Training in Goal-Oriented Attention Self-Regulation Improves Executive Functioning in Veterans with Chronic Traumatic Brain Injury.
Tatjana Novakovic-Agopian, Erica Kornblith, Gary Abrams...
https://pubmed.ncbi.nlm.nih.gov/29717652Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID02920788
Multi-Level Assessment and Rehabilitation of Combat Mild Traumatic Brain Injury
Led by VA Office of Research and Development · Updated on 2026-05-06
65
Participants Needed
2
Research Sites
14 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of a cognitive training program called Goal-Oriented Attentional Self-Regulation (GOALS) on Veterans with chronic mild traumatic brain injury (mTBI) and related conditions. This study aims to see if improving attention, executive function, memory, and emotional regulation through GOALS can enhance daily life and cognitive performance. It also uses advanced MRI to explore changes in brain structure and function linked to these improvements. The study randomly assigns 36 Veterans with chronic mTBI to either the GOALS training or treatment as usual (TAU) for 5 weeks. GOALS is a therapist-led program focusing on mindfulness-based attention regulation and goal management applied to real-life activities. Additionally, 15 healthy Veterans without TBI will participate as a control group, undergoing neuropsychological testing and MRI but no intervention. Participants will be assessed at baseline, after 5 weeks, and at 6 months using brain imaging (3T and 7T MRI, diffusion tensor imaging, resting state fMRI), neuropsychological tests for attention and executive function, real-life task performance, and self-reports on daily functioning and emotional health. The study will monitor cognitive and brain changes over time to understand the lasting effects of GOALS training on Veterans with mTBI.
CONDITIONS
Brief Title
Mild TBI Assessment & Rehabilitation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Ages 18 or older
- History of mild traumatic brain injury confirmed by medical records and assessment
- Chronic, stable recovery phase at least 6 months after last concussion
- Report of moderate or severe cognitive symptoms interfering with daily life
- Able and willing to participate in training and assessments
- Stable psychoactive medication use if applicable (at least 30 days)
- For healthy control group: no history of any traumatic brain injury
- Willingness to participate in assessments
You will not qualify if you...
- History of moderate or severe traumatic brain injury
- Unstable medical, neurological, or psychiatric conditions including severe cognitive dysfunction
- Contraindications to MRI
- Ongoing illicit drug or alcohol abuse (AUDIT score over 8)
- Psychosis
- Severe depression, anxiety, or PTSD preventing participation
- Poor comprehension of English
- For healthy controls: any history of traumatic brain injury
- Other unstable neuropsychiatric disorders excluding stable depression or PTSD
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 5 weeks
Participants with mild traumatic brain injury undergo 5 weeks of cognitive training (GOALS) or receive standard clinical care, involving application of mindfulness-based attention regulation and goal management strategies or brain health education.
Weekly visits during the 5-week training period
Monitoring
Duration - 6 months post-treatment
Participants undergo neuropsychological assessments and MRI scans at baseline, week 5, and 6 months to evaluate cognitive function and brain changes following training or standard care.
3 visits (baseline, week 5, 6 months follow-up)
Trial Site Locations
Total: 2 locations
1
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121-1563
Completed
2
University of California, San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
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Research Team
P
Pratik Mukherjee, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Resting-State Connectivity Changes After Goal-Oriented Attentional Self-Regulation Training in Veterans With Mild Traumatic Brain Injury: Preliminary Findings from a Randomized Controlled Trial.
Maria Kryza-Lacombe, Rachel Santiago, Anna Hwang...
https://pubmed.ncbi.nlm.nih.gov/37405257Goal-Oriented Attentional Self-Regulation Training in Chronic Mild Traumatic Brain Injury is Linked to Microstructural Plasticity in Prefrontal White Matter.
Haleh Karbasforoushan, Jamie Wren-Jarvis, Anna Hwang...
https://pubmed.ncbi.nlm.nih.gov/39470361Goal-Oriented Attention Self-Regulation Training Improves Executive Functioning in Veterans with Post-Traumatic Stress Disorder and Mild Traumatic Brain Injury.
Tatjana Novakovic-Agopian, Lainie Posecion, Erica Kornblith...
https://pubmed.ncbi.nlm.nih.gov/33019861Goal-Oriented Attentional Self-Regulation Training Improves Executive Function and Complex Attention in Veterans With mTBI-Randomized-Control Study.
Rachel Santiago, Maria Kryza-Lacombe, Jillian Tessier...
https://pubmed.ncbi.nlm.nih.gov/41838854