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.
COMPLETED
NA
105 participants
Within one week of training completion
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
| 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
| 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
| 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 completionThe 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
| 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 completionA 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
| 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 completionThe 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
| 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)
Broad Cognitive Training - Cognitive Package (Cogpack)
Control Treatment - Commercial Computer Games (Sporcle)
Serious adverse events
Adverse event data not reported
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place