Strengthening Neuro-Cognitive Skills for Success in School, Work and Beyond
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorVA Office of Research and Development
About this trial
For many Veterans, success in achieving goals at work, school and in other aspects of life are top priorities. The abilities to regulate attention, remember key information, and stay calm and on track are fundamental to this success. Unfortunately, Veterans who have experienced a traumatic brain injury (TBI) often struggle with these very abilities, and a number of barriers can make it difficult for them to access the help Veterans need. Tele-rehabilitation has the potential to overcome some of these barriers and increase access to care, enabling providers to better reach Veterans 'where they are' in their communities. This project will assess two different approaches to brain injury rehabilitation that seek to help Veterans build personal strengths to better accomplish their goals. Both approaches will be delivered remotely via tele-rehabilitation and augmented by digital apps to best support Veterans' learning in community settings outside the VA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Post 9/11 Veterans
age 21-60; with history of mild-moderate TBI (including reported mechanism of head injury and alteration of consciousness);
in the chronic, stable phase of recovery (>6 months from injury); with at least 1 self-reported cognitive symptom, --including difficulties with working memory; and interested in goal-setting and intensive training.
Disqualifiers
Severely apathetic/abulic, aphasic, or other reasons for being unable or unwilling to participate in training;
severe cognitive dysfunction (below 2 standard deviations on two composite cognitive domains);
schizophrenia;
bipolar disorder;
Trial design
Design model
Parallel
Treatments tested in this trial
BrainStrong-GSR
BehavioralGoal-directed State Regulation Training (GSR)
BrainStrong-OPT
BehavioralOptimization of Brain Functioning (OPT)
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: BrainStrong-GSRExperimental treatment 1 intervention
Group B: BrainStrong-OPTActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Selective Information Processing
In order to test a primary hypothesis related to potential intervention mechanisms, the investigators will use the well-established Automated Operation Span Task (OSPAN) to measure working memory in the presence of distractions. Specifically, the OSPAN sums correctly recalled and ordered items from a memory set in the presence of distractors. The investigators elected to use this psychometric measure due to its sensitivity, precision, and test-retest stability in order to maximize the ability to detect longitudinal changes on the primary outcome of interest.
Time frame
Change from baseline to 2 weeks post-interventionSecondary outcomes
1
Observed Functional performance
The Goal Processing Scale (GPS) measures goal-directed functioning in a complex, ecologically-valid setting. This timed procedure requires participants gather information on three different self-selected activities. Throughout the task, participants are required to follow specific rules and manage unanticipated challenges (e.g., distractions). Evaluators, following a well-specified manual, rate participants' performance across multiple domains of functioning (e.g., maintaining attention in a distracting environment, cognitive flexibility) while they complete the task. The outcome variable of interest will be changes to the GPS total score. GPS scores range from 0 - 10, with higher scores reflecting better goal-directed functioning. Positive change scores will reflect pre-post training improvements to goal-directed functioning, with negative change scores reflecting pre-post worsening of goal-directed functioning.
Time frame
2 weeks post-intervention, 3 months post-intervention2
Progress Towards Goal Attainment
Goal Attainment Scaling (GAS) procedures will be used for setting and measuring progress toward participant goals. GAS is a six-step process to quantify clinically meaningful change. GAS is a highly individualized but quantitative outcome measure. Participants will define goals to complete and identify objective and observable outcomes for each goal, consisting of outcomes both better and worse than anticipated. Participants weigh goals based upon their estimated difficulty level and priority. GAS scores range from -2 to +2, with negative scores indicating participants achieved less than expected, a score of "0" indicating that participants achieved at expectation, and positive scores indicating that participants scored better than expected. The outcome of interest will be the weighted average of each GAS score evaluated post-intervention.
Time frame
3 months post-interventionSponsors and contacts
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Source ClinicalTrials.gov