Recruiting

Telehealth & In-person

Sponsor:

VA Office of Research and Development

Code:

NCT05380050

Conditions

Brain Injury

Cognition

PTSD

Intervention

Eligibility Criteria

Sex: All

Age: 30 - 55

Healthy Volunteers: Not accepted

Interventions

Goal Management Training plus Attention Training

Brain Health Workshop and National Geographic Movies

Study Details

Brief summary:

Veterans with mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) commonly experience cognitive impairments including attention and executive function deficits that interfere with their ability to engage in productive personal and social activities. Of the limited interventions available to address cognition, none rigorously train attention beyond strategy management. This study will evaluate an innovatively combined strategy training known as Goal Management Training plus computerized attention training in Veterans with mTBI/PTSD. Preliminary testing suggests an effectiveness in improving problem solving, attention and functional tasks in a small number of Veterans. Considering these promising results, cost effectiveness, and the demand for access to care from Veterans living in rural areas, a Randomized Controlled Trial will determine and compare the effects of this treatment, administered either in-person or via telehealth, on executive function, attention, other aspects of cognition and real life functional tasks.

Conditions

Brain Injury

Cognition

PTSD

Intervention

Study ID

NCT05380050

Start date

Nov 1, 2022

Status verified date

Oct, 2025

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Veterans who have served in OIF-OEF-OND and have been diagnosed with both a mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) based on the joint criteria of the Veterans' Affairs and Department of Defense (VA \& DoD).
  • Latest mTBI occurred at least 6 months prior to study enrollment.
  • Attention deficit of 1.5 SD below the mean of the RBANS attention index.
  • Family member or friend that is willing to complete a questionnaire.
  • 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 the Test of Memory Malingering (TOMM).
  • Reported alcohol or substance abuse within the past year.
  • Reported involvement in current litigation related to injury.
  • 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.

Study Design

Enrollment

63 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Inpatient GMT plus Attention Training

Goal Management Training is a group metacognitive intervention to improve ability to complete complex task more effectively. 2-hour session are conducted in-person weekly over 10-weeks. A second weekly session includes Attention training which is conducted one-on-one with the therapist in the clinic. Participant completed 5-6 hours of homework between sessions.

experimental: Telehealth GMT plus Attention Training

Goal Management Training is a group metacognitive intervention to improve ability to complete complex task more effectively. 2-hour session are conducted over the VA VideoConnect weekly over 10-weeks. A second weekly session includes Attention training which is conducted one-on-one with the therapist via VA VideoConnect. Participant completed 5-6 hours of homework between sessions

placebo comparator: Brain Health Workshop

Brain Health Workshop includes educational information about the brain to control for GMT and National Geographic Movies is used as a control to equate time with therapist in Attention Training. Each session occurs weekly for 2-hours over 10-weeks.

Interventions

Goal Management Training plus Attention Training

GMT is a Power Point directed interactive group training to use a five point strategy to plan and execute complex tasks. Attention Training utilizes Brain HQ attention modules and individualized attention goals.

Brain Health Workshop and National Geographic Movies

BHW is a Power Point directed interactive training to learn about the brain and cognitive components. National Geographic Movies, participants select movies to watch with the therapists and answers questions regarding the content.

Primary outcome measure

  • Change in the Composite Executive score of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research [ Time Frame: pre-intervention, post, 6-month and 1-year follow-up ]

Central Contacts and Locations

Central contacts

Margaret H McCallum

(352) 376-1611Margaret.McCallum@va.gov

Locations

North Florida/South Georgia Veterans Health System, Gainesville, FL

Recruiting

Gainesville, Florida, United States, 32608-1135

Contacts

Julia K Waid-Ebbs, PhD

(352) 376-1611Julia.Waid-Ebbs@va.gov

Principal Investigator:

Julia K. Waid-Ebbs, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Oct 21, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-10-21.