Comparing Telehealth to In-person a Combined Metacognitive Training in Veterans With mTBI/PTSD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-55
SponsorVA Office of Research and Development
About this trial
Veterans with mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) commonly experience cognitive impairments including attention and executive function deficits that interfere with their ability to engage in productive personal and social activities. Of the limited interventions available to address cognition, none rigorously train attention beyond strategy management. This study will evaluate an innovatively combined strategy training known as Goal Management Training plus computerized attention training in Veterans with mTBI/PTSD. Preliminary testing suggests an effectiveness in improving problem solving, attention and functional tasks in a small number of Veterans. Considering these promising results, cost effectiveness, and the demand for access to care from Veterans living in rural areas, a Randomized Controlled Trial will determine and compare the effects of this treatment, administered either in-person or via telehealth, on executive function, attention, other aspects of cognition and real life functional tasks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Veterans who have served in OIF-OEF-OND and have been diagnosed with both a mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) based on the joint criteria of the Veterans' Affairs and Department of Defense (VA & DoD)
Latest mTBI occurred at least 6 months prior to study enrollment
Attention deficit of 1.5 SD below the mean of the RBANS attention index
Family member or friend that is willing to complete a questionnaire
Disqualifiers
History of pre-morbid learning disability
History of psychiatric diagnosis sufficiently severe to have resulted in inpatient hospitalization
Neurological disease unrelated to TBI (seizure disorder, stroke)
Score < 90 on National Adult Reading Test (NART)
Trial design
Design model
Parallel
Treatments tested in this trial
Goal Management Training plus Attention Training
BehavioralGMT is a Power Point directed interactive group training to use a five point strategy to plan and execute complex tasks. Attention Training utilizes Brain HQ attention modules and individualized attention goals.
Brain Health Workshop and National Geographic Movies
BehavioralBHW is a Power Point directed interactive training to learn about the brain and cognitive components. National Geographic Movies, participants select movies to watch with the therapists and answers questions regarding the content.
Treatment groups
63 Participants
are divided into 3 treatment groupsGroup A: Inpatient GMT plus Attention TrainingExperimental treatment 1 intervention
Group B: Telehealth GMT plus Attention TrainingExperimental treatment 1 intervention
Group C: Brain Health WorkshopPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in the Composite Executive score of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research
computerized performance measure that assess overall executive function. Composite Executive score, which is a single score that represent performance across the Dot Counting, N-back, Flanker, Continuous Performance Test, Fluency subscales, with a range of -3.0 to 3.0 with higher scores indicating better executive function.
Time frame
pre-intervention, post, 6-month and 1-year follow-upSecondary outcomes
1
Change in the Test of Grocery Shopping Skills
Functional task that measures efficiency of shopping for 10-items in an actual grocery store. Variables include Total Time and number of redundant Aisles, with less time and redundant Aisles indicating better performance.
Time frame
week 1, week 112
Change in the attention index of the Repeatable Battery for the Assessment of Neuropsychological Status
performance measure of digit span and coding to measure attention. Range is 0-100 with higher scores indicating better attention.
Time frame
week 1, week 11, week 35 and week 593
Change in Attention Network Task
Experimental computer administered flanker task to measure alerting, orienting and executive control components of attention. Range is -200 to 200 with higher scores indicating more impairment.
Time frame
week 1, week 11, week 35 and week 594
Change in Traumatic Brain Injury-Quality of Life, Participation Ability and Satisfaction short-form
Self-report questionnaire to measure participation, range is 59-295 with higher scores indicating better participation
Time frame
week 1, week 11, week 35 and week 59Sponsors and contacts
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Source ClinicalTrials.gov