Trial Outcomes & Findings for Training in Goal-directed Attention Regulation for Individuals With Brain Injury (NCT NCT01035606)

Last Updated: 2017-10-20

Results Overview

Responses to goal processing questionnaire relating to areas of personal goal-based functioning. This scale measured participants self-perceived changes to their cognitive and emotional functioning. Participants indicated the degree to which they perceived changes to 11 questions after receiving trainings in Arm 1 and Arm 3 on a 10-point scale (1=domain became worse, 5 = no change, 10 = domain improved). Participants did not complete this measure after Arm 2.

Recruitment status

COMPLETED

Study phase

Target enrollment

49 participants

Primary outcome timeframe

5 Weeks (After completion of active trainings in Arm 1 and Arm 3)

Results posted on

2017-10-20

Participant Flow

Participants were referred for this study by their physicians and treatment providers due to history of acquired brain injury and chronic cognitive complaints involving distractibility and difficulties with problem solving, organization, and multitasking

Participant milestones

Participant milestones
Measure	Goal-oriented Attention Regulation Training Therapist-guided training in goal-oriented attention regulation in a group format	Education brain health education brain health education: brain health education workshops	Technology-assisted Goal-directed Self-Regulation Training computer-assisted training in goal-directed attention regulation: computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills
Overall Study STARTED	19	19	11
Overall Study COMPLETED	16	16	7
Overall Study NOT COMPLETED	3	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Goal-oriented Attention Regulation Training Therapist-guided training in goal-oriented attention regulation in a group format	Education brain health education brain health education: brain health education workshops	Technology-assisted Goal-directed Self-Regulation Training computer-assisted training in goal-directed attention regulation: computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills
Overall Study change in health, job demands,family	3	3	4

Baseline Characteristics

Training in Goal-directed Attention Regulation for Individuals With Brain Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Goal-oriented Attention Regulation Training n=19 Participants training in goal-directed attention regulation training in goal-directed attention regulation: training in goal-directed attention regulation	Education n=19 Participants brain health education brain health education: brain health education workshops	Technology-assisted Goal-directed Self-Regulation Training n=11 Participants computer-assisted training in goal-directed attention regulation computer-assisted training in goal-directed attention regulation: computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills	Total n=49 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	19 Participants n=7 Participants	11 Participants n=5 Participants	49 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	50.4 years STANDARD_DEVIATION 12.2 • n=5 Participants	50.4 years STANDARD_DEVIATION 12.2 • n=7 Participants	51.8 years STANDARD_DEVIATION 12.0 • n=5 Participants	51.1 years STANDARD_DEVIATION 12.1 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	0 Participants n=5 Participants	20 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	29 Participants n=4 Participants
Region of Enrollment United States	19 participants n=5 Participants	19 participants n=7 Participants	11 participants n=5 Participants	49 participants n=4 Participants

PRIMARY outcome

Timeframe: 5 Weeks (After completion of active trainings in Arm 1 and Arm 3)

