Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Mild Traumatic Brain Injury
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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).Masking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 19 years and 55 years
Gender
Both males and females

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 Veteran...

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.

Tracking Information

NCT #
NCT04044456
Collaborators
Not Provided
Investigators
Principal Investigator: Julia K. Waid-Ebbs, PhD North Florida/South Georgia Veterans Health System, Gainesville, FL