Evaluating Two Types of Cognitive Training in Veterans With Schizophrenia

NCT01891721 | Completed Results

• 1 other identifier: MHBB-015-12F
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

Brief Summary

Cognitive dysfunction is a major contributor to the poor community outcome of individuals with schizophrenia. Developing more effective cognitive remediation interventions is imperative to improve the daily lives of affected subjects and reduce the disability of this illness. The goal of this clinical trial is to evaluate two types of cognitive training approaches to determine which one is more beneficial for individuals with schizophrenia. This study also uses electrophysiological techniques to gain a better understanding of the mechanisms involved in cognitive remediation. Findings from this study will provide information about how to design the most optimally efficient cognitive training intervention to improve the cognitive and social functioning of patients with severe mental illness.

Conditions

Schizophrenia

Keywords

cognitive training; schizophrenia; mismatch negativity; cognition; functional capacity; EEG

Outcome Measures

Primary Outcomes (1)

• Neurocognition

  The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) was used to assess basic cognition. It includes tests representing 6 separable cognitive domains. The MCCB composite score (average of 6 domain t-scores) served as the primary cognitive outcome measure. Minimum and maximum values are 20 and 68. Higher scores mean a better outcome.

  Within one week of training completion

Secondary Outcomes (2)

• Electroencephalography (EEG)

  After 6 weeks of training and within one week of training completion

• Functional Capacity

  Within one week of training completion

Study Arms (3)

Specific Perceptual Training - Brain Fitness Program (BFP)

EXPERIMENTAL

In each session, participants will work on 4 of the 6 BFP exercises (15 min per exercise). Duration of training is 1 hour per day, 3 days per week, for 12 weeks, for a total of 36 hours.

Behavioral: Brain Fitness Program (BFP)

Broad Cognitive Training - Cognitive Package (Cogpack)

EXPERIMENTAL

In each session, participants will work on a different subset of 4 to 6 Cogpack exercises. Duration of training is 1 hour per day, 3 days per week, for 12 weeks, for a total of 36 hours.

Behavioral: Cognitive Package (Cogpack)

Control Treatment - Commercial Computer Games (Sporcle)

ACTIVE COMPARATOR

In each session, participants will play between 8 and 16 games (1 to 15 min per game). Duration of training is 1 hour per day, 3 days per week, for 12 weeks, for a total of 36 hours.

Behavioral: Commercial Computer Games (Sporcle)

Interventions

Brain Fitness Program (BFP) BEHAVIORAL

This computerized "bottom-up" cognitive intervention is designed to improve the speed and accuracy of auditory information processing through increasingly more difficult stimulus recognition, discrimination, sequencing, and memory tasks under conditions of close attentional control, high reward, and novelty. BFP consists of 6 exercises. Stimuli across the exercises are chosen such that they span the acoustic and organizational structure of speech, from very simple acoustic stimuli and tasks to complex manipulations of continuous speech. The exercises adaptively progress based on the subject's individual performance during a training session and become more challenging as the subject's abilities improve. Participants will work with 4 of the 6 exercises (15 min per exercise) in each session.

Specific Perceptual Training - Brain Fitness Program (BFP)

Cognitive Package (Cogpack) BEHAVIORAL

This computerized "top-down" cognitive intervention is designed to provide training across a broad range of cognitive functions. Cogpack consists of domain-specific exercises aimed at training specific cognitive areas (attention, working memory, verbal and visual memory, executive functioning, reasoning, language) and non-domain-specific exercises that require the use of several functions at a time. Cogpack includes low-level cognitive exercises (i.e., scanning, hand-eye coordination, and psychomotor speed) that will not be included in this protocol to better separate bottom-up from top-down training interventions. There will be a total of 34 exercises and variants of the same exercises with different levels of difficulty. In each session, participants will work on a different subset of 4 to 6 exercises.

Broad Cognitive Training - Cognitive Package (Cogpack)

Commercial Computer Games (Sporcle) BEHAVIORAL

Sporcle computer games will be used as a "placebo" treatment to control for the effects of computer exposure, contact with research personnel, time spent being cognitively active, and financial compensation for participation. The games cover trivia-type questions about geography, entertainment, science, history, literature, sports, movies, etc. Subjects will receive the same amount of attention from staff members and the same monetary reinforcements as participants in the experimental treatment groups. They will also complete 3 hours of "training" per week over 12 weeks, for a total of 36 hours.

Control Treatment - Commercial Computer Games (Sporcle)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans with a Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder
• Between 25 and 65 years of age
• Estimated premorbid inteIligence quotient (IQ) \> 70 (based on reading ability)
• Understand spoken English sufficiently to comprehend the consent form
• Clinically stable (i.e., no inpatient hospitalization in the 3 months, no changes in psychiatric medications in the 6 weeks, and no changes in housing in the 2 months, prior to enrollment)

You may not qualify if:

• Documented history of mental retardation or severe learning disability
• Clinically significant neurological disease as determined by medical history (e.g., epilepsy, stroke)
• History of serious head injury with loss of consciousness greater than 1 hour and concomitant neuropsychological sequelae
• Meeting DSM-IV criteria for drug or alcohol dependence during the 6 months, or abuse during the month preceding study enrollment

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Local Board and Care Facilities

Los Angeles, California, 90073, United States

Location

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

Related Publications (6)

• Adcock RA, Dale C, Fisher M, Aldebot S, Genevsky A, Simpson GV, Nagarajan S, Vinogradov S. When top-down meets bottom-up: auditory training enhances verbal memory in schizophrenia. Schizophr Bull. 2009 Nov;35(6):1132-41. doi: 10.1093/schbul/sbp068. Epub 2009 Sep 10.

  PMID: 19745022 BACKGROUND

• Medalia A, Choi J. Cognitive remediation in schizophrenia. Neuropsychol Rev. 2009 Sep;19(3):353-64. doi: 10.1007/s11065-009-9097-y. Epub 2009 May 15.

  PMID: 19444614 BACKGROUND

• Popov T, Jordanov T, Rockstroh B, Elbert T, Merzenich MM, Miller GA. Specific cognitive training normalizes auditory sensory gating in schizophrenia: a randomized trial. Biol Psychiatry. 2011 Mar 1;69(5):465-71. doi: 10.1016/j.biopsych.2010.09.028. Epub 2010 Nov 18.

  PMID: 21092939 BACKGROUND

• Green MF, Kern RS, Braff DL, Mintz J. Neurocognitive deficits and functional outcome in schizophrenia: are we measuring the "right stuff"? Schizophr Bull. 2000;26(1):119-36. doi: 10.1093/oxfordjournals.schbul.a033430.

  PMID: 10755673 BACKGROUND

• Fisher M, Holland C, Merzenich MM, Vinogradov S. Using neuroplasticity-based auditory training to improve verbal memory in schizophrenia. Am J Psychiatry. 2009 Jul;166(7):805-11. doi: 10.1176/appi.ajp.2009.08050757. Epub 2009 May 15.

  PMID: 19448187 BACKGROUND

• Light GA, Braff DL. Mismatch negativity deficits are associated with poor functioning in schizophrenia patients. Arch Gen Psychiatry. 2005 Feb;62(2):127-36. doi: 10.1001/archpsyc.62.2.127.

  PMID: 15699289 BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Carol Jahchan
• Organization: VA Greater Los Angeles Healthcare System

carol.jahchan@va.gov

310-478-3711

Study Officials

• Carol Jahchan, PhD

  VA Greater Los Angeles Healthcare System, West Los Angeles, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: July 3, 2013
• Study Start: November 21, 2013
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: August 14, 2019
• Results First Posted: August 14, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)