Combined Metacognitive Training for mTBI/PTSD
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
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.
12345Is 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.
12367How 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.
13678Eligibility 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.
+2 more
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.
+9 more
Trial 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)
Participant Groups
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.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Telehealth GMT plus Attention TrainingExperimental Treatment1 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 TrainingExperimental Treatment1 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 WorkshopPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
North Florida/South Georgia Veterans Health System, Gainesville, FLGainesville, FL
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Goal-Oriented Attention Self-Regulation Training Improves Executive Functioning in Veterans with Post-Traumatic Stress Disorder and Mild Traumatic Brain Injury. [2022]Difficulties in executive-control functions are common sequelae of both traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD). The goal of this study was to assess whether a cognitive rehabilitation training that was applied successfully in civilian and military TBI would be effective for military Veterans with comorbid PTSD and mild TBI (mTBI). In the previous study, Veterans with a history of mild to severe TBI improved significantly after goal-oriented attentional self-regulation (GOALS) training on measures of attention/executive function, functional task performance, and emotional regulation. The objective of this study was to assess effects of GOALS training in Veterans with comorbid PTSD and mTBI. Forty Veterans with a current PTSD diagnosis and history of mTBI (6+ months post) were randomized to either five weeks of GOALS or Brain-Health Education (BHE) training matched in time and intensity. Evaluator-blinded assessments at baseline and post-training included neuropsychological and complex functional task performance, and self-report measures of emotional functioning/regulation. After GOALS but not BHE training, participants significantly improved from baseline on primary outcome measures of: overall complex attention/executive function neuropsychological performance composite (F = 12.35, p = 0.001; Cohen d = 0.48), and overall mood disturbance -POMS emotional regulation self-report (F = 4.29, p = 0.05, Cohen d = 0.41). In addition, GOALS but not BHE participants indicated a significant decrease in PTSD symptoms (PCL-M Total Score) (F = 4.80, p = 0.05, Cohen d = 0.60), and demonstrated improvement on complex functional task performance-GPS Learning and Memory (F = 5.06, p = 0.05, Cohen d = 0.56]. Training in attentional self-regulation applied to participant-defined goals may improve cognitive functioning in Veterans with comorbid PTSD and mTBI. Improving cognitive control functioning may also improve functioning in other domains such as emotional regulation and functional performance, potentially making it particularly relevant for Veterans with a history of mTBI and comorbid psychiatric symptoms.
Executive function improvement in response to meta-cognitive training in chronic mTBI / PTSD. [2023]We tested Goal Management Training (GMT), which has been recommended as an executive training protocol that may improve the deficits in the complex tasks inherent in life role participation experienced by those with chronic mild traumatic brain injury and post-traumatic stress disease (mTBI/PTSD). We assessed, not only cognitive function, but also life role participation (quality of life).
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]Goal-Oriented Attentional Self-Regulation (GOALS) is a cognitive rehabilitation training program that combines mindfulness-based attention regulation with individualized goal management strategies to improve functioning in daily life after traumatic brain injury (TBI). While not a specific target of GOALS training, previous research has indicated improvements in emotional functioning following GOALS training, specifically symptoms related to depression and posttraumatic stress disorder (PTSD). The current study is based on the hypothesis that improvements in cognitive control processes related to executive functioning and attention after GOALS training generalize to improvements in emotional functioning, thereby resulting in reductions in emotional distress. The current study analyzed archival data from 33 Veteran participants with a confirmed diagnosis of PTSD and a history of mild TBI who received either GOALS training or a psychoeducational intervention matched for time, therapist attention, and participation format. Regression analysis was used to assess the strength of the relationship between improvements in Overall Attention/Executive Functioning and decreases in hyperarousal symptoms associated with PTSD. Results from the regression analysis revealed that improvements in Overall Attention/Executive Functioning after GOALS was significantly associated with reductions in hyperarousal symptoms associated with PTSD (R2 = 0.26, F(1,15) = 5.01, β = -.51, p < .05). The current findings suggest that cognitive improvements after GOALS training may lead to changes in emotional functioning, resulting in decreased emotional distress. This is important, particularly in VA settings, because the results potentially highlight additional areas of research and focus on the treatment of comorbid mild TBI and PTSD among Veterans.
Predictors of Intervention Adherence in Compensatory Cognitive Training for Veterans With a History of Mild Traumatic Brain Injury. [2021]The purpose of this study was to determine modifiable predictors of intervention adherence in a study of group-based Compensatory Cognitive Training (CCT) for Iraq/Afghanistan War veterans with a history of mild traumatic brain injury (mTBI).
