Clinical trial NCT04044456: Combining Attention and Metacognitive Training to Improve Goal Directed Behavior in Veterans With TBI
Official title: Combining Attention and Metacognitive Training to Improve Goal Directed Behavior in Veterans With TBI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Traumatic Brain Injury
Keywords: Brain Injury
Cognition
Veteran
Attention
Metacognition
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-08-05
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants meeting inclusion criteria will be randomized to either treatment (Goal management training and attention training) or control (Brain Health Workshop and national geographic movies).
Primary purpose: TREATMENT

Brief summary: Veterans with mild traumatic brain injury continue to deal with symptoms that interfere with their ability to engage in productive activities. In combination with other psychosocial difficulties, impairments are found in cognition, such as attention and executive function. Few interventions are available to treat attention in Veterans with mTBI. Of the interventions available, none rigorously train attention combined with strategy training. This project will innovatively combine a strategy training called Goal Management Training with computerized attention training to improve tests of problem solving, attention and functional tasks compared to a control group.

Detailed description: This is a pilot study to test the effect of GMT plus Attention Training for Veterans with chronic mTBI. The research design is a parallel study with randomization to treatment or control with test administration at pre/post and six months following treatment. The investigators will enroll 50 Veterans with a diagnosis mTBI between the ages of 18 to 55, that demonstrate a deficit in attention, pass effort testing and have not changed psychotropic medication within the past two weeks. Treatment utilizes GMT for 10-weekly two-hour sessions and Brain HQ/Attention Process Training III for 10-weekly two-hour sessions. Control utilizes a complimentary Brain Health Workshop for 10-weely two-hour sessions and National Geographic movies for 10-weekly two-hour sessions.

Aim 1: Determine the treatment effect of attention training combined with GMT in Veterans with mTBI.

Hypothesis 1: GMT plus attention training will significantly improve performance on tests of cognition compared to the control group.

Primary measure: Computerized Tower of London (cTOL) total time, time to first move and optimal moves). The investigators have found significant improvement in cTOL following GMT in previous cohorts of Veterans with blast-related mTBI and anticipate improvement following a combined intervention.

Secondary measure: Attention Network Task (ANT) reaction time and errors for one or all dissociable components of three attentional systems (orienting, alerting, executive control) following intervention. There is little understanding of components of impaired attention and how it impacts executive function; therefore, there is limited guidance in shaping cognitive training. The investigators will conduct an experimental task (attention network task) that disassociates three attentional components (alerting, orienting, and executive control). The investigators will specifically target the orienting component of attention that is problematic for Veterans with mTBI and PTSD24, 26. Attentional processes are vital to goal-directed behavior. There is great potential in the use of these measures to identify individual differences (type of attention deficit) that could moderate treatment-related improvement and inform targeted interventions.

Hypothesis 2: Treatment gains will translate to functional activities compared to controls.

Primary measure of functional performance: test of grocery shopping skills (TOGSS) total time and optimal strategy use. The TOGSS captures efficiency in completing a real-world task and aligns with the strategy skills learned in GMT.

Secondary measure of community participation, the Community Reintegration of Servicemembers (CRIS) extent of participation. The CRIS demonstrated significant GMT treatment effect compared to controls in Veterans with mTBI. The combined treatment of attention training using drill training and implementing strategies to improve attention in a functional setting through GMT will potentiate treatment effect to functional activities. Measuring functional improvement through performance-based measures and self-report of engagement in activities will demonstrate treatment translation.

Tertiary analysis will be conducted on moderator variables: PTSD symptoms, Pain, History of Substance Abuse, Depression, number of concussions and combat exposure.

Successful completion of the proposed study will provide insight into the effectiveness of the innovative combined treatment of attention and executive function in Veterans with mTBI and PTSD. Use of the ANT could better target treatment and lead to future examination of attention treatment on neuroplasticity.

A multiple linear regression model will be used to determine if there is a significant association between treatment effect and comorbidities such as PTSD, depression, anxiety, pain, sleep, substance abuse, etc.

Eligibility criteria: Inclusion Criteria:

Veterans with a diagnosis mTBI between the ages of 18 to 55, that demonstrate a deficit in attention, pass effort testing and have not changed psychotropic medication within the past two weeks.

* all Veterans who have served in OIF-OEF-OND with single- (at least brief loss of conscious) or multiple (with at least alteration of consciousness) mild traumatic brain injury (mTBI) during deployment, who seek services at North Florida/South Georgia Veterans Health System (NF-VHS).
* TBI must have suffered their injury at least 6 months prior to study enrollment and currently be in stable neurological condition.
* age range 19-55 years to reduce the impact of aging on treatment improvement.
* Attention deficit of 1.5 SD below the mean of the RBANS attention index. This will ensure that participants have an objective deficit attention.
* Family member or friend that is willing to complete the BRIEF-A (BRIEF-A guidelines of face to face interaction with the participant at least twice a week) at all measurement time points.
* Access to a home computer, or smartphone with internet access.

Exclusion Criteria:

* History of pre-morbid learning disability
* History of psychiatric diagnosis sufficiently severe to have resulted in inpatient hospitalization.
* Neurological disease unrelated to TBI (seizure disorder, stroke)
* Score \< 90 on National Adult Reading Test (NART)
* Failure of validity testing on either the Test of Memory Malingering (TOMM),). Score of 45 or less on TOMM Trial 2 or retention trial.
* Reported alcohol or substance abuse within the past year
* Reported involvement in current litigation
* Recent change of medications for seizures, depression or memory.
* Currently enrolled in other cognitive therapy that cannot be discontinued
* Does not speak English fluently
* Not competent to provide consent (also, not able to demonstrate understanding of expectations of study and potential risks of participation).
* Uncontrolled, acute medical or psychiatric condition as indicated by the participant or observed by the research team member that would make it unsafe to participate in the research activities, i.e. precautions for active homicidal/suicidal intent, active psychosis, or acute symptoms requiring immediate medical attention.
* Psychotropic drugs that have changed within the past two-weeks that would impact performance during assessment.

Primary outcomes:
measure: Computerized Tower of London Average Time to Complete Problems/Total Time
timeFrame: week 1, 11, 36
measure: Test of Grocery Shopping Skills
timeFrame: week 1, 11
Secondary outcomes:
measure: Attention Network Task
timeFrame: week 1, 11, 36
measure: Community Reintegration of Service Members
timeFrame: week 1, 11, 36
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System, Gainesville, FL
state: Florida
Study officials:
affiliation: North Florida/South Georgia Veterans Health System, Gainesville, FL
name: Julia K. Waid-Ebbs, PhD
role: PRINCIPAL_INVESTIGATOR
References: