Combined Metacognitive Training for mTBI/PTSD

Overseen By Yi Zhang, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Seizure meds, Antidepressants

Disqualifiers: Learning disability, Neurological disease, Alcohol abuse, others

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

Compensation: Varies

Number of Visits: 14

Duration: 10 weeks

63 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining Goal Management Training with Attention Training can help veterans with mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) improve cognitive skills, such as problem-solving and attention. Participants will receive training either in-person or through telehealth sessions. The study will compare these methods to a Brain Health Workshop to identify the most effective approach. Veterans diagnosed with both mTBI and PTSD who have experienced attention issues might be suitable candidates for this trial. As an unphased trial, it offers veterans a unique opportunity to explore innovative approaches to enhancing cognitive skills.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have recently changed medications for seizures, depression, or memory. It's best to discuss your specific situation with the trial coordinators.

What prior data suggests that this combined training is safe for Veterans with mTBI/PTSD?

Earlier studies have shown promise in combining Goal Management Training with Attention Training. This training aids individuals with brain injuries by enhancing their focus on tasks and problem-solving abilities. So far, studies have not reported any major safety concerns, and participants generally tolerate these sessions well.

Participants engage in group sessions and one-on-one attention exercises. These activities aim to improve focus and decision-making skills and can be conducted in person or through online telehealth services. Both methods have effectively boosted cognitive skills without causing harm.

While specific data on side effects from these studies is lacking, the emphasis on mental exercises suggests a lower risk of physical side effects compared to some medications. Overall, the available evidence indicates a safe experience for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Combined Metacognitive Training for mTBI/PTSD because it offers a novel approach to cognitive rehabilitation. Unlike traditional therapies that may focus solely on symptom management, this treatment aims to improve cognitive functioning directly by enhancing metacognitive skills, which can help patients better manage and execute complex tasks. The inclusion of both in-person and telehealth options makes it highly accessible, accommodating various patient needs and preferences. Additionally, the structured goal management and attention training provide a comprehensive strategy that can be more engaging and tailored compared to standard educational sessions. This multifaceted approach holds promise for more effective and personalized care for individuals dealing with mTBI and PTSD.

What evidence suggests that this trial's treatments could be effective for mTBI/PTSD?

This trial will compare different methods of delivering Goal Management Training combined with Attention Training for Veterans with mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD). Research has shown that combining Goal Management Training with Attention Training may improve problem-solving, focus, and everyday tasks. This treatment teaches strategies to better manage complex tasks and enhance attention. Although it doesn't fully restore thinking skills to normal, it has effectively boosted some mental abilities, such as planning and organizing. These early results offer promise for those seeking to overcome cognitive challenges linked to mTBI and PTSD. ^{1 6 7 8 9}

Who Is on the Research Team?

Julia K. Waid-Ebbs, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for Veterans who served in OIF-OEF-OND, diagnosed with mild traumatic brain injury (mTBI) and PTSD at least 6 months ago. They must have attention deficits, access to a computer or smartphone with internet, and a friend or family member willing to fill out a questionnaire. Excluded are those with learning disabilities, ongoing litigation related to their injury, recent medication changes for seizures/depression/memory, other cognitive therapy participation, non-fluent English speakers, severe psychiatric history leading to hospitalization.

Inclusion Criteria

My last mild brain injury was over 6 months ago.

I have someone who can fill out a questionnaire for me.

Access to a home computer, or smartphone with internet access.

Exclusion Criteria

I understand the study's expectations and risks and can consent.

I have been hospitalized for a psychiatric condition.

Reported involvement in current litigation related to injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Goal Management Training plus Attention Training either in-person or via telehealth for 10 weeks

10 weeks

10 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

4 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Goal Management Training plus Attention Training

Trial Overview The study tests Goal Management Training combined with Attention Training against Brain Health Workshops and National Geographic Movies in improving cognition for Veterans with mTBI/PTSD. It will compare the effectiveness of these treatments delivered both in-person and via telehealth on executive function and real-life tasks.

How Is the Trial Designed?

Group I: Telehealth GMT plus Attention Training Experimental Treatment 1 Intervention

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

Group II: Inpatient GMT plus Attention Training Experimental Treatment 1 Intervention

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.

Group III: Brain Health Workshop Placebo Group 1 Intervention

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.

Goal Management Training plus Attention Training is already approved in United States for the following indications:

Approved in United States as GMT plus Attention Training for:

• Improvement in executive function and attention in Veterans with mTBI/PTSD

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

In a study involving 123 Iraq/Afghanistan War veterans with mild traumatic brain injury, older age and poorer attention performance at baseline were linked to higher attendance rates in a 10-week Compensatory Cognitive Training (CCT) program.

These findings suggest that targeting neuropsychological factors, such as attention, could enhance adherence to cognitive interventions like CCT, potentially improving outcomes for veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Intervention Adherence in Compensatory Cognitive Training for Veterans With a History of Mild Traumatic Brain Injury. Mahmood, Z., Clark, JMR., Jak, AJ., et al.[2021]

In a study involving 71 adults with traumatic brain injury, the combination of Memory and Attention Adaptation Training (MAAT) with methylphenidate (MPH) showed significant improvements in cognitive functions such as word-list learning and nonverbal learning compared to other treatment combinations.

