Trial Outcomes & Findings for Neural Bases of Cognitive Rehabilitation for Brain Injury (NCT NCT01120756)

Results Overview

We computed a composite measure based upon the average of individuals' scores on commonly used neuropsychological tests of attention, working memory, and executive functions. To compute this composite score, we first scored individual performances on each neuropsychological measure utilizing published norms, adjusted for, when available, age, gender, ethnicity, and education levels. We then converted all resultant scores (e.g., T-scores, Standard Scores) to a common metric, z-scores. (Z-scores are a standardized unit of measurement, scaled in terms of standard deviation (SD) units. Thus, a z-score of 0 represents the mean; a z-score of 1 represents+1 SD above the mean; and a z-score of -1 represents -1 SD below the mean.) Finally, for each participant, z-scores derived from each separate neuropsychological test were averaged together to yield a final composite score. The composite score was the unit of analysis.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

Baseline, Within 2-3 weeks Post-intervention

Results posted on

2019-08-02

Participant Flow

Participant milestones

Participant milestones
Measure	Goal-oriented Attentional Self-regulation Training Goal-oriented attentional self-regulation training (GOALS). This will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). In brief, the GBSM training protocol is designed to maximize the potential for improving attention regulation skills and the goal-directed functions they support, applying mindfulness-based attention regulation training to practice in redirecting attention to goal-relevant processes especially in the context of distractions is emphasized throughout training. Participants are asked to identify realistic functional goals as feasible individual and group projects, and are then trained in goal management strategies on the functional task(s) of their choice.	Brain Health Education Brain Health Education (EDU) Brain Health Education: Brain Health Education (EDU) will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education in health and brain injury in a classroom format, with study materials for homework.
Overall Study STARTED	21	14
Overall Study COMPLETED	20	13
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Goal-oriented Attentional Self-regulation Training Goal-oriented attentional self-regulation training (GOALS). This will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). In brief, the GBSM training protocol is designed to maximize the potential for improving attention regulation skills and the goal-directed functions they support, applying mindfulness-based attention regulation training to practice in redirecting attention to goal-relevant processes especially in the context of distractions is emphasized throughout training. Participants are asked to identify realistic functional goals as feasible individual and group projects, and are then trained in goal management strategies on the functional task(s) of their choice.	Brain Health Education Brain Health Education (EDU) Brain Health Education: Brain Health Education (EDU) will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education in health and brain injury in a classroom format, with study materials for homework.
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Goal-oriented Attentional Self-regulation Training n=21 Participants Goal-oriented attentional self-regulation training (GOALS). This will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). In brief, the GBSM training protocol is designed to maximize the potential for improving attention regulation skills and the goal-directed functions they support, applying mindfulness-based attention regulation training to practice in redirecting attention to goal-relevant processes especially in the context of distractions is emphasized throughout training. Participants are asked to identify realistic functional goals as feasible individual and group projects, and are then trained in goal management strategies on the functional task(s) of their choice.	Brain Health Education n=14 Participants Brain Health Education (EDU) Brain Health Education: Brain Health Education (EDU) will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education in health and brain injury in a classroom format, with study materials for homework.	Total n=35 Participants Total of all reporting groups
Age, Continuous	43 years STANDARD_DEVIATION 11 • n=21 Participants	43 years STANDARD_DEVIATION 11 • n=14 Participants	43 years STANDARD_DEVIATION 11 • n=35 Participants
Sex: Female, Male Female	18 Participants n=21 Participants	12 Participants n=14 Participants	30 Participants n=35 Participants
Sex: Female, Male Male	3 Participants n=21 Participants	2 Participants n=14 Participants	5 Participants n=35 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	21 Participants n=21 Participants	14 Participants n=14 Participants	35 Participants n=35 Participants

PRIMARY outcome

Timeframe: Baseline, Within 2-3 weeks Post-intervention

Population: We lost a total of n=2 participants to attrition from baseline to follow-up. This included n=1 from the Goal-Oriented Attentional Self-regulation training and n=1 from the Brain Health Education.

We computed a composite measure based upon the average of individuals' scores on commonly used neuropsychological tests of attention, working memory, and executive functions. To compute this composite score, we first scored individual performances on each neuropsychological measure utilizing published norms, adjusted for, when available, age, gender, ethnicity, and education levels. We then converted all resultant scores (e.g., T-scores, Standard Scores) to a common metric, z-scores. (Z-scores are a standardized unit of measurement, scaled in terms of standard deviation (SD) units. Thus, a z-score of 0 represents the mean; a z-score of 1 represents+1 SD above the mean; and a z-score of -1 represents -1 SD below the mean.) Finally, for each participant, z-scores derived from each separate neuropsychological test were averaged together to yield a final composite score. The composite score was the unit of analysis.

Outcome measures

Outcome measures
Measure	Goal-oriented Attentional Self-regulation Training n=20 Participants Goal-oriented attentional self-regulation training (GOALS). This will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). In brief, the GBSM training protocol is designed to maximize the potential for improving attention regulation skills and the goal-directed functions they support, applying mindfulness-based attention regulation training to practice in redirecting attention to goal-relevant processes especially in the context of distractions is emphasized throughout training. Participants are asked to identify realistic functional goals as feasible individual and group projects, and are then trained in goal management strategies on the functional task(s) of their choice.	Brain Health Education n=13 Participants Brain Health Education (EDU) Brain Health Education: Brain Health Education (EDU) will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education in health and brain injury in a classroom format, with study materials for homework.
Change From Baseline on a Composite Measure (Z-score) of Attention, Working Memory, and Executive Functions	0.26 Change to Z (composite) score Standard Deviation .27	.01 Change to Z (composite) score Standard Deviation .25

SECONDARY outcome

Timeframe: Baseline, 2-3 Weeks Post-intervention

Population: This measurement was used for the comparison of Goal-oriented attentional self-regulation training and Brain Health Education interventions. Also, we lost a total of n=2 participants to attrition from baseline to follow-up. This included n=1 from the Goal-Oriented Attentional Self-regulation training and n=1 from the Brain Health Education.

Observed measures of functional performance on complex tasks were assessed for the GOALS and Brain Health Education study. The overall composite score comprises scores for planning, initiation, self-monitoring, maintenance of attention, sequencing and switching, divergent thinking, execution, learning and memory. Scores range from 1-10. Changes were calculated from pre-to post-training, and higher scores indicate improvement in functioning.

Outcome measures

Outcome measures
Measure	Goal-oriented Attentional Self-regulation Training n=20 Participants Goal-oriented attentional self-regulation training (GOALS). This will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). In brief, the GBSM training protocol is designed to maximize the potential for improving attention regulation skills and the goal-directed functions they support, applying mindfulness-based attention regulation training to practice in redirecting attention to goal-relevant processes especially in the context of distractions is emphasized throughout training. Participants are asked to identify realistic functional goals as feasible individual and group projects, and are then trained in goal management strategies on the functional task(s) of their choice.	Brain Health Education n=13 Participants Brain Health Education (EDU) Brain Health Education: Brain Health Education (EDU) will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education in health and brain injury in a classroom format, with study materials for homework.
Functional Evaluations: Change From Baseline on the Goal Processing Scale	1.05 units on a scale Standard Deviation 1.15	.01 units on a scale Standard Deviation 0.25

Adverse Events

Goal-oriented Attentional Self-regulation Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Brain Health Education

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

Anthony Chen, MD

VA Northern California

Phone: 925-372-2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place