Predictors of Response to Cognitive Remediation in Schizophrenia

NCT ID: NCT00333970

Last Updated: 2014-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2014-07-31

Brief Summary

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

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

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

cognitive remediation

cognitive remediation

Group Type: EXPERIMENTAL

cognitive remediation

Intervention Type: BEHAVIORAL

individual cognitive training

treatment as usual

treatment as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

cognitive remediation

individual cognitive training

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joanna Fiszdon, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Connecticut Health Care System (West Haven)

Locations

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, United States

Countries

United States

Other Identifiers

JMF0001

Identifier Type: OTHER

Identifier Source: secondary_id

F3460-V

Identifier Type: -

Identifier Source: org_study_id