Brain InjuryNCT05380050
Comparing Telehealth to In-person a Combined Metacognitive Training in Veterans With mTBI/PTSD
A study testing Goal Management Training plus Attention Training and Brain Health Workshop and National Geographic Movies in people with Brain Injury and Cognition, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Veterans with mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) commonly experience cognitive impairments including attention and executive function deficits that interfere with their ability to engage in productive personal and social activities. Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Brain Injury, Cognition, PTSD
- What is being tested?
- Goal Management Training plus Attention Training and Brain Health Workshop and National Geographic Movies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Veterans who have served in OIF-OEF-OND and have been diagnosed with both a mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) based on the joint criteria of the Veterans' Affairs and Department of Defense (VA \& DoD)
- Latest mTBI occurred at least 6 months prior to study enrollment
- Attention deficit of 1.5 SD below the mean of the RBANS attention index
- Family member or friend that is willing to complete a questionnaire
- Access to a home computer, or smartphone with internet access
Who cannot join
- History of pre-morbid learning disability
- History of psychiatric diagnosis sufficiently severe to have resulted in inpatient hospitalization
- Neurological disease unrelated to TBI (seizure disorder, stroke)
- Score < 90 on National Adult Reading Test (NART)
- Failure of validity testing on the Test of Memory Malingering (TOMM)
- Reported alcohol or substance abuse within the past year
Show all 12Show fewer
- Reported involvement in current litigation related to injury
- Recent change of medications for seizures, depression, or memory
- Currently enrolled in other cognitive therapy that cannot be discontinued
- Does not speak English fluently
- Not competent to provide consent (also, not able to demonstrate understanding of expectations of study and potential risks of participation).
- Uncontrolled, acute medical or psychiatric condition as indicated by the participant or observed by the research team member that would make it unsafe to participate in the research activities, i.e. precautions for active homicidal/suicidal intent, active psychosis, or acute symptoms requiring immediate medical attention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608-1135
Julia K Waid-Ebbs, PhD, (352) 376-1611, Julia.Waid-Ebbs@va.gov
Julia K. Waid-Ebbs, PhD
About this study
Official title: Comparing the Effectiveness of Telehealth to In-person Delivery of a Combined Metacognitive and Attention Training in Veterans With mTBI/PTSD
Veterans with mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) commonly experience cognitive impairments including attention and executive function deficits that interfere with their ability to engage in productive personal and social activities. Of the limited interventions available to address cognition, none rigorously train attention beyond strategy management. This study will evaluate an innovatively combined strategy training known as Goal Management Training plus computerized attention training in Veterans with mTBI/PTSD. Preliminary testing suggests an effectiveness in improving problem solving, attention and functional tasks in a small number of Veterans. Considering these promising results, cost effectiveness, and the demand for access to care from Veterans living in rural areas, a Randomized Controlled Trial will determine and compare the effects of this treatment, administered either in-person or via telehealth, on executive function, attention, other aspects of cognition and real life functional tasks.
Read the detailed description
Background. Over 70% of Veterans with mild traumatic brain injury (mTBI), seeking services at the Veterans' Health Administration, suffer from comorbid post-traumatic stress disorder (PTSD). These Veterans commonly experience concomitant executive dysfunction in goal setting, concentration, and attention that impairs their performance in complex daily tasks. Others and the investigators have studied Goal Management Training (GMT) to address this problem. Collectively, the data have shown that GMT improved some aspects of executive function in mTBI/PTSD but did not restore cognition to normal during complex tasks. Goal management for performing complex tasks requires cognitive processes such as attention, and direct-attention training may be beneficial in improving cognition. GMT with attention training have been used in other studies, but those did not involve Veterans with either mTBI or mTBI/PTSD. The investigators recently conducted a pilot study combining GMT and direct-attention training (GMT+ATT) in Veterans with mTBI and PTSD. The investigators discovered a large treatment effect (Cohen d=2.23) in the NIH EXAMINER Executive Composite score and a significant treatment response in the NIH EXAMINER Cognitive Control subdomain and the Unstructured Task.
