Trial Outcomes & Findings for Restoration of Cognitive Function With TDCS and Training in Serious Mental Illness (NCT NCT03208036)
NCT ID: NCT03208036
Last Updated: 2022-12-21
Results Overview
This is a measure of one core component of working memory. Performance on the Dot Pattern Expectancy Task and AX-Continuous Performance Task was measured with d prime. D Prime is a measure of response accuracy that takes into account both hit rate and false alarm rate. This measure of response accuracy ranges from -4.546 to 4.546, with a higher score indicating better performance. A score of 0 indicates chance level performance. D prime scores reflecting overall performance on the Dot Pattern Expectancy Task and the AX-Continuous Performance Task were averaged. The resulting d prime score reflects performance on the goal maintenance component of working memory.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
D Prime at Baseline, 4 months, and 5.5 months
Results posted on
2022-12-21
Participant Flow
Participant milestones
| Measure |
TDCS
TDCS offered concurrent with working memory focused cognitive training
TDCS: 1 mA of anodal stimulation will be applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training for 20 minutes
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
Sham
Sham stimulation offered concurrent with working memory focused cognitive training
Sham Stimulation: Participants will receive 20 seconds of 1 mA anodal stimulation applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training to mimic the effect of the active condition
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
|---|---|---|
|
Baseline Assessment
STARTED
|
11
|
11
|
|
Baseline Assessment
COMPLETED
|
10
|
10
|
|
Baseline Assessment
NOT COMPLETED
|
1
|
1
|
|
2nd Baseline Assessment
STARTED
|
10
|
10
|
|
2nd Baseline Assessment
COMPLETED
|
9
|
8
|
|
2nd Baseline Assessment
NOT COMPLETED
|
1
|
2
|
|
Intervention
STARTED
|
9
|
8
|
|
Intervention
COMPLETED
|
6
|
6
|
|
Intervention
NOT COMPLETED
|
3
|
2
|
|
4-month Assessment
STARTED
|
6
|
6
|
|
4-month Assessment
COMPLETED
|
6
|
6
|
|
4-month Assessment
NOT COMPLETED
|
0
|
0
|
|
5.5 Month Assessment
STARTED
|
6
|
6
|
|
5.5 Month Assessment
COMPLETED
|
5
|
4
|
|
5.5 Month Assessment
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
TDCS
TDCS offered concurrent with working memory focused cognitive training
TDCS: 1 mA of anodal stimulation will be applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training for 20 minutes
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
Sham
Sham stimulation offered concurrent with working memory focused cognitive training
Sham Stimulation: Participants will receive 20 seconds of 1 mA anodal stimulation applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training to mimic the effect of the active condition
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
|---|---|---|
|
Baseline Assessment
Withdrawal by Subject
|
1
|
1
|
|
2nd Baseline Assessment
Withdrawal by Subject
|
1
|
2
|
|
Intervention
Withdrawal by Subject
|
3
|
2
|
|
5.5 Month Assessment
Partial data collected due to COVID-19 pandemic and remote procedures only
|
1
|
2
|
Baseline Characteristics
5 participants withdrew from the baseline assessment process before data on this measure could be collected from them.
Baseline characteristics by cohort
| Measure |
TDCS
n=11 Participants
TDCS offered concurrent with working memory focused cognitive training
TDCS: 1 mA of anodal stimulation will be applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training for 20 minutes
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
Sham
n=11 Participants
Sham stimulation offered concurrent with working memory focused cognitive training
Sham Stimulation: Participants will receive 20 seconds of 1 mA anodal stimulation applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training to mimic the effect of the active condition
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=11 Participants
|
11 Participants
n=11 Participants
|
22 Participants
n=22 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Age, Continuous
|
51.55 years
STANDARD_DEVIATION 8.29 • n=11 Participants
|
51.27 years
STANDARD_DEVIATION 7.94 • n=11 Participants
|
51.41 years
STANDARD_DEVIATION 8.12 • n=22 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
3 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=11 Participants
|
11 Participants
n=11 Participants
|
19 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=11 Participants
|
11 Participants
n=11 Participants
|
22 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=11 Participants
|
3 Participants
n=11 Participants
|
5 Participants
n=22 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=11 Participants
|
7 Participants
n=11 Participants
|
15 Participants
n=22 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
1 Participants
n=11 Participants
|
1 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=11 Participants
|
11 Participants
n=11 Participants
|
22 Participants
n=22 Participants
|
|
Years of Education
|
13.27 years
STANDARD_DEVIATION 1.42 • n=11 Participants
|
13.46 years
STANDARD_DEVIATION 1.04 • n=11 Participants
|
13.37 years
STANDARD_DEVIATION 1.23 • n=22 Participants
|
|
Test of Premorbid Functioning Standard Score
|
94.09 units on a scale
STANDARD_DEVIATION 12.23 • n=11 Participants
|
96.79 units on a scale
STANDARD_DEVIATION 8.30 • n=11 Participants
|
95.44 units on a scale
STANDARD_DEVIATION 10.27 • n=22 Participants
|
|
N-Back D-Prime Score
|
1.07 D prime
STANDARD_DEVIATION .74 • n=9 Participants • 5 participants withdrew from the baseline assessment process before data on this measure could be collected from them.
