Bipolar Disorder, Schizo Affective Disorder, Schizophrenia
Conditions
Keywords
schizophrenia, tdcs, working memory, cognitive remediation, cognition, serious mental illness
Brief summary
Development of interventions that can effectively target and remediate the cognitive and functional impairment associated with serious mental illness is a treatment priority. Transcranial direct current stimulation (tDCS) is a safe, non-invasive neuromodulation technique that is capable of stimulating brain activity to facilitate learning. The primary objective of this study is to evaluate the pairing of two therapeutic techniques, cognitive remediation and tDCS, as a cognitively enhancing intervention. This study is designed to test the hypotheses that cognitive remediation paired with tDCS will be more efficacious than cognitive remediation delivered with sham stimulation and that intervention-induced cognitive change will be sustainable. To examine the incremental benefit of pairing tDCS with cognitive remediation, clinically stable outpatients between the ages of 18-65 who have a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder will be enrolled in a double-blind, double-baseline, sham-controlled clinical trial. Participants will be randomized in a 1:1 ratio to receive either tDCS or sham stimulation concurrent with working memory focused cognitive remediation. Training will be offered to participants in a small group format. Training will consist of 48 sessions, with 2-3 sessions scheduled in a week. Each training session will last 2 hours. One hour will be spent completing cognitive exercises that require working memory skills on a computer. TDCS or sham stimulation will be offered concurrent with the first 20 minutes of training with a StarStim neuromodulator. One mA of anodal stimulation will be applied to the left dorsal lateral prefrontal cortex and the cathodal electrode will be placed in the contralateral supraorbital position. Upon completion of working memory training, participants will transition to a 45-minute bridging group focus on application of cognitive skills in everyday life. To assess intervention-induced change, working memory, other aspects of cognition, functional capacity, community functioning, and symptom severity will be assessed pre- and post-intervention. Sustainability of intervention-induced change will be assessed with an assessment session 6 weeks post-intervention. Mixed effect, repeated measure ANOVAS will be used to analyze intervention-induced change.
Interventions
DEVICETDCS
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
DEVICESham 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
BEHAVIORALCognitive 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.
BEHAVIORALBridging 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Participants, interventionists, and the outcome assessors will be blind to participant condition. The neuromodulation device can be pre-programmed to deliver either tDCS or sham stimulation when an ID code is entered. The study personnel randomizing participants and programming the equipment will not have contact with participants.
Intervention model description
This is a double-blind, double-baseline, sham-controlled study in which participants are randomized to receive either tDCS or sham stimulation concurrent with cognitive training.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants are eligible for the study if they have a diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder and are clinically stable at the time of enrollment * defined as not severely depressed or acutely manic and no hospitalizations or antipsychotic medication changes in the four weeks prior to enrollment
Exclusion criteria
* Met criteria for a severe alcohol or substance use disorder in the last 6 months * Met criteria for a mild alcohol or substance use disorder in the last month * A history of head injury or neurological disease that has compromised cognitive functioning * Ability to speak English is not sufficient to understand study procedures * Diagnosis of learning disability, mental retardation, or pervasive developmental disorder * Diagnosis of a medical condition that is incompatible with tDCS procedures * Participant does not demonstrate understanding of study procedures during the consent process * A documented history of behavioral problems that prevent participation in a group intervention * Participated in a study of tDCS or cognitive remediation in the previous 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Working Memory Capacity Composite Score | Total score at Baseline, 4 months, and 5.5 months | 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 |
| Goal Maintenance Composite Score | D Prime at Baseline, 4 months, and 5.5 months | 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. |
| Interference Control Composite Score | Z-score at Baseline, 4 months, and 5.5 months | 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. |
| The University of California San Diego Performance-Based Skills Assessment Total Score | Total score at Baseline, 4 months, and 5.5 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Psychiatric Rating Scale Total Score | Total score at Baseline, 4 months, and 5.5 months | 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. |