The results indicate that MAAT, especially when paired with MPH, is effective in enhancing attention, episodic memory, and executive functioning in individuals experiencing persistent cognitive issues after TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methylphenidate and Memory and Attention Adaptation Training for Persistent Cognitive Symptoms after Traumatic Brain Injury: A Randomized, Placebo-Controlled Trial. McDonald, BC., Flashman, LA., Arciniegas, DB., et al.[2018]

Veterans with both mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD) showed significantly slower and more variable attentional responses compared to those with PTSD only and a control group, indicating greater attentional deficits.

The study revealed that these veterans had particular difficulty orienting visual attention to stimuli in the left visual field, suggesting a potential right hemisphere deficit in attentional processing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mild traumatic brain injury and posttraumatic stress disorder: investigation of visual attention in Operation Iraqi Freedom/Operation Enduring Freedom veterans. Barlow-Ogden, K., Poynter, W.[2019]

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]

Goal Management Training (GMT) combined with the Veterans Task Manager (VTM) significantly improved executive cognitive functions and life role participation in 14 veterans with chronic mild traumatic brain injury and post-traumatic stress disorder, as evidenced by statistically significant improvements in various cognitive and participation measures.

The study highlights the importance of individualized treatment approaches, as participants showed varying responses to GMT, suggesting that precision neurorehabilitation could enhance outcomes for those with mTBI/PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Executive function improvement in response to meta-cognitive training in chronic mTBI / PTSD. Waid-Ebbs, JK., Wen, PS., Grimes, T., et al.[2023]

The GOALS cognitive rehabilitation program, which combines mindfulness and goal management strategies, was associated with significant improvements in attention and executive functioning in 33 Veterans with PTSD and mild TBI.

Improvements in cognitive control processes after GOALS training were linked to reductions in hyperarousal symptoms of PTSD, suggesting that enhancing cognitive skills can also positively impact emotional distress in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in executive functioning after Goal-Oriented Attentional Self-Regulation training is associated with reduction in PTSD hyperarousal symptoms among veterans with comorbid PTSD and mild TBI. Maruyama, BA., Abrams, G., Kornblith, E., et al.[2023]

A randomized controlled trial with 124 adults showed that both a 9-hour cognitive training program (SMART) and a psychoeducational control group (Brain Health Workshop) led to significant improvements in neurocognitive functioning, including memory and executive functioning, in individuals with mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD).

Over 60% of participants in both groups experienced clinically significant improvements, suggesting that even psychoeducation alone can be effective, and indicating that a longer duration of the SMART training may be necessary to achieve greater benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Training for Mild Traumatic Brain Injury and Posttraumatic Stress Disorder. Samuelson, KW., Engle, K., Abadjian, L., et al.[2020]

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]

Citations

1. reporter.nih.gov reporter.nih.gov/search/10EECF0E478FC5D47598B8961CAA4A01A2FFCEB861BF/project-details/10977066

Comparing the effectiveness of telehealth to in ... - NIH RePORTER ... Goal Management Training plus computerized attention training in Veterans with mTBI/PTSD. Preliminary testing suggests an effectiveness in improving problem ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04044456

Study Details | NCT04044456 | Combining Attention and ... This project will innovatively combine a strategy training called Goal Management Training with computerized attention training to improve tests of problem ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05380050?locStr=United+States&country=United+States&aggFilters=status%3A

Study Details | NCT05380050 | Comparing Telehealth to In ... This study will evaluate an innovatively combined strategy training known as Goal Management Training plus computerized attention training in Veterans with mTBI ...

4. reporter.nih.gov reporter.nih.gov/search/_KHTVkv4XUGS-OL7AjfdOg/project-details/10977066

Comparing the effectiveness of telehealth to in ... - NIH RePORTER ... Goal Management Training plus computerized attention training in Veterans with mTBI/PTSD. Preliminary testing suggests an effectiveness in improving problem ...

5. clinicaltrial.be clinicaltrial.be/en/details/17039?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Comparing Telehealth to In-person a Combined ... Collectively, the data have shown that GMT improved some aspects of executive function in mTBI/PTSD but did not restore cognition to normal ...

6. trialstoday.org trialstoday.org/list/print/NCT05380050

Comparing Telehealth to In-person a Combined ... This study will evaluate an innovatively combined strategy training known as Goal Management Training plus computerized attention training in ...

7. withpower.com withpower.com/trial/phase-injuries-brain-10-2022-5b039

Combined Metacognitive Training for mTBI/PTSD This trial will test a new treatment combining goal management and computer-based attention training for Veterans with mild brain injuries and PTSD.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7726225/

Cognitive Training for Mild Traumatic Brain Injury and ... The typical SMART training consists of 15 h of training conducted over 10 group sessions in the first 5 weeks and a final 3 h of training at spaced intervals ...

9. sciencedirect.com sciencedirect.com/topics/psychology/goal-management-training

Goal Management Training - an overview The primary objective of GMT is training individuals with brain injury to stop ongoing activity in order to construct goal hierarchies and actively monitor and ...