|
1.15 D prime
STANDARD_DEVIATION .47 • n=8 Participants • 5 participants withdrew from the baseline assessment process before data on this measure could be collected from them.
|
1.11 D prime
STANDARD_DEVIATION .61 • n=17 Participants • 5 participants withdrew from the baseline assessment process before data on this measure could be collected from them.
|
PRIMARY outcome
Timeframe: Total score at Baseline, 4 months, and 5.5 monthsPopulation: Participants who completed the intervention.
This is a measure of one core component of working memory. Proportion correct average from Change Detection and Change Localization Tasks. Score ranges from 0.00 to 1.00, with a higher score indicating better performance
Outcome measures
| Measure |
TDCS
n=6 Participants
TDCS offered concurrent with working memory focused cognitive training
TDCS: 1 mA of anodal stimulation will be applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training for 20 minutes
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
Sham
n=6 Participants
Sham stimulation offered concurrent with working memory focused cognitive training
Sham Stimulation: Participants will receive 20 seconds of 1 mA anodal stimulation applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training to mimic the effect of the active condition
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
|---|---|---|
|
Working Memory Capacity Composite Score
5.5 month assessment
|
.63 Proportion of correct responses
Standard Deviation .08
|
.71 Proportion of correct responses
Standard Deviation .05
|
|
Working Memory Capacity Composite Score
Baseline
|
.64 Proportion of correct responses
Standard Deviation .13
|
.70 Proportion of correct responses
Standard Deviation .07
|
|
Working Memory Capacity Composite Score
4-month assessment
|
.64 Proportion of correct responses
Standard Deviation .13
|
.72 Proportion of correct responses
Standard Deviation .05
|
PRIMARY outcome
Timeframe: D Prime at Baseline, 4 months, and 5.5 monthsPopulation: Participants who completed the intervention.
This is a measure of one core component of working memory. Performance on the Dot Pattern Expectancy Task and AX-Continuous Performance Task was measured with d prime. D Prime is a measure of response accuracy that takes into account both hit rate and false alarm rate. This measure of response accuracy ranges from -4.546 to 4.546, with a higher score indicating better performance. A score of 0 indicates chance level performance. D prime scores reflecting overall performance on the Dot Pattern Expectancy Task and the AX-Continuous Performance Task were averaged. The resulting d prime score reflects performance on the goal maintenance component of working memory.
Outcome measures
| Measure |
TDCS
n=6 Participants
TDCS offered concurrent with working memory focused cognitive training
TDCS: 1 mA of anodal stimulation will be applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training for 20 minutes
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
Sham
n=6 Participants
Sham stimulation offered concurrent with working memory focused cognitive training
Sham Stimulation: Participants will receive 20 seconds of 1 mA anodal stimulation applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training to mimic the effect of the active condition
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
|---|---|---|
|
Goal Maintenance Composite Score
Baseline
|
3.34 D Prime
Standard Deviation .58
|
2.91 D Prime
Standard Deviation 1.94
|
|
Goal Maintenance Composite Score
4-months
|
2.78 D Prime
Standard Deviation 1.36
|
2.71 D Prime
Standard Deviation 1.50
|
|
Goal Maintenance Composite Score
5.5 months
|
2.60 D Prime
Standard Deviation .48
|
2.73 D Prime
Standard Deviation 1.38
|
PRIMARY outcome
Timeframe: Z-score at Baseline, 4 months, and 5.5 monthsPopulation: Participants who completed the intervention.
