperidol
  4. Current treatment with benztropine mesylate at a daily does greater than 4 mg
  5. Current treatment with trihexyphenidyl at a daily dose greater than 15 mg
  6. Current treatment that combines benztropine mesylate with trihexyphenidyl
  7. Current treatment with diphenhydramine
  8. Current competitive employment or participation (current or within past 3 months) in a program designed to secure competitive employment (e.g., CWT)
  9. Mini Mental Status Examination (MMSE) score of less than 23
  10. Diagnosis of current Substance Dependence according to DSM-IV criteria
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00261794
D3153R
Not Provided
Bellack, Alan - Principal Investigator, Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Alan S. Bellack, PhD VA Maryland Health Care System, Baltimore
Department of Veterans Affairs
January 2010

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