NCT04199130

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

Effectiveness of Combined Attention and Metacognitive-strategy Training Approaches to Cognitive Impairment in Moderate-to-severe TBI

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2021-09-01
• Primary completion: 2021-09-17
• Completion: 2021-09-17
• First posted: 2019-12-13
• Last updated: 2021-11-22

Locations

1 site across 1 country: United States