| First-Episode Social Functioning Scale Actual Performance Total Score | Total score at Baseline, 4 months, and 5.5 months | 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. |
| Brief Negative Symptom Severity Scale Total Score | Total score at Baseline, 4 months, and 5.5 months | 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 |
| Novel N-Back Task D Prime Score | D prime at Baseline, 4 months, and 5.5 months | 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. |
| Complex Span Task Z-score | Z-score at Baseline, 4 months, and 5.5 months | 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. |
| MATRICS Consensus Cognitive Battery Processing Speed Subscale and the Reasoning and Problem-Solving Subscale T-score Average | T-score at Baseline, 4 months, and 5.5 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| 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. | 11 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 2nd Baseline Assessment | Withdrawal by Subject | 1 | 2 |
| 5.5 Month Assessment | Partial data collected due to COVID-19 pandemic and remote procedures only | 1 | 2 |
| Baseline Assessment | Withdrawal by Subject | 1 | 1 |
| Intervention | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Sham | TDCS | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 11 Participants | 22 Participants |
| Age, Continuous | 51.27 years STANDARD_DEVIATION 7.94 | 51.55 years STANDARD_DEVIATION 8.29 | 51.41 years STANDARD_DEVIATION 8.12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 11 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| N-Back D-Prime Score | 1.15 D prime STANDARD_DEVIATION 0.47 | 1.07 D prime STANDARD_DEVIATION 0.74 | 1.11 D prime STANDARD_DEVIATION 0.61 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 8 Participants | 15 Participants |
| Region of Enrollment United States | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Female | 0 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 11 Participants | 8 Participants | 19 Participants |
| Test of Premorbid Functioning Standard Score | 96.79 units on a scale STANDARD_DEVIATION 8.3 | 94.09 units on a scale STANDARD_DEVIATION 12.23 | 95.44 units on a scale STANDARD_DEVIATION 10.27 |
| Years of Education | 13.46 years STANDARD_DEVIATION 1.04 | 13.27 years STANDARD_DEVIATION 1.42 | 13.37 years STANDARD_DEVIATION 1.23 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 8 |
| other Total, other adverse events | 0 / 9 | 0 / 8 |
| serious Total, serious adverse events | 1 / 9 | 0 / 8 |
Outcome results
Primary
Goal Maintenance Composite Score
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.
Time frame: D Prime at Baseline, 4 months, and 5.5 months
Population: Participants who completed the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TDCS | Goal Maintenance Composite Score | Baseline | 3.34 D Prime | Standard Deviation 0.58 |
| TDCS | Goal Maintenance Composite Score | 4-months | 2.78 D Prime | Standard Deviation 1.36 |
| TDCS | Goal Maintenance Composite Score | 5.5 months | 2.60 D Prime | Standard Deviation 0.48 |
| Sham | Goal Maintenance Composite Score | Baseline | 2.91 D Prime | Standard Deviation 1.94 |
| Sham | Goal Maintenance Composite Score | 4-months | 2.71 D Prime | Standard Deviation 1.5 |
| Sham | Goal Maintenance Composite Score | 5.5 months | 2.73 D Prime | Standard Deviation 1.38 |
Comparison: Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.p-value: =0.62Mixed Models Analysis
Comparison: Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.p-value: =0.24Mixed Models Analysis
Primary
Interference Control Composite Score
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.
Time frame: Z-score at Baseline, 4 months, and 5.5 months
Population: Participants who completed the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TDCS | Interference Control Composite Score | Baseline | -.37 Z-score | Standard Deviation 0.62 |
| TDCS | Interference Control Composite Score | 4-month assessment | -.03 Z-score | Standard Deviation 0.52 |
| TDCS | Interference Control Composite Score | 5.5-month assessment | -.28 Z-score | Standard Deviation 0.8 |
| Sham | Interference Control Composite Score | Baseline | -.20 Z-score | Standard Deviation 0.94 |
| Sham | Interference Control Composite Score | 4-month assessment | -.10 Z-score | Standard Deviation 1.16 |
| Sham | Interference Control Composite Score | 5.5-month assessment | -.40 Z-score | Standard Deviation 0.94 |
Comparison: Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.p-value: =0.47Mixed Models Analysis
Comparison: Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.p-value: =0.09Mixed Models Analysis
Comparison: Within group change assessed between baseline and 4-month assessment.p-value: =0.02t-test, 2 sided
Comparison: Within group change assessed between baseline and the 5.5 month assessment.p-value: =0.48t-test, 2 sided
Comparison: Within group change assessed between baseline and 4-month assessment.p-value: =0.66t-test, 2 sided
Comparison: Within group change assessed between baseline and 5.5 month assessment.p-value: =0.46t-test, 2 sided
Primary
The University of California San Diego Performance-Based Skills Assessment Total Score
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.
