Trial Outcomes & Findings for Evaluating Two Types of Cognitive Training in Veterans With Schizophrenia (NCT NCT01891721)

NCT ID: NCT01891721

Last Updated: 2019-08-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

105 participants

Primary outcome timeframe

Within one week of training completion

Results posted on

2019-08-14

Participant Flow

6 participants were excluded from the study before being randomized to groups: 4 for not meeting inclusion criteria and 2 for not wanting to participate.

Participant milestones

Participant milestones
Measure
Specific Perceptual Training - Brain Fitness Program (BFP)
In each session, participants worked 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. Brain Fitness Program (BFP): 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.
Broad Cognitive Training - Cognitive Package (Cogpack)
In each session, participants worked 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. Cognitive Package (Cogpack): 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, 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.
Control Treatment - Commercial Computer Games (Sporcle)
In each session, participants played 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. Commercial Computer Games (Sporcle): Sporcle computer games were 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 received the same amount of attention from staff members and the same monetary reinforcements as participants in the experimental treatment groups. They also completed 3 hours of "training" per week over 12 weeks, for a total of 36 hours.
Overall Study
STARTED
39
40
20
Overall Study
COMPLETED
29
35
19
Overall Study
NOT COMPLETED
10
5
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Specific Perceptual Training - Brain Fitness Program (BFP)
In each session, participants worked 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. Brain Fitness Program (BFP): 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.
Broad Cognitive Training - Cognitive Package (Cogpack)
In each session, participants worked 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. Cognitive Package (Cogpack): 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, 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.
Control Treatment - Commercial Computer Games (Sporcle)
In each session, participants played 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. Commercial Computer Games (Sporcle): Sporcle computer games were 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 received the same amount of attention from staff members and the same monetary reinforcements as participants in the experimental treatment groups. They also completed 3 hours of "training" per week over 12 weeks, for a total of 36 hours.
Overall Study
Lost to Follow-up
10
5
1

Baseline Characteristics

Evaluating Two Types of Cognitive Training in Veterans With Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Specific Perceptual Training - Brain Fitness Program (BFP)
n=39 Participants
In each session, participants worked 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. Brain Fitness Program (BFP): 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.
Broad Cognitive Training - Cognitive Package (Cogpack)
n=40 Participants
In each session, participants worked 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. Cognitive Package (Cogpack): 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, psychomotor speed) that were not included in this protocol to better separate bottom-up from top-down training interventions. There was a total of 34 exercises and variants of the same exercises with different levels of difficulty.
Control Treatment - Commercial Computer Games (Sporcle)
n=20 Participants
In each session, participants played 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. Commercial Computer Games (Sporcle): Sporcle computer games were 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 received the same amount of attention from staff members and the same monetary reinforcements as participants in the experimental treatment groups. They also completed 3 hours of "training" per week over 12 weeks, for a total of 36 hours.
Total
n=99 Participants
Total of all reporting groups
Age, Continuous
51.59 years
STANDARD_DEVIATION 9.44 • n=93 Participants
51.05 years
STANDARD_DEVIATION 9.42 • n=4 Participants
51.0 years
STANDARD_DEVIATION 9.54 • n=27 Participants
51.18 years
STANDARD_DEVIATION 9.29 • n=483 Participants
Sex: Female, Male
Female
7 Participants
n=93 Participants
9 Participants
n=4 Participants
6 Participants
n=27 Participants
22 Participants
n=483 Participants
Sex: Female, Male
Male
32 Participants
n=93 Participants
31 Participants
n=4 Participants
14 Participants
n=27 Participants
77 Participants
n=483 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
n=93 Participants
4 Participants
n=4 Participants
4 Participants
n=27 Participants
14 Participants
n=483 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
33 Participants
n=93 Participants
35 Participants
n=4 Participants
16 Participants
n=27 Participants
84 Participants
n=483 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
1 Participants
n=4 Participants
0 Participants
n=27 Participants
1 Participants
n=483 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
Race (NIH/OMB)
Asian
2 Participants
n=93 Participants
2 Participants
n=4 Participants
0 Participants
n=27 Participants
4 Participants
n=483 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
Race (NIH/OMB)
Black or African American
21 Participants
n=93 Participants
14 Participants
n=4 Participants
11 Participants
n=27 Participants
46 Participants
n=483 Participants
Race (NIH/OMB)
White
13 Participants
n=93 Participants
23 Participants
n=4 Participants
9 Participants
n=27 Participants
45 Participants
n=483 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
2 Participants
n=483 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=93 Participants
1 Participants
n=4 Participants
0 Participants
n=27 Participants
2 Participants
n=483 Participants
Region of Enrollment
United States
39 Participants
n=93 Participants
40 Participants
n=4 Participants
20 Participants
n=27 Participants
99 Participants
n=483 Participants
MCCB neurocognition composite
42.52 units on a scale
STANDARD_DEVIATION 8.75 • n=93 Participants
41.57 units on a scale
STANDARD_DEVIATION 8.41 • n=4 Participants
41.18 units on a scale
STANDARD_DEVIATION 8.70 • n=27 Participants
41.76 units on a scale
STANDARD_DEVIATION 8.62 • n=483 Participants
UPSA total
74.85 units on a scale
STANDARD_DEVIATION 10.73 • n=93 Participants
74.27 units on a scale
STANDARD_DEVIATION 11.72 • n=4 Participants
77.25 units on a scale
STANDARD_DEVIATION 13.99 • n=27 Participants
75.46 units on a scale
STANDARD_DEVIATION 12.15 • n=483 Participants
MMN amplitude
-2.21 units on a scale
STANDARD_DEVIATION 2.12 • n=93 Participants
-2.25 units on a scale
STANDARD_DEVIATION 1.69 • n=4 Participants
-2.18 units on a scale
STANDARD_DEVIATION 2.18 • n=27 Participants
-2.21 units on a scale
STANDARD_DEVIATION 2.0 • n=483 Participants

PRIMARY outcome

Timeframe: Within one week of training completion

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.

