Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I01RX000180 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TDCS | Experimental | TDCS offered concurrent with working memory focused cognitive training |
|
| Sham | Sham Comparator | Sham stimulation offered concurrent with working memory focused cognitive training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TDCS | Device | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Total score at Baseline, 4 months, and 5.5 months |
| 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. | D Prime at Baseline, 4 months, and 5.5 months |
| 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. | Z-score at Baseline, 4 months, and 5.5 months |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
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
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tasha M Nienow, PhD | Minneapolis VA Health Care System, Minneapolis, MN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota | 55417 | United States |
A de-identified, anonymized dataset will be created and shared. Final data set will be made available upon written request. In order to fulfill requests, I will ensure that all data storage locations are kept current in the Minneapolis VAHCS Data Inventory database, and I will store all study research records and data for a minimum of 6 fiscal years post study closure.
Data will be available at study closure and accessible for 6 years.
When a request for data is received, an agreement will be set up and approved by the local facility before data is released.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Assessment |
|
| ||||||||||||||||||
| 2nd Baseline Assessment |
| |||||||||||||||||||
| Intervention |
| |||||||||||||||||||
| 4-month Assessment |
| |||||||||||||||||||
| 5.5 Month Assessment |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Participants who completed the intervention. | Posted | Mean | Standard Deviation | Proportion of correct responses | Total score at Baseline, 4 months, and 5.5 months |
|
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.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Metabolism and nutrition disorders | Non-systematic Assessment | Participant was hospitalized for treatment and stabilization of a pre-existing medical condition while enrolled in the study. |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tasha Nienow | Minneapolis VA Health Care System | 612-467-1004 | tasha.nienow@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 19, 2022 | Sep 20, 2022 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D000072466 | Cognitive Remediation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
Not provided
Not provided
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.
Not provided
Not provided
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.
|
| Sham Stimulation | Device | 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 | Behavioral | 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 | Behavioral | 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 score at Baseline, 4 months, and 5.5 months |
| Total score at Baseline, 4 months, and 5.5 months |
| 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. | D prime at Baseline, 4 months, and 5.5 months |
| 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. | Z-score at Baseline, 4 months, and 5.5 months |
| 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. | T-score at Baseline, 4 months, and 5.5 months |
| 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. | Total score at Baseline, 4 months, and 5.5 months |
| 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 | Total score at Baseline, 4 months, and 5.5 months |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Years of Education | Mean | Standard Deviation | years |
|
| Test of Premorbid Functioning Standard Score | This is a measure of intellectual function prior to the onset of illness or disease. Scores range from 50 to 135. Higher scores indicate better intellectual functioning. A score of 100 is considered average. | Mean | Standard Deviation | units on a scale |
|
| N-Back D-Prime Score | This is a working memory task. A 2-back version was administered. D prime a measure of response accuracy that takes into account both hit rate and false alarm rate was used to measure performance. Scores range from -4.54 to 4.54, with higher, positive scores indicating better working memory performance. A score of 0 indicates chance level performance. | 5 participants withdrew from the baseline assessment process before data on this measure could be collected from them. | Mean | Standard Deviation | D prime |
|
| OG001 | 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. |
|
|
|
| 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. | Participants who completed the intervention. | Posted | Mean | Standard Deviation | D Prime | D Prime at Baseline, 4 months, and 5.5 months |
|
|
|
|
| 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. | Participants who completed the intervention. | Posted | Mean | Standard Deviation | Z-score | Z-score at Baseline, 4 months, and 5.5 months |
|
|
|
|
| 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. | Participants who completed the intervention. | Posted | Mean | Standard Deviation | score on a scale | Total score at Baseline, 4 months, and 5.5 months |
|
|
|
|
| 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. | Participants who completed the intervention. | Posted | Mean | Standard Deviation | score on a scale | Total score at Baseline, 4 months, and 5.5 months |
|
|
|
|
| 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. | Participants who completed the intervention. | Posted | Mean | Standard Deviation | D prime | D prime at Baseline, 4 months, and 5.5 months |
|
|
|
|
| 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. | Participants who completed the intervention. | Posted | Mean | Standard Deviation | Z-score | Z-score at Baseline, 4 months, and 5.5 months |
|
|
|
|
| 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. | Participants who completed the intervention. | Posted | Mean | Standard Deviation | T-score | T-score at Baseline, 4 months, and 5.5 months |
|
|
|
|
| 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. | Participants who completed the intervention. | Posted | Mean | Standard Deviation | score on a scale | Total score at Baseline, 4 months, and 5.5 months |
|
|
|
|
| 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 | Participants who completed the intervention. | Posted | Mean | Standard Deviation | score on a scale | Total score at Baseline, 4 months, and 5.5 months |
|
|
|
|
| 0 |
| 9 |
| 1 |
| 9 |
| 0 |
| 9 |
| EG001 | 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. | 0 | 8 | 0 | 8 | 0 | 8 |
|
Not provided
Not provided
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 5.5 months |
|
| Mixed Models Analysis |
| = .24 |
| Superiority |
| 5.5-month assessment |
|
| Mixed Models Analysis |
| = .09 |
| Superiority |
| Within group change assessed between baseline and 4-month assessment. | t-test, 2 sided | = .02 | Superiority |
| Within group change assessed between baseline and the 5.5 month assessment. | t-test, 2 sided | = .48 | Superiority |
| Within group change assessed between baseline and 4-month assessment. | t-test, 2 sided | = .66 | Superiority |
| Within group change assessed between baseline and 5.5 month assessment. | t-test, 2 sided | = .46 | Superiority |
| 5.5 month assessment |
|
| Mixed Models Analysis |
| = .45 |
| Superiority |
| 5.5 month assessment |
|
| Mixed Models Analysis |
| = .31 |
| Superiority |
| 5.5 month assessment |
|
| Mixed Models Analysis |
| = .50 |
| Superiority |
| 5.5 month assessment |
|
| Mixed Models Analysis |
| = .09 |
| Superiority |
| Within group change assessed between baseline and 4-month assessment. | t-test, 2 sided | = .02 | Superiority |
| Within group change assessed between baseline and the 5.5 month assessment. | t-test, 2 sided | = .48 | Superiority |
| Within group change assessed between baseline and 4-month assessment. | t-test, 2 sided | = .66 | Superiority |
| Within group change assessed between baseline and the 5.5 month assessment. | t-test, 2 sided | = .46 | Superiority |
| 5.5 month assessment |
|
| Mixed Models Analysis |
| = .84 |
| Superiority |
| 5.5 month assessment |
|
| Mixed Models Analysis |
| = .08 |
| Superiority |
| Within group change assessed between baseline and 4-month assessment. | t-test, 2 sided | = .14 | Superiority |
| Within group change assessed between baseline and 5.5-month assessment. | t-test, 2 sided | = .02 | Superiority |
| Within group change assessed between baseline and 4-month assessment. | t-test, 2 sided | = .24 | Superiority |
| Within group change assessed between baseline and 5.5-month assessment. | t-test, 2 sided | = .93 | Superiority |
| 5.5 month assessment |
|
| Mixed Models Analysis |
| = .08 |
| Superiority |
| Within group change assessed between baseline and 4-month assessment. | t-test, 2 sided | = .08 | Superiority |
| Within group change assessed between baseline and 5.5-month assessment. | t-test, 2 sided | = .06 | Superiority |
| Within group change assessed between baseline and 4-month assessment. | t-test, 2 sided | = .28 | Superiority |
| Within group change assessed between baseline and 5.5-month assessment. | t-test, 2 sided | = .23 | Superiority |