Cognitive Rehabilitation and Brain Activity of Attention-Control Impairment in TBI
NCT ID: NCT04199130
Last Updated: 2021-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-09-30
2021-09-17
Brief Summary
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Detailed Description
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These interventions will be compared to the standard of care, to each other, and their combined effectiveness will be assessed. Groups will consist of randomized individuals with moderate-to-severe TBIs who experience attention deficits. Each treatment will be administered for 4 weeks and two intervention groups will be used to counterbalance treatment order. Group 1 will receive BrainHQ first followed by GMT, while Group 2 will receive GMT first followed by BrainHQ. In addition a third group will serve as a treatment-as-usual control group.
Primary outcomes include measures of self-care, ability, adjustment and participation. Secondary outcomes include measures of cognition and brain function. And lastly, tertiary outcomes include measures of emotional and psychosocial functioning. These outcomes will be measures at baseline, following completion of the first 4 week treatment in both groups (Group 1 = BrainHQ while Group 2 = GMT), and following completion of the second 4 week treatment in both groups (Group 1 = GMT while Group 2 = BrainHQ).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
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Intervention Group 1
This arm will receive BrainHQ for the first four weeks of the study, and Goal Management Training for the second four weeks.
BrainHQ
BrainHQ is a web-based "brain-training" program. The investigators will assign participants to attention specific modules that they will complete at home with the goal of "restoring" attentional functions lost through injury via repetitive tasks of graded difficulty.
Goal Management Training
This is a manualized, interactive, metacognitive-strategy training designed to promote a mindful approach to complex real-life tasks and reduce lapses in attention via implementation of "compensatory" mechanisms for monitoring tasks.
Intervention Group 2
This arm will receive Goal Management Training for the first four weeks of the study, and BrainHQ for the second four weeks.
BrainHQ
BrainHQ is a web-based "brain-training" program. The investigators will assign participants to attention specific modules that they will complete at home with the goal of "restoring" attentional functions lost through injury via repetitive tasks of graded difficulty.
Goal Management Training
This is a manualized, interactive, metacognitive-strategy training designed to promote a mindful approach to complex real-life tasks and reduce lapses in attention via implementation of "compensatory" mechanisms for monitoring tasks.
Treatment-as-usual
No interventions assigned to this group
Interventions
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BrainHQ
BrainHQ is a web-based "brain-training" program. The investigators will assign participants to attention specific modules that they will complete at home with the goal of "restoring" attentional functions lost through injury via repetitive tasks of graded difficulty.
Goal Management Training
This is a manualized, interactive, metacognitive-strategy training designed to promote a mindful approach to complex real-life tasks and reduce lapses in attention via implementation of "compensatory" mechanisms for monitoring tasks.
Eligibility Criteria
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Inclusion Criteria
* Ruff 2 \& 7 selective attention task score ≤ 1.5 standard deviations from demographically-matched norms
* Able to participate in study at 12-60 months post-injury without contraindications
* Willingness to be randomized and to participate in treatment procedures
* Capacity to visit the laboratory for repeated treatment sessions and testing
* Access to internet-enabled home computer
* English as native language
* Adequate reading comprehension to allow completion of questionnaires
* Reliable digit span (RDS) score \> 7
Exclusion Criteria
* Current alcohol or drug use
* Pre-existing severe psychiatric disorder (e.g., schizophrenia) detected by Mental Screening form, 3rd edition (MHS-III) or history of psychiatric diagnosis sufficiently severe to have resulted in inpatient hospitalization
* Current suicidal/homicidal ideation or intent
* Reported involvement in current litigation
* Reported history of pre-injury learning disability
* Not competent to provide written informed consent (i.e., not able to demonstrate understanding or expectations of study and potential risks of participation)
* Does not fully understand the nature of the study and requirements of participation
* Does not understand task instructions
* Validity testing (score ≤ 7) on the RDS 22 test of suboptimal/non-credible performance taken from the forward and backward digit span subtests of the WAIS-IV
21 Years
55 Years
ALL
No
Sponsors
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University of Florida
OTHER
Responsible Party
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Locations
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College of Public Health and Health Professions, University of Florida
Gainesville, Florida, United States
Countries
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Other Identifiers
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IRB201902218
Identifier Type: -
Identifier Source: org_study_id