Outcome measures

Outcome measures
Measure
Specific Auditory Training - Brain Fitness Program (BFP)
n=29 Participants
In each session, participants worked 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. Brain Fitness Program (BFP): 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.
Broad Cognitive Training - Cognitive Package (Cogpack)
n=35 Participants
In each session, participants worked 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. Cognitive Package (Cogpack): 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, psychomotor speed) that were not included in this protocol to better separate bottom-up from top-down training interventions. There was a total of 34 exercises and variants of the same exercises with different levels of difficulty.
Control Treatment - Commercial Computer Games (Sporcle)
n=19 Participants
In each session, participants played 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. Commercial Computer Games (Sporcle): Sporcle computer games were 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 received the same amount of attention from staff members and the same monetary reinforcements as participants in the experimental treatment groups. They also completed 3 hours of "training" per week over 12 weeks, for a total of 36 hours.
Neurocognition
42.02 score on a scale
Standard Deviation 7.96
41.92 score on a scale
Standard Deviation 8.47
41.94 score on a scale
Standard Deviation 8.72

SECONDARY outcome

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

A Mismatch Negativity (MMN) Paradigm was used to assess basic auditory processing. MMN amplitude was measured as the mean voltage in the 145-200 ms latency range at pooled frontocentral electodes. Minimum and maximum values are -8 and +2 microvolts. More negative scores mean a better outcome.

Outcome measures

Outcome measures
Measure
Specific Auditory Training - Brain Fitness Program (BFP)
n=29 Participants
In each session, participants worked 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. Brain Fitness Program (BFP): 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.
Broad Cognitive Training - Cognitive Package (Cogpack)
n=35 Participants
In each session, participants worked 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. Cognitive Package (Cogpack): 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, psychomotor speed) that were not included in this protocol to better separate bottom-up from top-down training interventions. There was a total of 34 exercises and variants of the same exercises with different levels of difficulty.
Control Treatment - Commercial Computer Games (Sporcle)
n=19 Participants
In each session, participants played 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. Commercial Computer Games (Sporcle): Sporcle computer games were 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 received the same amount of attention from staff members and the same monetary reinforcements as participants in the experimental treatment groups. They also completed 3 hours of "training" per week over 12 weeks, for a total of 36 hours.
Electroencephalography (EEG)
MMN at 12 weeks
-2.04 units on a scale
Standard Deviation 1.77
-2.17 units on a scale
Standard Deviation 1.86
-2.09 units on a scale
Standard Deviation 1.87
Electroencephalography (EEG)
MMN at 6 weeks
-1.78 units on a scale
Standard Deviation 1.76
-2.16 units on a scale
Standard Deviation 1.83
-2.21 units on a scale
Standard Deviation 1.90

SECONDARY outcome

Timeframe: Within one week of training completion

The University of California San Diego (UCSD) Performance-based Skills Assessment (UPSA) was used to assess functional capacity. The UPSA total score served as a secondary functional outcome measure. Minimum and maximum values are 40 and 100. Higher scores mean a better outcome.

Outcome measures

Outcome measures
Measure
Specific Auditory Training - Brain Fitness Program (BFP)
n=29 Participants
In each session, participants worked 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. Brain Fitness Program (BFP): 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.
Broad Cognitive Training - Cognitive Package (Cogpack)
n=35 Participants
In each session, participants worked 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. Cognitive Package (Cogpack): 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, psychomotor speed) that were not included in this protocol to better separate bottom-up from top-down training interventions. There was a total of 34 exercises and variants of the same exercises with different levels of difficulty.
Control Treatment - Commercial Computer Games (Sporcle)
n=19 Participants
In each session, participants played 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. Commercial Computer Games (Sporcle): Sporcle computer games were 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 received the same amount of attention from staff members and the same monetary reinforcements as participants in the experimental treatment groups. They also completed 3 hours of "training" per week over 12 weeks, for a total of 36 hours.
Functional Capacity
76.50 score on a scale
Standard Deviation 10.59
75.96 score on a scale
Standard Deviation 11.25
76.77 score on a scale
Standard Deviation 11.51

Adverse Events

Specific Perceptual Training - Brain Fitness Program (BFP)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Broad Cognitive Training - Cognitive Package (Cogpack)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Control Treatment - Commercial Computer Games (Sporcle)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Specific Perceptual Training - Brain Fitness Program (BFP)
n=39 participants at risk
In each session, participants worked 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. Brain Fitness Program (BFP): 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.
Broad Cognitive Training - Cognitive Package (Cogpack)
n=40 participants at risk
In each session, participants worked 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. Cognitive Package (Cogpack): 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, psychomotor speed) that were not included in this protocol to better separate bottom-up from top-down training interventions. There was a total of 34 exercises and variants of the same exercises with different levels of difficulty.
Control Treatment - Commercial Computer Games (Sporcle)
n=20 participants at risk
In each session, participants played 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. Commercial Computer Games (Sporcle): Sporcle computer games were 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 received the same amount of attention from staff members and the same monetary reinforcements as participants in the experimental treatment groups. They also completed 3 hours of "training" per week over 12 weeks, for a total of 36 hours.
Psychiatric disorders
Other
5.1%
2/39 • Number of events 2 • 12 weeks
5.0%
2/40 • Number of events 2 • 12 weeks
5.0%
1/20 • Number of events 1 • 12 weeks

Additional Information

Dr. Carol Jahchan

VA Greater Los Angeles Healthcare System

Phone: 310-478-3711

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place