This is a measure of one core component of working memory. Performance on Rotation and Reading Complex Span Tasks was measured with z-scores. Scores range from -3 to 3, with a higher positive score indicating better performance. A score of 0 represents the sample mean at the baseline assessment. The z-scores reflecting overall performance on Rotation and Reading Span Tasks were averaged to create one z-score that reflects performance on the interference control component of working memory.
Outcome measures
| Measure |
TDCS
n=6 Participants
TDCS offered concurrent with working memory focused cognitive training
TDCS: 1 mA of anodal stimulation will be applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training for 20 minutes
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
Sham
n=6 Participants
Sham stimulation offered concurrent with working memory focused cognitive training
Sham Stimulation: Participants will receive 20 seconds of 1 mA anodal stimulation applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training to mimic the effect of the active condition
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
|---|---|---|
|
Interference Control Composite Score
Baseline
|
-.37 Z-score
Standard Deviation .62
|
-.20 Z-score
Standard Deviation .94
|
|
Interference Control Composite Score
4-month assessment
|
-.03 Z-score
Standard Deviation .52
|
-.10 Z-score
Standard Deviation 1.16
|
|
Interference Control Composite Score
5.5-month assessment
|
-.28 Z-score
Standard Deviation .80
|
-.40 Z-score
Standard Deviation .94
|
PRIMARY outcome
Timeframe: Total score at Baseline, 4 months, and 5.5 monthsPopulation: Participants who completed the intervention.
This is a performance-based measure of functional capacity to perform activities of daily living. This measure has two scales, measuring financial and communication skills. The two scales are summed to create a total score. The Total score ranges from 0-100, with a higher score indicating better performance.
Outcome measures
| Measure |
TDCS
n=6 Participants
TDCS offered concurrent with working memory focused cognitive training
TDCS: 1 mA of anodal stimulation will be applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training for 20 minutes
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
Sham
n=6 Participants
Sham stimulation offered concurrent with working memory focused cognitive training
Sham Stimulation: Participants will receive 20 seconds of 1 mA anodal stimulation applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training to mimic the effect of the active condition
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
|---|---|---|
|
The University of California San Diego Performance-Based Skills Assessment Total Score
Baseline
|
78.33 score on a scale
Standard Deviation 9.73
|
73.67 score on a scale
Standard Deviation 14.95
|
|
The University of California San Diego Performance-Based Skills Assessment Total Score
4-month assessment
|
82.00 score on a scale
Standard Deviation 9.55
|
76.50 score on a scale
Standard Deviation 11.42
|
|
The University of California San Diego Performance-Based Skills Assessment Total Score
5.5 month assessment
|
78.36 score on a scale
Standard Deviation 13.67
|
77.76 score on a scale
Standard Deviation 9.34
|
SECONDARY outcome
Timeframe: Total score at Baseline, 4 months, and 5.5 monthsPopulation: Participants who completed the intervention.
Total score summed from Actual Performance subscales 1-5. This is a self-report measure of social and community functioning in the past 3 months. Scores reflect the frequency with which participants report engaging in a behavior. Total score ranges from 20-80, with a higher score indicating better social functioning in the community.
Outcome measures
| Measure |
TDCS
n=6 Participants
TDCS offered concurrent with working memory focused cognitive training
TDCS: 1 mA of anodal stimulation will be applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training for 20 minutes
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
Sham
n=6 Participants
Sham stimulation offered concurrent with working memory focused cognitive training
Sham Stimulation: Participants will receive 20 seconds of 1 mA anodal stimulation applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training to mimic the effect of the active condition
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
|---|---|---|
|
First-Episode Social Functioning Scale Actual Performance Total Score
Baseline
|
55.33 score on a scale
Standard Deviation 5.43
|
55.17 score on a scale
Standard Deviation 8.68
|
|
First-Episode Social Functioning Scale Actual Performance Total Score
4-month assessment
|
56.17 score on a scale
Standard Deviation 5.42
|
56.50 score on a scale
Standard Deviation 8.53
|
|
First-Episode Social Functioning Scale Actual Performance Total Score
5.5 month assessment
|
58.67 score on a scale
Standard Deviation 10.17
|
53.50 score on a scale
Standard Deviation 8.17
|
SECONDARY outcome
Timeframe: D prime at Baseline, 4 months, and 5.5 monthsPopulation: Participants who completed the intervention.