Methylphenidate and Memory and Attention Adaptation Training for Persistent Cognitive Symptoms after Traumatic Brain Injury: A Randomized, Placebo-Controlled Trial. [2018]The purpose of this multicenter, prospective, randomized, placebo-controlled study was to evaluate and compare the efficacy of two cognitive rehabilitation interventions (Memory and Attention Adaptation Training (MAAT) and Attention Builders Training (ABT)), with and without pharmacological enhancement (ie, with methylphenidate (MPH) or placebo), for treating persistent cognitive problems after traumatic brain injury (TBI). Adults with a history of TBI at least 4 months before study enrollment with either objective cognitive deficits or subjective cognitive complaints were randomized to receive MPH or placebo and MAAT or ABT, yielding four treatment combinations: MAAT/MPH (N=17), ABT/MPH (N=19), MAAT/placebo (N=17), and ABT/placebo (N=18). Assessments were conducted pre-treatment (baseline) and after 6 weeks of treatment (post treatment). Outcome measures included scores on neuropsychological measures and subjective rating scales. Statistical analyses used linear regression models to predict post-treatment scores for each outcome variable by treatment type, adjusting for relevant covariates. Statistically significant (PABT/placebo), nonverbal learning (MAAT/MPH>MAAT/placebo and MAAT/MPH>ABT/MPH), and auditory working memory and divided attention (MAAT/MPH>ABT/MPH). These results suggest that combined treatment with metacognitive rehabilitation (MAAT) and pharmacotherapy (MPH) can improve aspects of attention, episodic and working memory, and executive functioning after TBI.
Mild traumatic brain injury and posttraumatic stress disorder: investigation of visual attention in Operation Iraqi Freedom/Operation Enduring Freedom veterans. [2019]Mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD) are prevalent dual impairments in veterans returning from the wars in Iraq and Afghanistan. Attention problems are a common self-reported complaint of veterans with mTBI, but relatively few studies have investigated the types and levels of behavioral attentional deficits present in veterans with mTBI and PTSD. The purpose of this study was to compare visual attentional performance between samples of veterans with both mTBI and PTSD (mTBI+PTSD), PTSD only, and a control group. Overall, the attentional responses of the mTBI+PTSD group were slower than those of the PTSD and control groups. The response times were also more variable, suggesting difficulty with attentional vigilance. Additionally, we found evidence of hemispheric asymmetries in attentional performance. Participants with mTBI+PTSD were less efficient in orienting visual attention to stimuli flashed to the left visual field (LVF), suggesting a right hemisphere deficit. Overall, we found that veterans who had sustained an mTBI and had a coexisting PTSD diagnosis displayed longer response times and were less accurate than the PTSD and control groups, especially when cues were presented to the LVF.
Training in Goal-Oriented Attention Self-Regulation Improves Executive Functioning in Veterans with Chronic Traumatic Brain Injury. [2021]Deficits in executive control functions are some of the most common and disabling consequences of both military and civilian brain injury. However, effective interventions are scant. The goal of this study was to assess whether cognitive rehabilitation training that was successfully applied in chronic civilian brain injury would be effective for military veterans with traumatic brain injury (TBI). In a prior study, participants with chronic acquired brain injury significantly improved after training in Goal-Oriented Attentional Self-Regulation (GOALS) on measures of attention/executive function, functional task performance, and goal-directed control over neural processing on functional magnetic resonance imaging. The objective of this study was to assess effects of GOALS training in veterans with chronic TBI. A total of 33 veterans with chronic TBI and executive difficulties in their daily life completed either 5 weeks of manualized GOALS training or Brain-Health Education (BHE) matched by time and intensity. Evaluator-blinded assessments at baseline and post-training included neuropsychological and complex functional task performance and self-report measures of emotional regulation. After GOALS, but not BHE training, participants significantly improved from baseline on primary outcome measures of Overall Complex Attention/Executive Function composite neuropsychological performance score (F = 7.10, p = 0.01; partial η2 = 0.19), and on overall complex functional task performance (Goal Processing Scale Overall Performance; F = 6.92, p = 0.01, partial η2 = 0.20). Additionally, post-GOALS participants indicated significant improvement on emotional regulation self-report measures (Profile of Mood States Confusion Score; F = 6.05, p = 0.02, partialη2 = 0.20). Training in attentional self-regulation applied to participant-defined goals may improve cognitive functioning in veterans with chronic TBI. Attention regulation training may not only impact executive control functioning in real-world complex tasks, but also may improve emotional regulation and functioning. Implications for treatment of veterans with TBI are discussed.
Cognitive Training for Mild Traumatic Brain Injury and Posttraumatic Stress Disorder. [2020]Although there is evidence of mild cognitive impairments for many individuals with mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD), little research evaluating the effectiveness of cognitive training interventions has been conducted. This randomized controlled trial examined the effectiveness of a 9-h group cognitive training targeting higher-order functions, Strategic Memory Advanced Reasoning Training (SMART), compared to a 9-h psychoeducational control group in improving neurocognitive functioning in adults with mTBI and PTSD. A sample of 124 adults with histories of mild TBI (n = 117) and/or current diagnoses of PTSD (n = 84) were randomized into SMART (n = 66) or Brain Health Workshop (BHW; n = 58) and assessed at three time points: baseline, following training, and 6 months later. Participants completed a battery of neurocognitive tests, including a test of gist reasoning (a function directly targeted by SMART) as well as tests of verbal, visual, and working memory and executive functioning, functions commonly found to be mildly impaired in mTBI and PTSD. The two groups were compared on trajectories of change over time using linear mixed-effects models with restricted maximum likelihood (LMM). Contrary to our hypothesis that SMART would result in superior improvements compared to BHW, both groups displayed statistically and clinically significant improvements on measures of memory, executive functioning, and gist reasoning. Over 60% of the sample showed clinically significant improvements, indicating that gains can be found through psychoeducation alone. A longer SMART protocol may be warranted for clinical samples in order to observe gains over the comparison group.