GMT or ATT is typically administered in-person. In-person treatment can impose problems such as limited treatment access, poor cost-effectiveness, and unexpected situations (like the COVID-19 pandemic). As an alternative method, telehealth has been used increasingly to meet the need for care in Veterans living in rural areas and during the pandemic. Telehealth delivery of cognitive interventions in Veterans with mTBI or with PTSD has shown effectiveness that is comparable to that of in-person treatment. However, GMT+ATT has not been studied in these Veterans. Therefore, the investigators have recently developed the format for telehealth delivery of GMT+ATT in Veterans with mTBI/PTSD. The preliminary data demonstrate the feasibility of this delivery platform and similar treatment outcomes as compared to in-person therapy.
Objective \& Hypotheses. The objective of this randomized controlled trial is to determine and compare the effect of in-person and telehealth delivery of GMT+ATT in Veterans with mTBI/PTSD.
Hypothesis 1a. In-person GMT+ATT will improve cognition vs. control group (Brain Health Workshop (BHW).
Hypothesis 1b. Telehealth GMT+ATT will improve cognition vs. BHW control group Hypothesis 2. Telehealth delivery of GMT+ATT will produce response comparable to in-person treatment. Primary measure. The NIH EXAMINER executive composite score will assess overall executive function with subdomains such as complex task performance requiring goal management, as well as tests underlying cognitive control such as attention and working memory. Secondary functional measures. 1) Unstructured Task and 2) Test of Grocery Shopping Skills (ToGSS), which captures naturalistic real-world function. Exploratory Objective. To study the capability of the Attention Network Task to predict treatment response to GMT+ATT.
Methods. 63 Veterans will be randomized to 10 weeks of in-person or telehealth delivery of GMT+ATT or BHW control. Outcomes will be assessed at pre-, post-, 6 month-post and 1-year post-treatment. GMT and ATT will each be provided in ten, weekly, 2-hour sessions (4hrs/week as combined).
Significance. This study uses a novel combinational treatment of GMT+ATT to restore the executive and attentional processes required for complex daily tasks in Veterans with mTBI/PTSD. This work meets a key VA RR\&D priority of providing quality care to Veterans. Positive study results may help shape clinical practice of cognitive rehabilitation in terms of treatment strategy, delivery platform, access to care, and means to predict treatment response. Such impacts will translate to significant cost-savings for the VA healthcare system and improvement in quality of life in Veterans.
- Conditions
- Brain Injury, Cognition, PTSD, Intervention
- Being tested
- Goal Management Training plus Attention Training, Brain Health Workshop and National Geographic Movies
- Medical subject headings
- Brain Injuries, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal Management Training plus Attention TrainingBehavioural
Also called GMT + ATT
GMT is a Power Point directed interactive group training to use a five point strategy to plan and execute complex tasks. Attention Training utilizes Brain HQ attention modules and individualized attention goals.
Brain Health Workshop and National Geographic MoviesBehavioural
Also called BHW and National Geographic Movies
BHW is a Power Point directed interactive training to learn about the brain and cognitive components. National Geographic Movies, participants select movies to watch with the therapists and answers questions regarding the content.
| Study group | Role | What they receive |
|---|---|---|
| Inpatient GMT plus Attention Training | Experimental | 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. Receives: Behavioral: Goal Management Training plus Attention Training |
| Telehealth GMT plus Attention Training | Experimental | 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 Receives: Behavioral: Goal Management Training plus Attention Training |
| Brain Health Workshop | Placebo comparator | 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. Receives: Behavioral: Brain Health Workshop and National Geographic Movies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Composite Executive score of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research
computerized performance measure that assess overall executive function. Composite Executive score, which is a single score that represent performance across the Dot Counting, N-back, Flanker, Continuous Performance Test, Fluency subscales, with a range of -3.0 to 3.0 with higher scores indicating better executive function.
Measured: pre-intervention, post, 6-month and 1-year follow-up
Secondary outcomes (5)
Change in the Test of Grocery Shopping Skills
Functional task that measures efficiency of shopping for 10-items in an actual grocery store. Variables include Total Time and number of redundant Aisles, with less time and redundant Aisles indicating better performance.
Measured: week 1, week 11
Change in the attention index of the Repeatable Battery for the Assessment of Neuropsychological Status
performance measure of digit span and coding to measure attention. Range is 0-100 with higher scores indicating better attention.
Measured: week 1, week 11, week 35 and week 59
Change in Attention Network Task
Experimental computer administered flanker task to measure alerting, orienting and executive control components of attention. Range is -200 to 200 with higher scores indicating more impairment.
