GOALS Training + Brain Health Education for Traumatic Brain Injury

(MTAR Trial)

Not currently recruiting at 1 trial location

Overseen By Tatjana Novakovic-Agopian, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Moderate/severe TBI, Psychosis, Severe depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special cognitive training program can help Veterans with mild traumatic brain injury (TBI) improve their attention and daily life. The study compares Goal-Oriented Attentional Self-Regulation (GOALS) Training with regular treatment to determine which is more effective. It also examines whether these improvements relate to changes in brain function. Veterans who have had mild TBI for over six months and experience cognitive issues affecting daily life might be suitable candidates for this trial. As an unphased trial, it offers Veterans the opportunity to contribute to innovative research that could enhance cognitive rehabilitation strategies.

Will I have to stop taking my current medications?

If you are on psychoactive medications, you must be stable on them for more than 30 days to participate in the trial. This means you can continue taking your current medications as long as they have been stable for that period.

What prior data suggests that these interventions are safe for Veterans with mild TBI?

Studies have shown that Goal-Oriented Attentional Self-Regulation (GOALS) training is generally well-tolerated by participants. Research indicates that this method can improve focus and thinking skills in individuals with long-term traumatic brain injury (TBI). Specifically, one study involving 32 Veterans with chronic TBI demonstrated improvements both shortly after the training and up to two years later. Participants reported no major negative effects, suggesting it is safe. This makes GOALS a promising option for enhancing mental abilities after a brain injury. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GOALS Training + Brain Health Education approach for traumatic brain injury (TBI) because it offers a fresh take on cognitive rehabilitation. Unlike standard treatments that often focus on medication or passive therapy, GOALS uses Goal-Oriented Attentional Self-Regulation, a technique that actively engages patients in their own recovery by helping them improve their attention and self-regulation skills. This method could empower individuals with TBI to better manage their symptoms and enhance their quality of life by targeting cognitive functions directly. By focusing on self-regulation, GOALS aims to offer a more personalized and proactive path to recovery compared to traditional treatments.

What evidence suggests that this trial's treatments could be effective for mild TBI?

Studies have shown that Goal-Oriented Attentional Self-Regulation (GOALS) training can help individuals with long-term traumatic brain injury (TBI) enhance their attention, task management, and decision-making abilities. In past research, participants with long-term brain injuries experienced significant improvements after using GOALS, particularly in focus and task planning and organization. In this trial, veterans with mild TBI will undergo GOALS cognitive training as an intervention. These results suggest that GOALS training could be a promising method to help veterans with mild TBI better manage their cognitive and planning challenges. ^{1 6 7 8 9}

Who Is on the Research Team?

Pratik Mukherjee, MD PhD

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Are You a Good Fit for This Trial?

This trial is for Veterans aged 18+ with mild TBI who've been stable post-concussion for over 6 months and can commit to training and assessments. It's also open to healthy Veterans without TBI history, able to participate in assessments. Excluded are those with severe mental health issues, poor English skills, ongoing substance abuse, or conditions preventing study participation.

Inclusion Criteria

For the TBI-negative healthy veteran control group: Able and willing to commit to participate in assessments

For TBI-positive veteran participants to be randomized to either GOALS or TAU: Able and willing to commit to participate in training and assessments

I am a veteran over 18 with a TBI.

Exclusion Criteria

For the TBI-negative healthy veteran control group: Severe depression, anxiety or PTSD that precludes participation in research activities

I am a veteran with stable mental health conditions like depression or PTSD.

For TBI-positive veteran participants to be randomized to either GOALS or TAU: Unstable medical, neurologic, or psychiatric condition, including severe cognitive dysfunction, or other reasons for being unable or unwilling to participate in study procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 5 weeks of cognitive training (GOALS) or treatment as usual (TAU) comparison

5 weeks

Baseline, week 5 (post GOALS)

Follow-up

Participants are monitored for changes in neurocognitive function and brain networks at 6 months post-training

6 months

6 months post-training

Long-term Follow-up

Participants are assessed for maintenance of changes in behavioral function and imaging measures

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Brain Health Education (BHE)
• fMRI
• Goal-Oriented Attentional Self-Regulation (GOALS)

Trial Overview The trial tests if Goal-Oriented Attentional Self-Regulation (GOALS) improves daily life functioning in Veterans with mild TBI compared to standard Brain Health Education (BHE). The effectiveness will be measured through cognitive/behavioral performance changes and fMRI scans of brain networks.

