Training in Goal-directed Attention Regulation for Individuals With Brain Injury
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|