Cognitive Rehabilitation and Brain Activity of Attention-Control Impairment in TBI

Not Applicable

Withdrawn

Brief Summary: The purpose of this research study is to develop a method to improve thinking difficulties in individuals who have experienced a traumatic brain injury and report experiencing difficulties in attention and concentration. This study aims to understand how cognitive rehabilitation of attention difficulties affects brain activity.

Detailed Description: This study will compare the effectiveness of two different types of cognitive rehabilitation in moderate-to-severe (m/s) traumatic brain injury (TBI) survivors. More specifically comparisons will be made between Direct Attention Training administered via BrainHQ, and Metacognitive Strategy Training in the form of the evidence-based Goal Management Training (GMT) protocol.

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).

Recruitment & Eligibility

Inclusion Criteria

Self-report of attention problems, confirmed with psychometric testing
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

Pre-existing neurological disorder associated with cerebral dysfunction (e.g., stroke, history of epilepsy or chronic seizure disorder)
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

Arm && Interventions

Group	Intervention	Description
Intervention Group 2	BrainHQ	This arm will receive Goal Management Training for the first four weeks of the study, and BrainHQ for the second four weeks.
Intervention Group 1	Goal Management Training	This arm will receive BrainHQ for the first four weeks of the study, and Goal Management Training for the second four weeks.
Intervention Group 1	BrainHQ	This arm will receive BrainHQ for the first four weeks of the study, and Goal Management Training for the second four weeks.
Intervention Group 2	Goal Management Training	This arm will receive Goal Management Training for the first four weeks of the study, and BrainHQ for the second four weeks.

Primary Outcome Measures

Name	Time	Method
Measurement of change in self-care	Measured at Baseline, Post treatment 1 (4 weeks post-baseline), Post treatment 2 (8 weeks post baseline)	These will be measured via the Timed Instrumental Activities of Daily Living assessment. Participants will be timed performing common functional tasks and longer completion times indicate greater impairment.
Measurement of change in ability, adjustment and participation	Measured at Baseline, Post treatment 1 (4 weeks post-baseline), Post treatment 2 (8 weeks post baseline)	A composite self-report questionnaire known as the Mayo-Portland Adaptability Inventory will be used to measure functioning across these domains. This measures uses a scale from 0 to 4. The higher the score the more severe the impairment.

Secondary Outcome Measures

Name	Time	Method

Locations (1): College of Public Health and Health Professions, University of Florida
🇺🇸
Gainesville, Florida, United States