Predictors of Response to Cognitive Remediation in Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00333970
First received: June 2, 2006
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to determine which variables predict improvement on a cognitive training task battery, used for patients with schizophrenia, and to determine the proportion of patients whose performance returns to normal following cognitive training


Condition Intervention
Schizophrenia
Behavioral: cognitive remediation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Predictors of Response to Cognitive Remediation in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • cognitive performance [ Time Frame: 2 months from baseline and 4 months from baseline ] [ Designated as safety issue: No ]
    neuropsychological and psychiatric assessments


Enrollment: 103
Study Start Date: August 2004
Study Completion Date: July 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
cognitive remediation
Behavioral: cognitive remediation
individual cognitive training
No Intervention: Arm 2
treatment as usual

Detailed Description:

It has been suggested that level of cognitive function is a "rate-limiter" for the efficacy of other psychosocial treatments in schizophrenia. Cognitive remediation, which entails training and practice of successively more difficult cognitive exercises, has shown efficacy in improving cognitive function. However, the rate of improvement has not been uniform among patients receiving this intervention. Given the time- and cost-intensiveness of cognitive remediation, it is important to examine variables that will predict response to this treatment, as well as to examine the clinical significance of any improvement.

The current proposal has two aims: 1) to determine which neuropsychological, demographic, and illness variables predict response to cognitive remediation training; and 2) to determine the proportion of patients whose performance returns to normal following cognitive remediation training. For the first part of the proposed study, 50 outpatients diagnosed with schizophrenia spectrum disorders will be invited to participate in an 8-week trial of cognitive remediation training. Detailed neuropsychological, demographic, symptom and illness course variables will be collected prior to training, at the conclusion of training, and 4 months from study intake. In order to answer the second question, additional data on the computerized task performance for healthy controls will be collected, and compared to patient data, in order to determine what constitutes normal-range performance

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia spectrum disorder
  • English speakers
  • Clinically stable
  • No substance abuse in past 30 days

Exclusion Criteria:

  • Traumatic brain injury
  • Neurological disease
  • Diagnosis of mental retardation
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00333970

Locations
United States, Connecticut
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Investigators
Principal Investigator: Joanna Fiszdon, PhD VA Connecticut Health Care System (West Haven)
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00333970     History of Changes
Other Study ID Numbers: F3460-V, JMF0001
Study First Received: June 2, 2006
Last Updated: July 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
cognition
neuropsychology
Rehabilitation
treatment efficacy
cognitive remediation

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on October 01, 2014