This is a working memory task. The number and picture n-back tasks are novel versions of the training tasks used in this protocol. D-prime, a measure of response accuracy that takes into account hit rate and false alarm rate was used to measure overall performance on each task. This measure of performance accuracy ranges from -4.546 to 4.546, with a higher, positive score indicating better performance. A score of 0 indicates chance level performance. D prime scores from the number and picture task were average to create one d prime measure that reflects performance on novel, untrained n-back measures. Improvement on these tasks would indicate generalization of learning from the trained tasks.
Outcome measures
| Measure |
TDCS
n=6 Participants
TDCS offered concurrent with working memory focused cognitive training
TDCS: 1 mA of anodal stimulation will be applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training for 20 minutes
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
Sham
n=6 Participants
Sham stimulation offered concurrent with working memory focused cognitive training
Sham Stimulation: Participants will receive 20 seconds of 1 mA anodal stimulation applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training to mimic the effect of the active condition
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
|---|---|---|
|
Novel N-Back Task D Prime Score
Baseline
|
1.24 D prime
Standard Deviation .46
|
1.29 D prime
Standard Deviation .46
|
|
Novel N-Back Task D Prime Score
4-month assessment
|
1.41 D prime
Standard Deviation .62
|
1.34 D prime
Standard Deviation .46
|
|
Novel N-Back Task D Prime Score
5.5 month assessment
|
1.42 D prime
Standard Deviation .30
|
1.33 D prime
Standard Deviation .19
|
SECONDARY outcome
Timeframe: Z-score at Baseline, 4 months, and 5.5 monthsPopulation: Participants who completed the intervention.
This is a working memory task. This measure is an indicator of whether participants were able to improve on a task procedurally similar to the training tasks. Rotation and Reading complex span tasks are novel versions of training tasks. A z-score was used to measure performance on each task. Z-scores range from -3 to 3, with a higher positive score indicating better performance. A score of 0 represents the sample mean at the baseline assessment. Z-scores from the Rotation and Reading span tasks were averaged to create one measure of working memory. Improvement on this task would indicate generalization of learning from the training.
Outcome measures
| Measure |
TDCS
n=6 Participants
TDCS offered concurrent with working memory focused cognitive training
TDCS: 1 mA of anodal stimulation will be applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training for 20 minutes
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
Sham
n=6 Participants
Sham stimulation offered concurrent with working memory focused cognitive training
Sham Stimulation: Participants will receive 20 seconds of 1 mA anodal stimulation applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training to mimic the effect of the active condition
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
|---|---|---|
|
Complex Span Task Z-score
Baseline
|
-.37 Z-score
Standard Deviation .62
|
-.20 Z-score
Standard Deviation .94
|
|
Complex Span Task Z-score
4-month assessment
|
-.03 Z-score
Standard Deviation .52
|
-.10 Z-score
Standard Deviation 1.16
|
|
Complex Span Task Z-score
5.5 month assessment
|
-.28 Z-score
Standard Deviation .80
|
-.40 Z-score
Standard Deviation .94
|
SECONDARY outcome
Timeframe: T-score at Baseline, 4 months, and 5.5 monthsPopulation: Participants who completed the intervention.
Two subscales from the MATRICS Consensus Cognitive Battery, the Processing Speed subscale and the Reasoning and Problem-Solving subscale, were averaged to create a composite that reflects performance on cognitive functions closely related to working memory. Performance on each subscale was measured with a T-score. T-scores range from 0-100. A score of 50 reflects the population mean, with a standard deviation of 10. On each subscale, a higher score indicated better performance in the cognitive domain. Improvement on this composite T-score would indicate generalization of training gains to untrained cognitive domains.
