NCT00261794

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

January 6, 2010

Status Verified

January 1, 2010

Enrollment Period

2.6 years

First QC Date

December 1, 2005

Last Update Submit

January 5, 2010

Conditions

Schizophrenia

Keywords

cognitionschizophreniatreatment

Outcome Measures

Primary Outcomes (1)

  • cognitive performance and every day problem solving

    post-treatment and 3-month follow-up

Study Arms (2)

1

EXPERIMENTAL

computer-assisted cognitive remediation (CACR)

Behavioral: computer-assisted cognitive remediation (CACR)

2

ACTIVE COMPARATOR

computer-based cognitive activity

Behavioral: manualized computer control condition (RC).

Interventions

computer-assisted cognitive remediation (CACR)BEHAVIORAL

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
1
manualized computer control condition (RC).BEHAVIORAL

36 sessions of a manualized computer control condition.

Also known as: RC
2

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Current DSM-IV diagnoses of schizophrenia or schizoaffective disorder
  • 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
  • Age between 18 and 64 years
  • Voluntary consent after receiving full information about the study

You may not qualify if:

  • Documented history of neurological disorder or significant head trauma with extended loss of consciousness
  • Physical limitations (e.g., with hearing or vision) that would interfere substantially with the use of computer-based exercises
  • Current treatment with a first generation antipsychotic medication at a dose equivalent to more than 10 mg. of haloperidol
  • Current treatment with benztropine mesylate at a daily does greater than 4 mg
  • Current treatment with trihexyphenidyl at a daily dose greater than 15 mg
  • Current treatment that combines benztropine mesylate with trihexyphenidyl
  • Current treatment with diphenhydramine
  • Current competitive employment or participation (current or within past 3 months) in a program designed to secure competitive employment (e.g., CWT)
  • Mini Mental Status Examination (MMSE) score of less than 23
  • Diagnosis of current Substance Dependence according to DSM-IV criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, 21201, United States

Location

Related Publications (3)

  • 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.

    PMID: 10416730RESULT

  • 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.

    PMID: 15222149RESULT

  • 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.

    PMID: 20008941RESULT

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Alan S. Bellack, PhD

    VA Maryland Health Care System, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

December 1, 2005

First Posted

December 5, 2005

Study Start

November 1, 2004

Primary Completion

June 1, 2007

Study Completion

September 1, 2007

Last Updated

January 6, 2010

Record last verified: 2010-01

Locations

US(1)