Time frame: Total score at Baseline, 4 months, and 5.5 months
Population: Participants who completed the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TDCS | The University of California San Diego Performance-Based Skills Assessment Total Score | Baseline | 78.33 score on a scale | Standard Deviation 9.73 |
| TDCS | 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 |
| TDCS | 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 |
| Sham | The University of California San Diego Performance-Based Skills Assessment Total Score | Baseline | 73.67 score on a scale | Standard Deviation 14.95 |
| Sham | The University of California San Diego Performance-Based Skills Assessment Total Score | 4-month assessment | 76.50 score on a scale | Standard Deviation 11.42 |
| Sham | The University of California San Diego Performance-Based Skills Assessment Total Score | 5.5 month assessment | 77.76 score on a scale | Standard Deviation 9.34 |
Comparison: Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.p-value: =0.68Mixed Models Analysis
Comparison: Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.p-value: =0.45Mixed Models Analysis
Primary
Working Memory Capacity Composite Score
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
Time frame: Total score at Baseline, 4 months, and 5.5 months
Population: Participants who completed the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TDCS | Working Memory Capacity Composite Score | Baseline | .64 Proportion of correct responses | Standard Deviation 0.13 |
| TDCS | Working Memory Capacity Composite Score | 4-month assessment | .64 Proportion of correct responses | Standard Deviation 0.13 |
| TDCS | Working Memory Capacity Composite Score | 5.5 month assessment | .63 Proportion of correct responses | Standard Deviation 0.08 |
| Sham | Working Memory Capacity Composite Score | Baseline | .70 Proportion of correct responses | Standard Deviation 0.07 |
| Sham | Working Memory Capacity Composite Score | 4-month assessment | .72 Proportion of correct responses | Standard Deviation 0.05 |
| Sham | Working Memory Capacity Composite Score | 5.5 month assessment | .71 Proportion of correct responses | Standard Deviation 0.05 |
Comparison: Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.p-value: =0.69Mixed Models Analysis
Comparison: Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.p-value: =0.74Mixed Models Analysis
Secondary
Brief Negative Symptom Severity Scale Total Score
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
Time frame: Total score at Baseline, 4 months, and 5.5 months
Population: Participants who completed the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TDCS | Brief Negative Symptom Severity Scale Total Score | Baseline | 18.50 score on a scale | Standard Deviation 7.97 |
| TDCS | Brief Negative Symptom Severity Scale Total Score | 4-month assessment | 13.83 score on a scale | Standard Deviation 6.74 |
| TDCS | Brief Negative Symptom Severity Scale Total Score | 5.5 month assessment | 14.40 score on a scale | Standard Deviation 7.61 |
| Sham | Brief Negative Symptom Severity Scale Total Score | Baseline | 25.17 score on a scale | Standard Deviation 14.41 |
| Sham | Brief Negative Symptom Severity Scale Total Score | 4-month assessment | 21.17 score on a scale | Standard Deviation 8.28 |
| Sham | Brief Negative Symptom Severity Scale Total Score | 5.5 month assessment | 21.00 score on a scale | Standard Deviation 9.12 |
Comparison: Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.p-value: =0.98Mixed Models Analysis
Comparison: Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.p-value: =0.08Mixed Models Analysis
Comparison: Within group change assessed between baseline and 4-month assessment.p-value: =0.08t-test, 2 sided
Comparison: Within group change assessed between baseline and 5.5-month assessment.p-value: =0.06t-test, 2 sided
Comparison: Within group change assessed between baseline and 4-month assessment.p-value: =0.28t-test, 2 sided
Comparison: Within group change assessed between baseline and 5.5-month assessment.p-value: =0.23t-test, 2 sided
Secondary
Brief Psychiatric Rating Scale Total Score
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.
Time frame: Total score at Baseline, 4 months, and 5.5 months
Population: Participants who completed the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TDCS | Brief Psychiatric Rating Scale Total Score | Baseline | 34.00 score on a scale | Standard Deviation 3.03 |
| TDCS | Brief Psychiatric Rating Scale Total Score | 4-month assessment | 32.00 score on a scale | Standard Deviation 3.69 |
| TDCS | Brief Psychiatric Rating Scale Total Score | 5.5 month assessment | 31.83 score on a scale | Standard Deviation 3.37 |
| Sham | Brief Psychiatric Rating Scale Total Score | Baseline | 43.50 score on a scale | Standard Deviation 16.53 |
| Sham | Brief Psychiatric Rating Scale Total Score | 4-month assessment | 38.00 score on a scale | Standard Deviation 9.12 |
| Sham | Brief Psychiatric Rating Scale Total Score | 5.5 month assessment | 43.17 score on a scale | Standard Deviation 11.89 |
Comparison: Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.p-value: =0.25Mixed Models Analysis
Comparison: Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.p-value: =0.08Mixed Models Analysis
Comparison: Within group change assessed between baseline and 4-month assessment.p-value: =0.14t-test, 2 sided
Comparison: Within group change assessed between baseline and 5.5-month assessment.p-value: =0.02t-test, 2 sided
Comparison: Within group change assessed between baseline and 4-month assessment.p-value: =0.24t-test, 2 sided
Comparison: Within group change assessed between baseline and 5.5-month assessment.p-value: =0.93t-test, 2 sided
Secondary
Complex Span Task Z-score
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.