Outcome measures
| Measure |
TDCS
n=6 Participants
TDCS offered concurrent with working memory focused cognitive training
TDCS: 1 mA of anodal stimulation will be applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training for 20 minutes
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
Sham
n=6 Participants
Sham stimulation offered concurrent with working memory focused cognitive training
Sham Stimulation: Participants will receive 20 seconds of 1 mA anodal stimulation applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training to mimic the effect of the active condition
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
|---|---|---|
|
MATRICS Consensus Cognitive Battery Processing Speed Subscale and the Reasoning and Problem-Solving Subscale T-score Average
Baseline
|
44.58 T-score
Standard Deviation 10.17
|
49.92 T-score
Standard Deviation 10.47
|
|
MATRICS Consensus Cognitive Battery Processing Speed Subscale and the Reasoning and Problem-Solving Subscale T-score Average
4-month assessment
|
43.50 T-score
Standard Deviation 8.39
|
49.17 T-score
Standard Deviation 9.42
|
|
MATRICS Consensus Cognitive Battery Processing Speed Subscale and the Reasoning and Problem-Solving Subscale T-score Average
5.5 month assessment
|
44.15 T-score
Standard Deviation 10.35
|
50.04 T-score
Standard Deviation 7.92
|
SECONDARY outcome
Timeframe: Total score at Baseline, 4 months, and 5.5 monthsPopulation: Participants who completed the intervention.
This is a 24-item measure of psychiatric symptom severity. Each item is rated on a 1-7 scale, with a higher score indicating that the symptom is more severe. Brief Psychiatric Rating Scale Total score can range from 24-168, with a higher score indicating the presence of more severe psychiatric symptoms.
Outcome measures
| Measure |
TDCS
n=6 Participants
TDCS offered concurrent with working memory focused cognitive training
TDCS: 1 mA of anodal stimulation will be applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training for 20 minutes
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
Sham
n=6 Participants
Sham stimulation offered concurrent with working memory focused cognitive training
Sham Stimulation: Participants will receive 20 seconds of 1 mA anodal stimulation applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training to mimic the effect of the active condition
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
|---|---|---|
|
Brief Psychiatric Rating Scale Total Score
Baseline
|
34.00 score on a scale
Standard Deviation 3.03
|
43.50 score on a scale
Standard Deviation 16.53
|
|
Brief Psychiatric Rating Scale Total Score
4-month assessment
|
32.00 score on a scale
Standard Deviation 3.69
|
38.00 score on a scale
Standard Deviation 9.12
|
|
Brief Psychiatric Rating Scale Total Score
5.5 month assessment
|
31.83 score on a scale
Standard Deviation 3.37
|
43.17 score on a scale
Standard Deviation 11.89
|
SECONDARY outcome
Timeframe: Total score at Baseline, 4 months, and 5.5 monthsPopulation: Participants who completed the intervention.
This is a 13-item scale that measures the severity of negative symptoms. Each item is rated from 0-6, with a higher score indicating that the symptom is more severe. Brief Negative Symptom Severity Scale Total score can range from 0 to 78, with a higher score indicating more severe negative symptoms
Outcome measures
| Measure |
TDCS
n=6 Participants
TDCS offered concurrent with working memory focused cognitive training
TDCS: 1 mA of anodal stimulation will be applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training for 20 minutes
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
Sham
n=6 Participants
Sham stimulation offered concurrent with working memory focused cognitive training
Sham Stimulation: Participants will receive 20 seconds of 1 mA anodal stimulation applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training to mimic the effect of the active condition
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
|---|---|---|
|
Brief Negative Symptom Severity Scale Total Score
4-month assessment
|
13.83 score on a scale
Standard Deviation 6.74
|
21.17 score on a scale
Standard Deviation 8.28
|
|
Brief Negative Symptom Severity Scale Total Score
Baseline
|
18.50 score on a scale
Standard Deviation 7.97
|
25.17 score on a scale
Standard Deviation 14.41
|
|
Brief Negative Symptom Severity Scale Total Score
5.5 month assessment
|
14.40 score on a scale
Standard Deviation 7.61
|
21.00 score on a scale
Standard Deviation 9.12
|
Adverse Events
TDCS
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TDCS
n=9 participants at risk
TDCS offered concurrent with working memory focused cognitive training
TDCS: 1 mA of anodal stimulation will be applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training for 20 minutes
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
Sham
n=8 participants at risk
Sham stimulation offered concurrent with working memory focused cognitive training
Sham Stimulation: Participants will receive 20 seconds of 1 mA anodal stimulation applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training to mimic the effect of the active condition
Cognitive Remediation: Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.
Bridging Group: Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hospitalization
|
11.1%
1/9 • Number of events 1 • Participants were monitored for adverse events between July 2018 and December 2021. Individual participants were enrolled in the study and monitored for adverse events for as long as 10 months.
|
0.00%
0/8 • Participants were monitored for adverse events between July 2018 and December 2021. Individual participants were enrolled in the study and monitored for adverse events for as long as 10 months.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place