Clinical trial NCT00295048: Cognitive Remediation for Schizophrenia
Official title: Cognitive Remediation for Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: treatment
cognition
schizophrenia
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: VISN 5 Mental Illness Research, Education and Clinical Center
First posted: 2006-02-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of an innovative, computer driven cognitive rehabilitation program for individuals with schizophrenia and related disorders.

Detailed description: Schizophrenia is associated with neurocognitive impairment, diminished life satisfaction, lack of independence, and poor functioning in social, occupational and other desired and expected community roles. The personal, social and economic costs of this illness are enormous. Neurocognitive deficits (e.g., slowed thinking, poor attention and memory, inadequate problem solving) are now recognized as core features of the illness, and primary contributors to functional impairment among patients (Bellack, Gold \& Buchanan; 1999; Green, 1996). While standard antipsychotic medications improve psychotic symptomatology in many patients, their impact on neurocognition is modest, at best, and dramatic functional deficits remain even after adequate pharmacological treatment (Keefe et al., 1999). Hence, there is growing interest in alternative treatment strategies to address cognitive deficits, including computer-assisted cognitive remediation.

The purpose of this project is to assess the efficacy of a computer-assisted cognitive remediation program we have developed: Computer Assisted Cognitive Remediation (CACR). Fifty individuals with schizophrenia and related disorders 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 behavioral performance in three dimensions: (1) on the trained learning exercises, (2) on neuropsychological measures, and (3) on role play based assessments of everyday problem solving. We hypothesize that CACR will be more effective than the control treatment in each domain.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of either schizophrenia or schizoaffective disorder according to DSM-IV criteria
2. Age 18 through 50
3. Subjects will be clinically stable as judged by current outpatient or inpatient treatment staff
4. Primary psychiatric medication is a new generation antipsychotic other than Clozapine and/or a dose of first generation antipsychotic equivalent to 10 mg. of less of haloperidol for one month prior to enrollment.

Exclusion Criteria:

1. Documented history of organic brain disease
2. Documented history of mental retardation
3. Physical limitations (e.g., with hearing or vision) that would interfere substantially with use of computer-based exercises
4. Diagnosis of current Substance Dependence according to DSM-IV criteria
5. Participation in the prior full trial of this remediation program (this exclusion is meant to apply to individuals participating in the full controlled trial, and not to individuals participating in the preliminary sub-study).

Primary outcomes:
measure: broad cognitive performance (as indexed by a composite of the neuropsychological measures) and on a composite of everyday problem solving
Secondary outcomes:
measure: individual cognitive domains and individual everyday problem solving domains, the interaction of treatment with various other variables
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland - Walter P. Carter Center
state: Maryland
city: Baltimore
country: United States
facility: VA Maryland Health Care Systen
state: Maryland
city: Catonsville
country: United States
facility: MOSAIC Community Services
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Dwight Dickinson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.