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

NCT04199130 | Withdrawn

• 1 other identifier: IRB201902218
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (3)

Intervention Group 1

EXPERIMENTAL

This arm will receive BrainHQ for the first four weeks of the study, and Goal Management Training for the second four weeks.

Behavioral: BrainHQ; Behavioral: Goal Management Training

Intervention Group 2

EXPERIMENTAL

This arm will receive Goal Management Training for the first four weeks of the study, and BrainHQ for the second four weeks.

Behavioral: BrainHQ; Behavioral: Goal Management Training

Treatment-as-usual

NO INTERVENTION

Interventions

BrainHQ BEHAVIORAL

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.

Intervention Group 1; Intervention Group 2

Goal Management Training BEHAVIORAL

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 1; Intervention Group 2

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

College of Public Health and Health Professions, University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Described in study description

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 13, 2019
• Study Start: September 1, 2021
• Primary Completion: September 17, 2021
• Study Completion: September 17, 2021
• Last Updated: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)