How Is the Trial Designed?

Group I: Veteran Mild TBI Group - GOALS Intervention Experimental Treatment 2 Interventions

Veterans ages 18+ with chronic mild TBI, to undergo GOALS cognitive training as an intervention.

Group II: Veteran Mild TBI - Treatment as Usual Active Control 2 Interventions

Veterans ages 18+ with chronic mild TBI, matched by demographic and clinical criteria to the GOALS group, to receive the standard clinical care.

Group III: Veteran Non TBI - No Treatment Active Control 1 Intervention

Veterans ages 18+ with no history of TBI, to undergo Neuropsychologic evaluation and MR Imaging with no intervention.

Goal-Oriented Attentional Self-Regulation (GOALS) is already approved in United States for the following indications:

Approved in United States as GOALS Training for:

• Cognitive rehabilitation for mild traumatic brain injury (mTBI)
• Improvement of executive functioning in veterans with post-traumatic stress disorder (PTSD) and mTBI

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

The COMPASS(goal) program aims to improve community reintegration for veterans with mild traumatic brain injury by focusing on goal-setting and self-management skills, with a planned recruitment of 110 participants over three years.

By using a structured intervention that includes eight weekly sessions, the program seeks to enhance executive function and independence in veterans, addressing cognitive deficits that hinder their ability to set and achieve personal goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Executive functioning in TBI from rehabilitation to social reintegration: COMPASS (goal,) a randomized controlled trial (grant: 1I01RX000637-01A3 by the VA ORD RR&D, 2013-2016). Libin, AV., Scholten, J., Schladen, MM., et al.[2023]

Cognitive rehabilitation training using Goal-Oriented Attentional Self-Regulation (GOALS) significantly improved executive function and complex task performance in 33 veterans with chronic traumatic brain injury (TBI) after 5 weeks of training, compared to a control group receiving Brain-Health Education.

Participants who underwent GOALS training also reported better emotional regulation, indicating that this type of training can enhance both cognitive and emotional functioning in veterans with TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training in Goal-Oriented Attention Self-Regulation Improves Executive Functioning in Veterans with Chronic Traumatic Brain Injury. Novakovic-Agopian, T., Kornblith, E., Abrams, G., et al.[2021]

Both Goal Management Training and Identity Oriented Goal Training were well-received by participants with traumatic brain injury, leading to improved mood and goal attainment over a 6-8 week period.

Identity Oriented Goal Training effectively engaged participants in the goal-setting process, while Goal Management Training provided a structured approach to prevent errors during goal performance, although both methods were time-intensive for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of self-regulation informed goal setting in people with traumatic brain injury. McPherson, KM., Kayes, N., Weatherall, M.[2014]

A study involving 24 Veterans with chronic traumatic brain injury (TBI) showed that long-term executive function training (GOALS) led to significant improvements in attention, functional task performance, and emotional regulation, assessed over 6+ months after training.

Participants reported a notable increase in their likelihood of engaging in competitive employment or volunteering, rising from 26% at baseline to 61% at follow-up, indicating the training's positive impact on daily functioning and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of executive function training among veterans with chronic TBI. Novakovic-Agopian, T., Kornblith, E., Abrams, G., et al.[2021]

The combination of modified Goal Management Training (mGMT) and the RehaGoal App was found to be feasible for helping individuals with executive function impairments after traumatic brain injury (TBI), with all four participants showing improvement in their self-defined goals over an 8-week intervention.

Participants reported excellent usability of the RehaGoal App, and the collected metrics data provided valuable insights into user behavior, suggesting that the app could effectively support rehabilitation efforts and may be suitable for larger studies in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guiding patients with traumatic brain injury through the instrumental activities of daily living with the RehaGoal App: a feasibility study. Ertas-Spantgar, F., Korabova, S., Gabel, A., et al.[2022]

Cognitive rehabilitation training using the GOALS program significantly improved attention and executive function in 40 military Veterans with comorbid PTSD and mild TBI, as evidenced by neuropsychological assessments and self-reported emotional regulation measures.

