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

Trial Summary

What is the purpose of this trial?

This trial will test a new treatment combining goal management and computer-based attention training for Veterans with mild brain injuries and PTSD. The goal is to improve their focus, problem-solving skills, and daily functioning. The study will compare in-person and telehealth delivery methods. Goal Management Training (GMT) has been previously tested for improving cognitive functioning in individuals with PTSD.

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 data supports the effectiveness of the treatment Goal Management Training plus Attention Training for mTBI/PTSD?

Research shows that Goal Management Training (GMT) and similar cognitive rehabilitation programs like Goal-Oriented Attentional Self-Regulation (GOALS) can improve attention, executive function, and emotional regulation in veterans with mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD). These improvements are associated with reduced PTSD symptoms and better daily functioning. ^{1 2 3 4 5}

Is the Combined Metacognitive Training for mTBI/PTSD safe for humans?

The studies on Goal-Oriented Attentional Self-Regulation (GOALS) training, which is similar to the Combined Metacognitive Training, show improvements in cognitive and emotional functioning without reporting any safety concerns, suggesting it is generally safe for humans. ^{1 2 3 6 7}

How is the Combined Metacognitive Training for mTBI/PTSD treatment different from other treatments?

This treatment is unique because it combines Goal Management Training with Attention Training, focusing on improving cognitive control and emotional regulation by helping patients manage their attention and goals, which is particularly beneficial for veterans with mild traumatic brain injury and PTSD. ^{1 3 6 7 8}

Research Team

Julia K. Waid-Ebbs, PhD

Principal Investigator

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

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. 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]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Executive function improvement in response to meta-cognitive training in chronic mTBI / PTSD. [2023]

3. United States 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. [2023]

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

Predictors of Intervention Adherence in Compensatory Cognitive Training for Veterans With a History of Mild Traumatic Brain Injury. [2021]

5. England 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. [2018]

6. United States 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. [2019]

7. 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]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive Training for Mild Traumatic Brain Injury and Posttraumatic Stress Disorder. [2020]