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

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.

Study Overview

• Status: Withdrawn
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Behavioral: BrainHQ; Behavioral: Goal Management Training

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).

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • College of Public Health and Health Professions, University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.
EXPERIMENTAL: 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.	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.
NO_INTERVENTION: Treatment-as-usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of change in self-care	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.	Measured at Baseline, Post treatment 1 (4 weeks post-baseline), Post treatment 2 (8 weeks post baseline)
Measurement of change in ability, adjustment and participation	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.	Measured at Baseline, Post treatment 1 (4 weeks post-baseline), Post treatment 2 (8 weeks post baseline)

Collaborators and Investigators

• Sponsor: University of Florida

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2021
• Primary Completion (ACTUAL): September 17, 2021
• Study Completion (ACTUAL): September 17, 2021

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (ACTUAL): December 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: IRB201902218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No