Training in Goal-directed Attention Regulation for Individuals With Brain Injury
|ClinicalTrials.gov Identifier: NCT01035606|
Recruitment Status : Completed
First Posted : December 18, 2009
Results First Posted : October 20, 2017
Last Update Posted : October 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Brain Injury||Behavioral: training in goal-directed attention regulation Behavioral: brain health education Behavioral: computer-assisted training in goal-directed attention regulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
The design for Arms 1 and 2 was a cross-over design. Half the participants completed Arm 1 first and then crossed-over to Arm 2; the remaining half completed Arm 2 first and then crossed-over to Arm 1. Thus, all participants completed both Arm 1 and 2.
Arm 3 represented a parallel study. Participants enrolled in this arm did not cross-over to any other condition.
|Masking:||None (Open Label)|
|Official Title:||Plasticity in Brain Network to Enhance Cognitive Rehabilitation|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||April 2017|
Experimental: Goal-oriented Attention Regulation Training
training in goal-directed attention regulation
Behavioral: training in goal-directed attention regulation
training in goal-directed attention regulation
Active Comparator: Education
brain health education
Behavioral: brain health education
brain health education workshops
Experimental: Technology-assisted Goal-directed Self-Regulation Training
computer-assisted training in goal-directed attention regulation
Behavioral: 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 [ Time Frame: 5 Weeks (After completion of active trainings in Arm 1 and Arm 3) ]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.
- Change From Baseline to Post-training for Task Errors on a Functional Performance Measure [ Time Frame: 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).
- Change to Attention and Executive Functioning Composite Scores [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01035606
|United States, California|
|VA Northern California Health Care System, Mather, CA|
|Sacramento, California, United States, 95655|
|Principal Investigator:||Mark D'Esposito, MD||VA Northern California Health Care System, Mather, CA|