Measured: week 1, week 11, week 35 and week 59
Change in Traumatic Brain Injury-Quality of Life, Participation Ability and Satisfaction short-form
Self-report questionnaire to measure participation, range is 59-295 with higher scores indicating better participation
Measured: week 1, week 11, week 35 and week 59
Change in the Unstructured Task of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research
Functional Task performed in the clinic that uses strategies in paper and pencil puzzles to gain the most points possible within 6 minutes. The Unstructured Task Variable has a range of 0-1,469 points with higher points indicating better performance.
Measured: week 1, week 11, week 35 and week 59
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Nov 2022
- Primary completion30 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 63 randomized to three groups: In-patient intervention, Telehealth intervention and Control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Julia K. Waid-Ebbs, PhD, Principal investigator, North Florida/South Georgia Veterans Health System, Gainesville, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380050
- Sponsor's protocol ID
- N3984-R
- Other IDs
- 5I01RX003984-04
- Status last verified
- Sep 2026
- First submitted
- 12 May 2022
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Telehealth to In-person Delivery of a Combined Metacognitive and Attention Training in Veterans With mTBI/PTSD
- ClinicalTrials.gov ID
- NCT05380050
- Acronym / sponsor ID
- N3984-R
- Conditions
- Brain Injury, Cognition, PTSD, Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Veterans with mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) commonly experience cognitive impairments including attention and executive function deficits that interfere with their ability to engage in productive personal and social activities. Of the limited interventions available to address cognition, none rigorously train attention beyond strategy management. This study will evaluate an innovatively combined strategy training known as Goal Management Training plus computerized attention training in Veterans with mTBI/PTSD. Preliminary testing suggests an effectiveness in improving problem solving, attention and functional tasks in a small number of Veterans. Considering these promising results, cost effectiveness, and the demand for access to care from Veterans living in rural areas, a Randomized Controlled Trial will determine and compare the effects of this treatment, administered either in-person or via telehealth, on executive function, attention, other aspects of cognition and real life functional tasks.
Detailed description
Background. Over 70% of Veterans with mild traumatic brain injury (mTBI), seeking services at the Veterans' Health Administration, suffer from comorbid post-traumatic stress disorder (PTSD). These Veterans commonly experience concomitant executive dysfunction in goal setting, concentration, and attention that impairs their performance in complex daily tasks. Others and the investigators have studied Goal Management Training (GMT) to address this problem. Collectively, the data have shown that GMT improved some aspects of executive function in mTBI/PTSD but did not restore cognition to normal during complex tasks. Goal management for performing complex tasks requires cognitive processes such as attention, and direct-attention training may be beneficial in improving cognition. GMT with attention training have been used in other studies, but those did not involve Veterans with either mTBI or mTBI/PTSD. The investigators recently conducted a pilot study combining GMT and direct-attention training (GMT+ATT) in Veterans with mTBI and PTSD. The investigators discovered a large treatment effect (Cohen d=2.23) in the NIH EXAMINER Executive Composite score and a significant treatment response in the NIH EXAMINER Cognitive Control subdomain and the Unstructured Task.
GMT or ATT is typically administered in-person. In-person treatment can impose problems such as limited treatment access, poor cost-effectiveness, and unexpected situations (like the COVID-19 pandemic). As an alternative method, telehealth has been used increasingly to meet the need for care in Veterans living in rural areas and during the pandemic. Telehealth delivery of cognitive interventions in Veterans with mTBI or with PTSD has shown effectiveness that is comparable to that of in-person treatment. However, GMT+ATT has not been studied in these Veterans. Therefore, the investigators have recently developed the format for telehealth delivery of GMT+ATT in Veterans with mTBI/PTSD. The preliminary data demonstrate the feasibility of this delivery platform and similar treatment outcomes as compared to in-person therapy.
Objective \& Hypotheses. The objective of this randomized controlled trial is to determine and compare the effect of in-person and telehealth delivery of GMT+ATT in Veterans with mTBI/PTSD.
Hypothesis 1a. In-person GMT+ATT will improve cognition vs. control group (Brain Health Workshop (BHW).
Hypothesis 1b. Telehealth GMT+ATT will improve cognition vs. BHW control group Hypothesis 2. Telehealth delivery of GMT+ATT will produce response comparable to in-person treatment. Primary measure. The NIH EXAMINER executive composite score will assess overall executive function with subdomains such as complex task performance requiring goal management, as well as tests underlying cognitive control such as attention and working memory. Secondary functional measures. 1) Unstructured Task and 2) Test of Grocery Shopping Skills (ToGSS), which captures naturalistic real-world function. Exploratory Objective. To study the capability of the Attention Network Task to predict treatment response to GMT+ATT.