Outcome measures

Outcome measures
Measure	Goal-oriented Attention Regulation Training n=16 Participants Training in goal-directed attention regulation Training in goal-directed attention regulation: training in goal-directed attention regulation	Education brain health education brain health education: brain health education workshops	Technology-assisted Goal-directed Self-Regulation Training n=7 Participants computer-assisted training in goal-directed attention regulation computer-assisted training in goal-directed attention regulation: computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills
Self-report Stop and Relax during stressful times	7.79 units on a scale Standard Deviation 1.39	—	6.49 units on a scale Standard Deviation 1.38
Self-report Stop and Refocus on current goals	7.61 units on a scale Standard Deviation 1.36	—	7.73 units on a scale Standard Deviation 1.12
Self-report Divide a complex task into more manageable tasks	7.60 units on a scale Standard Deviation 1.15	—	6.89 units on a scale Standard Deviation 1.26
Self-report Hold information in mind	7.19 units on a scale Standard Deviation 1.06	—	6.83 units on a scale Standard Deviation 1.82
Self-report Complete tasks	7.15 units on a scale Standard Deviation 1.44	—	7.3 units on a scale Standard Deviation 1.42
Self-report Interact in social settings	7.08 units on a scale Standard Deviation 1.25	—	5.2 units on a scale Standard Deviation 0.70
Self-report Choose feasible daily goals to accomplish	7.07 units on a scale Standard Deviation 1.07	—	6.99 units on a scale Standard Deviation 1.40
Self-report Prioritize	6.96 units on a scale Standard Deviation 1.01	—	7.24 units on a scale Standard Deviation 1.41
Self-report Manage energy	6.52 units on a scale Standard Deviation 1.16	—	6.29 units on a scale Standard Deviation 1.46
Self-report Manage distractions	6.29 units on a scale Standard Deviation 1.23	—	6.47 units on a scale Standard Deviation 1.32
Self-report Manage anxiety	6.16 units on a scale Standard Deviation 1.6	—	5.24 units on a scale Standard Deviation 1.24

SECONDARY outcome

Timeframe: 5 weeks (After completion of Arm 1 and Arm 2)

Participants completed a functional assessment task, the modified Multiple Errands Task (MET). The MET is an unstructured functional task that permits assessment of participants' abilities to follow outlined rules and complete multiple 'real-world' tasks in a limited time period. Participants were provided written instructions and a map of the hospital where the assessment took place, and were instructed to complete 12 subtasks in 40 minutes while following 9 specified rules. Participants completed this at task at baseline and following Training (Arms 1 \& 2, but not 3). Outcome measure was computed as post-training - baseline (negative value reflects less errors made post-training).

Outcome measures

Outcome measures
Measure	Goal-oriented Attention Regulation Training n=16 Participants Training in goal-directed attention regulation Training in goal-directed attention regulation: training in goal-directed attention regulation	Education n=16 Participants brain health education brain health education: brain health education workshops	Technology-assisted Goal-directed Self-Regulation Training computer-assisted training in goal-directed attention regulation computer-assisted training in goal-directed attention regulation: computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills
Change From Baseline to Post-training for Task Errors on a Functional Performance Measure	-3.7 Number of task failures Standard Deviation 2.8	-1.8 Number of task failures Standard Deviation 3.5	—

SECONDARY outcome

Timeframe: 5 weeks (After completion of Arm 1 and Arm 2)

Participants completed the following neuropsychological measures of attention and executive functions before and after Arms 1 and 2, but not Arm 3. Letter Number Sequencing from WIAT-III; Auditory Consonant Trigram: 9,18, 36 seconds; Digit Vigilance Test (Time and Errors); DKEFS subtests: Design Fluency, Verbal Fluency Switching, Inhibition (Time and Errors); and Inhibition/Switching (Time and Errors); and Trails B. Performance on these measures were scored based upon age, and when available, educational and repeated administration norms. Resultant scores were transformed into z-scores and aggregated to form a composite measure. Higher z-scores reflect better functioning. The unit of analysis for this outcome was the change score from baseline to post-training. Positive change scores reflect improved performance over time\[post-training - baseline\], whereas negative change scores reflect worsening performance over time.

Outcome measures

Outcome measures
Measure	Goal-oriented Attention Regulation Training n=16 Participants Training in goal-directed attention regulation Training in goal-directed attention regulation: training in goal-directed attention regulation	Education n=8 Participants brain health education brain health education: brain health education workshops	Technology-assisted Goal-directed Self-Regulation Training computer-assisted training in goal-directed attention regulation computer-assisted training in goal-directed attention regulation: computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills
Change to Attention and Executive Functioning Composite Scores	0.82 Aggregate Z-scores Standard Deviation 0.20	0.03 Aggregate Z-scores Standard Deviation 0.11	—

Adverse Events

Goal-oriented Attention Regulation Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Technology-assisted Goal-directed Self-Regulation Training

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