Participants who underwent GOALS training also reported a significant decrease in PTSD symptoms and improved performance on complex functional tasks, suggesting that enhancing cognitive control can positively impact emotional and functional outcomes for Veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goal-Oriented Attention Self-Regulation Training Improves Executive Functioning in Veterans with Post-Traumatic Stress Disorder and Mild Traumatic Brain Injury. Novakovic-Agopian, T., Posecion, L., Kornblith, E., et al.[2022]

A study involving 16 individuals with acquired brain injury showed that 94% continued to use at least one strategy learned from Goal-Oriented Attentional Self-Regulation (GOALS) training 20 months after completion, indicating the training's long-term applicability.

Seventy-five percent of participants reported improved functioning due to the training, suggesting that GOALS training can provide significant benefits for individuals with chronic executive dysfunction following brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Use and Perceived Benefits of Goal-Oriented Attentional Self-Regulation Training in Chronic Brain Injury. Loya, F., Novakovic-Agopian, T., Binder, D., et al.[2020]

Goal planning is crucial in rehabilitation for brain injury, as it helps address deficits in executive function and teaches clients to manage daily tasks beyond formal therapy.

The article proposes interventions at both the goal level and the self-regulation level, emphasizing the importance of tailored experimental methodologies to accommodate individual differences in cognitive status during research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-regulation and goal theories in brain injury rehabilitation. Hart, T., Evans, J.[2019]

Traumatic brain injury often leads to limited self-awareness, making it challenging for individuals to set realistic rehabilitation goals.

A supportive, nondirective goal-setting process involving therapists can help patients develop realistic goals that enhance their self-awareness and improve the chances of maintaining progress after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awareness and goal setting with the traumatically brain injured. Bergquist, TF., Jacket, MP.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8104023/

Training in Goal-Oriented Attention Self-Regulation ... In a prior study, participants with chronic acquired brain injury significantly improved after training in Goal-Oriented Attentional Self-Regulation (GOALS) on ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39470361/

Goal-Oriented Attentional Self-Regulation Training in ... GOALS training has been demonstrated to improve attention and executive functioning in patients with chronic TBI.

3. medrxiv.org medrxiv.org/content/10.1101/2023.09.29.23296363v1.full-text

Goal-Oriented Attentional Self-Regulation Training in ... GOALS training has been demonstrated to improve attention and executive functioning in patients with chronic TBI. However, its impact on ...

4. journals.sagepub.com journals.sagepub.com/doi/abs/10.1089/neu.2023.0229

Goal-Oriented Attentional Self-Regulation Training in ... GOALS training has been demonstrated to improve attention and executive functioning in patients with chronic TBI. However, its impact on microstructural ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07190365

Goal-oriented Telehealth Rehabilitation of Executive ... The Goal-Oriented Attentional Self-regulation training involves ten 2-hour sessions of group-based telehealth training, three individual 1-hour ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02920788

Study Details | NCT02920788 | Mild TBI Assessment & ... Preliminary data from recently completed randomized-control GOALS study in 32 Veterans with chronic TBI also show both short and longer term (up to 2 years) ...

7. researchgate.net researchgate.net/publication/324903249_Training_in_Goal-Oriented_Attentional_Self-Regulation_Improves_Executive_Functioning_in_Veterans_with_Chronic_TBI

(PDF) Training in Goal-Oriented Attentional Self ... In a prior study, participants with chronic acquired brain injury significantly improved after training in goal-oriented attentional self- ...

8. liebertpub.com liebertpub.com/doi/10.1089/neur.2022.0074

Resting-State Connectivity Changes After Goal-Oriented ... Goal-Oriented Attentional Self-Regulation (GOALS) training has been shown to improve attention and executive functioning, as well as emotional ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5318616/

Long-Term Use and Perceived Benefits of Goal-Oriented ... Conclusions. GOALS training shows promising long-term benefits for individuals in the chronic phase of brain injury. Identifying individual- and injury-level ...