Clinical trial NCT04199130: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Described in study description
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Measurement of change in self-care
timeFrame: Measured at Baseline, Post treatment 1 (4 weeks post-baseline), Post treatment 2 (8 weeks post baseline)
measure: Measurement of change in ability, adjustment and participation
timeFrame: Measured at Baseline, Post treatment 1 (4 weeks post-baseline), Post treatment 2 (8 weeks post baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: College of Public Health and Health Professions, University of Florida
state: Florida
Study officials:
References: