Trial Outcomes & Findings for Brain Markers of Improvements in Cognitive Functioning (NCT NCT03490110)

Results Overview

The investigators created a composite score based upon standardized performance on the following neurocognitive measures of attention and executive functions: Wechsler Adult Intelligence Test - 4th Edition- letter number sequence; Auditory Consonant Trigrams - 9, 18, 36 second conditions; Digit Vigilance Test - Total Errors; Delis-Kaplan Executive Function System Color-Word Interference Trials 3 and 4 - Time and Total Errors; \& Trails B - Time. Performance on each measure was scored using populations norms, and these scores are then standardized (Z-scored) and averaged to create a composite outcome (the unit measure being Z-score). A Z-score reflects the number of standard deviations a given score is away from the population mean: A Z-score of 0 is equal to the population mean, with positive and negative values reflecting performances above and below the population mean, respectively.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

Week 1, before intervention period (baseline)

Results posted on

2020-03-23

Participant Flow

Participant milestones

Participant milestones
Measure	State Regulation Skill Training This arm utilizes a training system designed to strengthen goal-directed cognitive-emotional state regulation skills. The emphasis is on practice and active application of skills across a range of challenge contexts. Digital scenarios provide experiential learning opportunities, allowing Veterans to apply skills to tackle challenges that are calibrated to maximize learning. Coaches guide learning for successful application of skills to challenges in personal life. State regulation skill training: Participants complete seven supervised training sessions. Training sessions last 2 hours, and participants are requested to complete approximately 2.5 hours of additional skill practice over the course of each week outside of session (total \~4.5 hours per week).	Treatment-as-usual In this arm, participants receive clinical care as usual in VA and other clinics. Treatment-as-usual: Participants receive clinical care as usual over a matched time period.
Overall Study STARTED	9	9
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brain Markers of Improvements in Cognitive Functioning

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	State Regulation Skill Training n=9 Participants This arm utilizes a training system designed to strengthen goal-directed cognitive-emotional state regulation skills. The emphasis is on practice and active application of skills across a range of challenge contexts. Digital scenarios provide experiential learning opportunities, allowing Veterans to apply skills to tackle challenges that are calibrated to maximize learning. Coaches guide learning for successful application of skills to challenges in personal life. State regulation skill training: Participants complete seven supervised training sessions. Training sessions last 2 hours, and participants are requested to complete approximately 2.5 hours of additional skill practice over the course of each week outside of session (total \~4.5 hours per week).	Treatment-as-usual n=9 Participants In this arm, participants receive clinical care as usual in VA and other clinics. Treatment-as-usual: Participants receive clinical care as usual over a matched time period.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	40.4 years STANDARD_DEVIATION 9.00 • n=5 Participants	38.00 years STANDARD_DEVIATION 9.61 • n=7 Participants	39.29 years STANDARD_DEVIATION 9.08 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 1, before intervention period (baseline)

The investigators created a composite score based upon standardized performance on the following neurocognitive measures of attention and executive functions: Wechsler Adult Intelligence Test - 4th Edition- letter number sequence; Auditory Consonant Trigrams - 9, 18, 36 second conditions; Digit Vigilance Test - Total Errors; Delis-Kaplan Executive Function System Color-Word Interference Trials 3 and 4 - Time and Total Errors; \& Trails B - Time. Performance on each measure was scored using populations norms, and these scores are then standardized (Z-scored) and averaged to create a composite outcome (the unit measure being Z-score). A Z-score reflects the number of standard deviations a given score is away from the population mean: A Z-score of 0 is equal to the population mean, with positive and negative values reflecting performances above and below the population mean, respectively.

Outcome measures

Outcome measures
Measure	State Regulation Skill Training n=6 Participants This arm utilizes a training system designed to strengthen goal-directed cognitive-emotional state regulation skills. The emphasis is on practice and active application of skills across a range of challenge contexts. Digital scenarios provide experiential learning opportunities, allowing Veterans to apply skills to tackle challenges that are calibrated to maximize learning. Coaches guide learning for successful application of skills to challenges in personal life. State regulation skill training: Participants complete seven supervised training sessions. Training sessions last 2 hours, and participants are requested to complete approximately 2.5 hours of additional skill practice over the course of each week outside of session (total \~4.5 hours per week).	Treatment-as-usual n=6 Participants In this arm, participants receive clinical care as usual in VA and other clinics. Treatment-as-usual: Participants receive clinical care as usual over a matched time period.
Composite Score of Attention and Executive Functioning From a Neurocognitive Test Battery	0.18 units on a scale Standard Deviation 0.79	-0.06 units on a scale Standard Deviation 0.72

PRIMARY outcome

Timeframe: Week 8, after the intervention period

The investigators created a composite score based upon standardized performance on the following neurocognitive measures of attention and executive functions: Wechsler Adult Intelligence Test - 4th Edition- letter number sequence; Auditory Consonant Trigrams - 9, 18, 36 second conditions; Digit Vigilance Test - Total Errors; Delis-Kaplan Executive Function System Color-Word Interference Trials 3 and 4 - Time and Total Errors; \& Trails B - Time. Performance on each measure was scored using populations norms, and these scores are then standardized (Z-scored) and averaged to create a composite outcome (the unit measure being Z-score). A Z-score reflects the number of standard deviations a given score is away from the population mean: A Z-score of 0 is equal to the population mean, with positive and negative values reflecting performances above and below the population mean, respectively. Change will be analyzed for this data as change from before to after the intervention period.

