Predictors of Response to Cognitive Remediation in Schizophrenia

October 6, 2014 updated by: US Department of Veterans Affairs
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Health Care System (West Haven)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cognitive remediation
Behavioral: cognitive remediation
individual cognitive training
No Intervention: treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Performance
Time Frame: baseline and 2 months
Change in verbal memory scores from baseline to end of active phase (2 months), measured as trials 1-5 total score on the California Verbal Learning Test -II (range 0-80, higher scores represent better performance).
baseline and 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Joanna Fiszdon, PhD, VA Connecticut Health Care System (West Haven)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

June 2, 2006

First Submitted That Met QC Criteria

June 2, 2006

First Posted (Estimate)

June 6, 2006

Study Record Updates

Last Update Posted (Estimate)

October 9, 2014

Last Update Submitted That Met QC Criteria

October 6, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F3460-V
  • JMF0001 (Other Identifier: VACHS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on cognitive remediation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe