GOALS Training + Brain Health Education for Traumatic Brain Injury

(MTAR Trial)

Overseen by Pratik Mukherjee, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

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

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

One of the most pressing concerns within the VA currently is the provision of interventions that address the cognitive as well as emotional problems faced by Veterans with mild TBI and comorbid conditions. When completed, these studies will inform us whether training core attentional self-regulatory control functions via personally-relevant activities will be effective in improving daily life for Veterans with mild TBI and comorbid conditions. The study design will provide a test not only of potential benefits for real life functioning, but also determine to what extent these benefits are related to actual changes in cognitive/behavioral performance and brain networks corresponding to these functions. This project will provide a foundation for future studies to investigate the neural mechanisms that support improvements of cognition and behavior in mTBI.

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 data supports the effectiveness of the treatment GOALS Training + Brain Health Education for Traumatic Brain Injury?

Research shows that Goal-Oriented Attentional Self-Regulation (GOALS) training can improve attention, executive function, and emotional regulation in veterans with chronic traumatic brain injury. Participants in GOALS training reported long-term benefits and continued use of strategies learned, indicating its potential effectiveness in managing brain injury symptoms. ^{1 2 3 4 5}

Is GOALS Training + Brain Health Education safe for humans?

The studies on GOALS Training and Brain Health Education for traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD) in veterans did not report any safety concerns, suggesting that these interventions are generally safe for humans. ^{1 2 6 7 8}

How is the GOALS treatment different from other treatments for traumatic brain injury?

The GOALS treatment is unique because it focuses on training individuals to regulate their attention and set personal goals, which helps improve cognitive functions like attention and executive control, as well as emotional regulation. Unlike other treatments, it emphasizes self-awareness and goal-setting, which can lead to long-term improvements in daily functioning and emotional well-being. ^{1 2 3 8 9}

Research Team

Pratik Mukherjee, MD PhD

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Brain Health Education (BHE) (Other)
• fMRI (Procedure)
• Goal-Oriented Attentional Self-Regulation (GOALS) (Behavioral Intervention)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Awareness and goal setting with the traumatically brain injured. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Training in Goal-Oriented Attention Self-Regulation Improves Executive Functioning in Veterans with Chronic Traumatic Brain Injury. [2021]

3. England pubmed.ncbi.nlm.nih.gov

A pilot study of self-regulation informed goal setting in people with traumatic brain injury. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Long-Term Use and Perceived Benefits of Goal-Oriented Attentional Self-Regulation Training in Chronic Brain Injury. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Self-regulation and goal theories in brain injury rehabilitation. [2019]

6. England 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). [2023]

7. England 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. [2022]

8. United States 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Long-term effects of executive function training among veterans with chronic TBI. [2021]