Outcome measures

Outcome measures
Measure	State Regulation Skill Training n=6 Participants This arm utilizes a training system designed to strengthen goal-directed cognitive-emotional state regulation skills. The emphasis is on practice and active application of skills across a range of challenge contexts. Digital scenarios provide experiential learning opportunities, allowing Veterans to apply skills to tackle challenges that are calibrated to maximize learning. Coaches guide learning for successful application of skills to challenges in personal life. State regulation skill training: Participants complete seven supervised training sessions. Training sessions last 2 hours, and participants are requested to complete approximately 2.5 hours of additional skill practice over the course of each week outside of session (total \~4.5 hours per week).	Treatment-as-usual n=6 Participants In this arm, participants receive clinical care as usual in VA and other clinics. Treatment-as-usual: Participants receive clinical care as usual over a matched time period.
Composite Score of Attention and Executive Functioning From a Neurocognitive Test Battery	0.49 units on a scale Standard Deviation 0.75	-0.13 units on a scale Standard Deviation 0.45

SECONDARY outcome

Timeframe: Week 8, after the intervention period

Electroencephalography (EEG) will be collected during tasks that require attention and working memory. The old/new ERP effect (difference between brain responses to correctly remembered studied items vs. correctly rejected unstudied items) will be analyzed for this data as change from before to after the intervention period.

Outcome measures

Outcome measures
Measure	State Regulation Skill Training n=6 Participants This arm utilizes a training system designed to strengthen goal-directed cognitive-emotional state regulation skills. The emphasis is on practice and active application of skills across a range of challenge contexts. Digital scenarios provide experiential learning opportunities, allowing Veterans to apply skills to tackle challenges that are calibrated to maximize learning. Coaches guide learning for successful application of skills to challenges in personal life. State regulation skill training: Participants complete seven supervised training sessions. Training sessions last 2 hours, and participants are requested to complete approximately 2.5 hours of additional skill practice over the course of each week outside of session (total \~4.5 hours per week).	Treatment-as-usual n=6 Participants In this arm, participants receive clinical care as usual in VA and other clinics. Treatment-as-usual: Participants receive clinical care as usual over a matched time period.
Change in Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV) EEG Electrode - Pz	1.55 uV Standard Deviation 1.88	-0.42 uV Standard Deviation 1.58
Change in Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV) EEG Electrode - CPz	2.27 uV Standard Deviation 2.61	0.32 uV Standard Deviation 1.17

SECONDARY outcome

Timeframe: Week 1, before the intervention period

Electroencephalography (EEG) will be collected during tasks that require attention and working memory. The old/new ERP effect (difference between brain responses to correctly remembered studied items vs. correctly rejected unstudied items) will be analyzed for this data prior to the intervention period.

Outcome measures

Outcome measures
Measure	State Regulation Skill Training n=6 Participants This arm utilizes a training system designed to strengthen goal-directed cognitive-emotional state regulation skills. The emphasis is on practice and active application of skills across a range of challenge contexts. Digital scenarios provide experiential learning opportunities, allowing Veterans to apply skills to tackle challenges that are calibrated to maximize learning. Coaches guide learning for successful application of skills to challenges in personal life. State regulation skill training: Participants complete seven supervised training sessions. Training sessions last 2 hours, and participants are requested to complete approximately 2.5 hours of additional skill practice over the course of each week outside of session (total \~4.5 hours per week).	Treatment-as-usual n=6 Participants In this arm, participants receive clinical care as usual in VA and other clinics. Treatment-as-usual: Participants receive clinical care as usual over a matched time period.
Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV) EEG Electrode - Pz	0.56 uV Standard Deviation 1.06	-0.07 uV Standard Deviation 1.37
Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV) EEG Electrode - CPz	1.41 uV Standard Deviation 2.30	0.60 uV Standard Deviation 0.99

SECONDARY outcome

Timeframe: Week 8, after the intervention period

EEG will be collected during a focused rest condition. Network modularity will be estimated from a matrix of connections between electrodes based on phase coherence, a unit-less measure of correlation between phase angles of EEG signals in the theta (4-8 Hz) frequency range. The modularity metric reflects the strength of modular network organization by summing the difference between the fraction of within-module connections to the total fraction of connections across modules, thus ranging from 0 (random) to 1 (completely modular). Change in network modularity will be analyzed for this data as change from before to after the intervention period.

Outcome measures

Outcome measures
Measure	State Regulation Skill Training n=6 Participants This arm utilizes a training system designed to strengthen goal-directed cognitive-emotional state regulation skills. The emphasis is on practice and active application of skills across a range of challenge contexts. Digital scenarios provide experiential learning opportunities, allowing Veterans to apply skills to tackle challenges that are calibrated to maximize learning. Coaches guide learning for successful application of skills to challenges in personal life. State regulation skill training: Participants complete seven supervised training sessions. Training sessions last 2 hours, and participants are requested to complete approximately 2.5 hours of additional skill practice over the course of each week outside of session (total \~4.5 hours per week).	Treatment-as-usual n=6 Participants In this arm, participants receive clinical care as usual in VA and other clinics. Treatment-as-usual: Participants receive clinical care as usual over a matched time period.
Network Modularity From EEG	0.001 units on a scale Standard Deviation 0.018	-0.002 units on a scale Standard Deviation 0.013

Adverse Events

State Regulation Skill Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment-as-usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Anthony Chen

Veterans Affairs

Phone: 925-372-2530

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place