Methods. 63 Veterans will be randomized to 10 weeks of in-person or telehealth delivery of GMT+ATT or BHW control. Outcomes will be assessed at pre-, post-, 6 month-post and 1-year post-treatment. GMT and ATT will each be provided in ten, weekly, 2-hour sessions (4hrs/week as combined).
Significance. This study uses a novel combinational treatment of GMT+ATT to restore the executive and attentional processes required for complex daily tasks in Veterans with mTBI/PTSD. This work meets a key VA RR\&D priority of providing quality care to Veterans. Positive study results may help shape clinical practice of cognitive rehabilitation in terms of treatment strategy, delivery platform, access to care, and means to predict treatment response. Such impacts will translate to significant cost-savings for the VA healthcare system and improvement in quality of life in Veterans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 63 randomized to three groups: In-patient intervention, Telehealth intervention and Control
| Arm | Type | Receives |
|---|---|---|
| Inpatient GMT plus Attention Training | Experimental | Behavioral: Goal Management Training plus Attention TrainingGoal 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. |
| Telehealth GMT plus Attention Training | Experimental | Behavioral: Goal Management Training plus Attention TrainingGoal 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 |
| Brain Health Workshop | Placebo comparator | Behavioral: Brain Health Workshop and National Geographic MoviesBrain 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. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Veterans who have served in OIF-OEF-OND and have been diagnosed with both a mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) based on the joint criteria of the Veterans' Affairs and Department of Defense (VA \& DoD)
- Latest mTBI occurred at least 6 months prior to study enrollment
- Attention deficit of 1.5 SD below the mean of the RBANS attention index
- Family member or friend that is willing to complete a questionnaire
- Access to a home computer, or smartphone with internet access
Key exclusion criteria (12 listed)
- History of pre-morbid learning disability
- History of psychiatric diagnosis sufficiently severe to have resulted in inpatient hospitalization
- Neurological disease unrelated to TBI (seizure disorder, stroke)
- Score < 90 on National Adult Reading Test (NART)
- Failure of validity testing on the Test of Memory Malingering (TOMM)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal Management Training plus Attention TrainingAlso: GMT + ATTGMT is a Power Point directed interactive group training to use a five point strategy to plan and execute complex tasks. Attention Training utilizes Brain HQ attention modules and individualized attention goals. | Behavioural | Inpatient GMT plus Attention Training, Telehealth GMT plus Attention Training |
| Brain Health Workshop and National Geographic MoviesAlso: BHW and National Geographic MoviesBHW is a Power Point directed interactive training to learn about the brain and cognitive components. National Geographic Movies, participants select movies to watch with the therapists and answers questions regarding the content. | Behavioural | Brain Health Workshop |
Primary outcome
Change in the Composite Executive score of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research
Time frame: pre-intervention, post, 6-month and 1-year follow-up
computerized performance measure that assess overall executive function. Composite Executive score, which is a single score that represent performance across the Dot Counting, N-back, Flanker, Continuous Performance Test, Fluency subscales, with a range of -3.0 to 3.0 with higher scores indicating better executive function.
5 secondary outcomes
Change in the Test of Grocery Shopping Skills
Time frame: week 1, week 11
Change in the attention index of the Repeatable Battery for the Assessment of Neuropsychological Status
Time frame: week 1, week 11, week 35 and week 59
Change in Attention Network Task
Time frame: week 1, week 11, week 35 and week 59
Change in Traumatic Brain Injury-Quality of Life, Participation Ability and Satisfaction short-form
Time frame: week 1, week 11, week 35 and week 59
Change in the Unstructured Task of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research
Time frame: week 1, week 11, week 35 and week 59
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julia K. Waid-Ebbs, PhD principal investigator
North Florida/South Georgia Veterans Health System, Gainesville, FL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal Management Training plus Attention Training and Brain Health Workshop and National Geographic Movies in people with Brain Injury and Cognition, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margaret H McCallum ((352) 376-1611 ext. 5223, Margaret.McCallum@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Composite Executive score of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (time frame: pre-intervention, post, 6-month and 1-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.