Neurophysiological Targets for Cognitive Training in Schizophrenia

NCT ID: NCT00923078

Last Updated: 2017-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-10-31

Brief Summary

The purpose of this study is to determine whether computer-based training of auditory and visual processing results in corresponding improvement in brain function in individuals with schizophrenia.

Detailed Description

Schizophrenia is recognized as one of the leading causes of medical disability worldwide, ranked 9th overall by the World Health Organization, and affects more than 2 million Americans per year. There is considerable evidence to suggest that disability status in schizophrenia relates more directly to cognitive Impairment, involving attention, reasoning, and memory, than to characteristic symptoms of psychosis. Accordingly, the evaluation and advancement of interventions designed to restore cognitive function, generally termed cognitive remediation, is of critical importance to our rehabilitation mission. Recent randomized controlled trials of cognitive remediation in schizophrenia have found moderate gains in cognitive function and improved outcomes in important areas of community living. However, despite these encouraging findings, there remains sparse evidence in support of assumptions that (1) cognitive outcomes represent benefits of training-induced adaptive learning, (2) that training effects are specific to method of intervention, or (3) that change in cognitive test performance occurs through restoration of impaired neural circuitry in schizophrenia. This project will begin to address these issues by examining modality-specific effects of computer-based cognitive training on psychophysiological measures of sensory information processing. Training will be administered using two commercially available computer-based software packages, separately targeting auditory and visually-mediated processes using principles of bottom-up perceptual learning. Two psychophysiological paradigms, mismatch negativity (MMN) and P300 generation, will be administered as tests of early visual and auditory processing. MMN and P300 have been studied extensively in human neuroscience as probes of sensory echoic memory and attention engagement to contextually relevant information. Furthermore, reductions in MMN and P300 generation are reliably observed in schizophrenia, follow the course of a progressive neuropathological process, and correlate with severity of cognitive impairment. The specific aims of this study are to determine: (1) whether training selectively influences bottom-up (MMN) or top-down (P300) information processing, (2) whether training effects are modality (auditory vs. visual) specific, (3) whether baseline MMN and P300 predict, or rate-limit, training progress, and (4) whether pre-post change in cognitive test performance is mediated by neural-level change in MMN and P300 generation. Answers to these questions will provide information needed to structure cognitive training for maximum benefit in schizophrenia.

Conditions

Schizophrenia

Keywords

schizophrenia; cognitive remediation; rehabilitation; electrophysiology; neuropsychology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Auditory-Visual Train Order

4 weeks (20 sessions) of auditory cognitive training (Brain Fitness) followed by 4 weeks (20 sessions) of visual cognitive training (Insight)

Group Type: EXPERIMENTAL

Auditory Cognitive Training

Intervention Type: BEHAVIORAL

The program entails six computer-based exercises that are designed to be very easy to use and require no computer experience. The exercises are calibrated to individual performance at the onset of training and adapt in difficulty to individual performance, giving constant feedback about progress. Each of the six exercises focuses on a distinct process: (1) auditory processing speed, (2) discriminating sounds, (3) sound precision, (4) sound sequencing, (5) working memory, and (6) narrative memory. Training was administered in a supervised clinical laboratory setting at a frequency of five 60-minute sessions per week over 4 weeks.

Visual Cognitive Training

Intervention Type: BEHAVIORAL

The program entails five computer-based exercises that are designed to be very easy to use and require no computer experience. The exercises are calibrated to individual performance at the onset of training and, following our laboratory procedures, calibration testing is repeated every 5th session. Exercises adapt in difficulty to individual performance, giving constant feedback about progress. Each of the five exercises focuses on a distinct process: (1) visual precision, (2) visual processing speed, (3) divided attention, (4) visual working memory, and (5) useful field of view. Training was administered in a supervised clinical laboratory setting at a frequency of five 40-minute sessions per week over 4 weeks.

Visual-Auditory Train Order

4 weeks (20 sessions) of visual cognitive training (Insight) followed by 4 weeks (20 sessions) of auditory cognitive training (Brain Fitness)

Group Type: EXPERIMENTAL

Auditory Cognitive Training

Intervention Type: BEHAVIORAL

The program entails six computer-based exercises that are designed to be very easy to use and require no computer experience. The exercises are calibrated to individual performance at the onset of training and adapt in difficulty to individual performance, giving constant feedback about progress. Each of the six exercises focuses on a distinct process: (1) auditory processing speed, (2) discriminating sounds, (3) sound precision, (4) sound sequencing, (5) working memory, and (6) narrative memory. Training was administered in a supervised clinical laboratory setting at a frequency of five 60-minute sessions per week over 4 weeks.

Visual Cognitive Training

Intervention Type: BEHAVIORAL

The program entails five computer-based exercises that are designed to be very easy to use and require no computer experience. The exercises are calibrated to individual performance at the onset of training and, following our laboratory procedures, calibration testing is repeated every 5th session. Exercises adapt in difficulty to individual performance, giving constant feedback about progress. Each of the five exercises focuses on a distinct process: (1) visual precision, (2) visual processing speed, (3) divided attention, (4) visual working memory, and (5) useful field of view. Training was administered in a supervised clinical laboratory setting at a frequency of five 40-minute sessions per week over 4 weeks.

Interventions

Auditory Cognitive Training

The program entails six computer-based exercises that are designed to be very easy to use and require no computer experience. The exercises are calibrated to individual performance at the onset of training and adapt in difficulty to individual performance, giving constant feedback about progress. Each of the six exercises focuses on a distinct process: (1) auditory processing speed, (2) discriminating sounds, (3) sound precision, (4) sound sequencing, (5) working memory, and (6) narrative memory. Training was administered in a supervised clinical laboratory setting at a frequency of five 60-minute sessions per week over 4 weeks.

Intervention Type: BEHAVIORAL

Visual Cognitive Training

The program entails five computer-based exercises that are designed to be very easy to use and require no computer experience. The exercises are calibrated to individual performance at the onset of training and, following our laboratory procedures, calibration testing is repeated every 5th session. Exercises adapt in difficulty to individual performance, giving constant feedback about progress. Each of the five exercises focuses on a distinct process: (1) visual precision, (2) visual processing speed, (3) divided attention, (4) visual working memory, and (5) useful field of view. Training was administered in a supervised clinical laboratory setting at a frequency of five 40-minute sessions per week over 4 weeks.

Intervention Type: BEHAVIORAL

Other Intervention Names

Brain Fitness by Posit Science; Cortex with Insight by Posit Science

Eligibility Criteria

Inclusion Criteria

• DSM-IV diagnosis of schizophrenia or schizoaffective disorder
• Age between 18 & 70
• minimum of 30 days since discharge from last hospitalization
• minimum of 30 days since last change in psychiatric medications
• receiving mental health services
• no housing changes in the past 30 days

Exclusion Criteria

• current diagnosis of alcohol or substance abuse
• history of brain trauma or neurological disease
• chart diagnosis of mental retardation or premorbid intelligence < 70 based on Wechsler Test of Adult Reading (WTAR) full-scale estimated IQ
• auditory or visual impairment that would interfere with study procedures

• a sample of 20 healthy community volunteers was also recruited according to these criteria and tested, without intervention, as a normative reference sample for MMN and P300 measures

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason K Johannesen, 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

D7008-W

Identifier Type: -

Identifier Source: org_study_id