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

Primary Purpose

Traumatic Brain Injury

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BrainHQ

Goal Management Training

About this trial

This is an interventional supportive care trial for Traumatic Brain Injury

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

College of Public Health and Health Professions, University of Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group 1

Intervention Group 2

Treatment-as-usual

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04199130

First Posted

December 12, 2019

Last Updated

November 15, 2021

Sponsor

University of Florida

1. Study Identification

Unique Protocol Identification Number

NCT04199130

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Closed with the IRB due to slow enrollment during COVID. Will be modifying the study with a new submission.

Study Start Date

September 2021 (Anticipated)

Primary Completion Date

September 17, 2021 (Actual)

Study Completion Date

September 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Brain Injury

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Described in study description

Masking

Participant

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group 1

Arm Type

Experimental

Arm Description

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

Arm Title

Intervention Group 2

Arm Type

Experimental

Arm Description

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

Arm Title

Treatment-as-usual

Arm Type

No Intervention

Intervention Type

Behavioral

Intervention Name(s)

BrainHQ

Intervention Description

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 Type

Behavioral

Intervention Name(s)

Goal Management Training

Intervention Description

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.

Primary Outcome Measure Information:

Title

Measurement of change in self-care

Description

Time Frame

Measured at Baseline, Post treatment 1 (4 weeks post-baseline), Post treatment 2 (8 weeks post baseline)

Title

Measurement of change in ability, adjustment and participation

Description

Time Frame

Measured at Baseline, Post treatment 1 (4 weeks post-baseline), Post treatment 2 (8 weeks post baseline)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

College of Public Health and Health Professions, University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32611

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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