Time frame: Z-score at Baseline, 4 months, and 5.5 months
Population: Participants who completed the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TDCS | Complex Span Task Z-score | Baseline | -.37 Z-score | Standard Deviation 0.62 |
| TDCS | Complex Span Task Z-score | 4-month assessment | -.03 Z-score | Standard Deviation 0.52 |
| TDCS | Complex Span Task Z-score | 5.5 month assessment | -.28 Z-score | Standard Deviation 0.8 |
| Sham | Complex Span Task Z-score | Baseline | -.20 Z-score | Standard Deviation 0.94 |
| Sham | Complex Span Task Z-score | 4-month assessment | -.10 Z-score | Standard Deviation 1.16 |
| Sham | Complex Span Task Z-score | 5.5 month assessment | -.40 Z-score | Standard Deviation 0.94 |
Comparison: Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.p-value: =0.47Mixed Models Analysis
Comparison: Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.p-value: =0.09Mixed Models Analysis
Comparison: Within group change assessed between baseline and 4-month assessment.p-value: =0.02t-test, 2 sided
Comparison: Within group change assessed between baseline and the 5.5 month assessment.p-value: =0.48t-test, 2 sided
Comparison: Within group change assessed between baseline and 4-month assessment.p-value: =0.66t-test, 2 sided
Comparison: Within group change assessed between baseline and the 5.5 month assessment.p-value: =0.46t-test, 2 sided
Secondary
First-Episode Social Functioning Scale Actual Performance Total Score
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.
Time frame: Total score at Baseline, 4 months, and 5.5 months
Population: Participants who completed the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TDCS | First-Episode Social Functioning Scale Actual Performance Total Score | Baseline | 55.33 score on a scale | Standard Deviation 5.43 |
| TDCS | First-Episode Social Functioning Scale Actual Performance Total Score | 4-month assessment | 56.17 score on a scale | Standard Deviation 5.42 |
| TDCS | First-Episode Social Functioning Scale Actual Performance Total Score | 5.5 month assessment | 58.67 score on a scale | Standard Deviation 10.17 |
| Sham | First-Episode Social Functioning Scale Actual Performance Total Score | Baseline | 55.17 score on a scale | Standard Deviation 8.68 |
| Sham | First-Episode Social Functioning Scale Actual Performance Total Score | 4-month assessment | 56.50 score on a scale | Standard Deviation 8.53 |
| Sham | First-Episode Social Functioning Scale Actual Performance Total Score | 5.5 month assessment | 53.50 score on a scale | Standard Deviation 8.17 |
Comparison: Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.p-value: =0.81Mixed Models Analysis
Comparison: Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.p-value: =0.31Mixed Models Analysis
Secondary
MATRICS Consensus Cognitive Battery Processing Speed Subscale and the Reasoning and Problem-Solving Subscale T-score Average
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.
Time frame: T-score at Baseline, 4 months, and 5.5 months
Population: Participants who completed the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TDCS | 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 |
| TDCS | 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 |
| TDCS | 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 |
| Sham | MATRICS Consensus Cognitive Battery Processing Speed Subscale and the Reasoning and Problem-Solving Subscale T-score Average | Baseline | 49.92 T-score | Standard Deviation 10.47 |
| Sham | MATRICS Consensus Cognitive Battery Processing Speed Subscale and the Reasoning and Problem-Solving Subscale T-score Average | 4-month assessment | 49.17 T-score | Standard Deviation 9.42 |
| Sham | MATRICS Consensus Cognitive Battery Processing Speed Subscale and the Reasoning and Problem-Solving Subscale T-score Average | 5.5 month assessment | 50.04 T-score | Standard Deviation 7.92 |
Comparison: Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.p-value: =0.99Mixed Models Analysis
Comparison: Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.p-value: =0.84Mixed Models Analysis
Secondary
Novel N-Back Task D Prime Score
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.
Time frame: D prime at Baseline, 4 months, and 5.5 months
Population: Participants who completed the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TDCS | Novel N-Back Task D Prime Score | Baseline | 1.24 D prime | Standard Deviation 0.46 |
| TDCS | Novel N-Back Task D Prime Score | 4-month assessment | 1.41 D prime | Standard Deviation 0.62 |
| TDCS | Novel N-Back Task D Prime Score | 5.5 month assessment | 1.42 D prime | Standard Deviation 0.3 |
| Sham | Novel N-Back Task D Prime Score | Baseline | 1.29 D prime | Standard Deviation 0.46 |
| Sham | Novel N-Back Task D Prime Score | 4-month assessment | 1.34 D prime | Standard Deviation 0.46 |
| Sham | Novel N-Back Task D Prime Score | 5.5 month assessment | 1.33 D prime | Standard Deviation 0.19 |
Comparison: Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.p-value: =0.79Mixed Models Analysis
Comparison: Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.p-value: =0.5Mixed Models Analysis