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CompletedNCT00261794Updated Jan 6, 2010

Cognitive Remediation for Schizophrenia

An interventional study of computer-assisted cognitive remediation (CACR) and manualized computer control condition (RC). in Schizophrenia, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2010-01-06.

Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
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Study summary

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

Read the detailed description

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.

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Conditions studied

  • Schizophrenia

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Keywords

  • cognition
  • schizophrenia
  • treatment
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In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 90 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    1

    computer-assisted cognitive remediation (CACR)

    Behavioral: computer-assisted cognitive remediation (CACR)

  • Active comparator
    2

    computer-based cognitive activity

    Behavioral: manualized computer control condition (RC).

Interventions

  • Behavioralcomputer-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.

    Also known as: CACR

  • Behavioralmanualized computer control condition (RC).

    36 sessions of a manualized computer control condition.

    Also known as: RC

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What researchers measure

Primary outcomes

  1. cognitive performance and every day problem solving

    Time frame: post-treatment and 3-month follow-up

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Study locations

1 site
  • VA Maryland Health Care System, Baltimore
    Baltimore, Maryland 21201, United States
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References and documents

Publications

  • Bellack AS, Gold JM, Buchanan RW. Cognitive rehabilitation for schizophrenia: problems, prospects, and strategies. Schizophr Bull. 1999;25(2):257-74. doi: 10.1093/oxfordjournals.schbul.a033377. PubMed 10416730 ↗
  • Bellack AS. Skills training for people with severe mental illness. Psychiatr Rehabil J. 2004 Spring;27(4):375-91. doi: 10.2975/27.2004.375.391. PubMed 15222149 ↗
  • Dickinson D, Tenhula W, Morris S, Brown C, Peer J, Spencer K, Li L, Gold JM, Bellack AS. A randomized, controlled trial of computer-assisted cognitive remediation for schizophrenia. Am J Psychiatry. 2010 Feb;167(2):170-80. doi: 10.1176/appi.ajp.2009.09020264. Epub 2009 Dec 15. PubMed 20008941 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00261794
Lead sponsor
US Department of Veterans Affairs
First posted
Dec 5, 2005
Start date
Nov 2004
Primary completion
Jun 2007
Completion
Sep 2007
Last update
Jan 6, 2010

Study contacts

Alan S. Bellack, PhD
principal investigator · VA Maryland Health Care System, Baltimore
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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