Mild Traumatic Brain InjuryNCT04044456
Combining Attention and Metacognitive Training to Improve Goal Directed Behavior in Veterans With TBI
A study testing Goal Management Training, Attention Training and Brain Health Workshop in people with Mild Traumatic Brain Injury, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Veterans with mild traumatic brain injury continue to deal with symptoms that interfere with their ability to engage in productive activities. In combination with other psychosocial difficulties, impairments are found in cognition, such as attention and executive function. Read more about this study
- Who is it for?
- Ages 19 to 55 years
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- Goal Management Training, Attention Training and Brain Health Workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Veterans with a diagnosis mTBI between the ages of 18 to 55, that demonstrate a deficit in attention, pass effort testing and have not changed psychotropic medication within the past two weeks.
- all Veterans who have served in OIF-OEF-OND with single- (at least brief loss of conscious) or multiple (with at least alteration of consciousness) mild traumatic brain injury (mTBI) during deployment, who seek services at North Florida/South Georgia Veterans Health System (NF-VHS).
- TBI must have suffered their injury at least 6 months prior to study enrollment and currently be in stable neurological condition.
- age range 19-55 years to reduce the impact of aging on treatment improvement.
- Attention deficit of 1.5 SD below the mean of the RBANS attention index. This will ensure that participants have an objective deficit attention.
- Family member or friend that is willing to complete the BRIEF-A (BRIEF-A guidelines of face to face interaction with the participant at least twice a week) at all measurement time points.
- 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 either the Test of Memory Malingering (TOMM),). Score of 45 or less on TOMM Trial 2 or retention trial.
- Reported alcohol or substance abuse within the past year
Show all 13Show fewer
- Reported involvement in current litigation
- 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.
- Psychotropic drugs that have changed within the past two-weeks that would impact performance during assessment.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608
About this study
Veterans with mild traumatic brain injury continue to deal with symptoms that interfere with their ability to engage in productive activities. In combination with other psychosocial difficulties, impairments are found in cognition, such as attention and executive function. Few interventions are available to treat attention in Veterans with mTBI. Of the interventions available, none rigorously train attention combined with strategy training. This project will innovatively combine a strategy training called Goal Management Training with computerized attention training to improve tests of problem solving, attention and functional tasks compared to a control group.
Read the detailed description
This is a pilot study to test the effect of GMT plus Attention Training for Veterans with chronic mTBI. The research design is a parallel study with randomization to treatment or control with test administration at pre/post and six months following treatment. The investigators will enroll 50 Veterans with a diagnosis mTBI between the ages of 18 to 55, that demonstrate a deficit in attention, pass effort testing and have not changed psychotropic medication within the past two weeks. Treatment utilizes GMT for 10-weekly two-hour sessions and Brain HQ/Attention Process Training III for 10-weekly two-hour sessions. Control utilizes a complimentary Brain Health Workshop for 10-weely two-hour sessions and National Geographic movies for 10-weekly two-hour sessions.
Aim 1: Determine the treatment effect of attention training combined with GMT in Veterans with mTBI.
Hypothesis 1: GMT plus attention training will significantly improve performance on tests of cognition compared to the control group.
Primary measure: Computerized Tower of London (cTOL) total time, time to first move and optimal moves). The investigators have found significant improvement in cTOL following GMT in previous cohorts of Veterans with blast-related mTBI and anticipate improvement following a combined intervention.
Secondary measure: Attention Network Task (ANT) reaction time and errors for one or all dissociable components of three attentional systems (orienting, alerting, executive control) following intervention. There is little understanding of components of impaired attention and how it impacts executive function; therefore, there is limited guidance in shaping cognitive training. The investigators will conduct an experimental task (attention network task) that disassociates three attentional components (alerting, orienting, and executive control). The investigators will specifically target the orienting component of attention that is problematic for Veterans with mTBI and PTSD24, 26. Attentional processes are vital to goal-directed behavior. There is great potential in the use of these measures to identify individual differences (type of attention deficit) that could moderate treatment-related improvement and inform targeted interventions.
Hypothesis 2: Treatment gains will translate to functional activities compared to controls.
Primary measure of functional performance: test of grocery shopping skills (TOGSS) total time and optimal strategy use. The TOGSS captures efficiency in completing a real-world task and aligns with the strategy skills learned in GMT.
Secondary measure of community participation, the Community Reintegration of Servicemembers (CRIS) extent of participation. The CRIS demonstrated significant GMT treatment effect compared to controls in Veterans with mTBI. The combined treatment of attention training using drill training and implementing strategies to improve attention in a functional setting through GMT will potentiate treatment effect to functional activities. Measuring functional improvement through performance-based measures and self-report of engagement in activities will demonstrate treatment translation.
Tertiary analysis will be conducted on moderator variables: PTSD symptoms, Pain, History of Substance Abuse, Depression, number of concussions and combat exposure.
Successful completion of the proposed study will provide insight into the effectiveness of the innovative combined treatment of attention and executive function in Veterans with mTBI and PTSD. Use of the ANT could better target treatment and lead to future examination of attention treatment on neuroplasticity.
A multiple linear regression model will be used to determine if there is a significant association between treatment effect and comorbidities such as PTSD, depression, anxiety, pain, sleep, substance abuse, etc.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- Goal Management Training, Attention Training, Brain Health Workshop, National geographic movies
- Keywords
- Brain Injury, Cognition, Veteran, Attention, Metacognition
- Medical subject headings
- Brain Concussion, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal Management TrainingBehavioural
Also called GMT
GMT: is a 10-session intervention to improve planning and problem solving. Interactive Power Point modules are administered by a cognitive therapist. Each session builds on the steps of a five-stage planning and problem-solving strategy. Veterans will be taught to generate and verbalize the following five-steps: "stop-what am I doing?", "define the goal", "list the steps", "learn the steps"; then, "check-am I doing what I planned?" The five-stage strategy is then incorporated into a variety of activities in the laboratory and in-home assignments.
Attention TrainingBehavioural
Also called APT III, Brain HQ
Attention Process Training (APT-III) will be administered for a second weekly session in addition to the GMT session. Each session will be 2 hours/ week for 10 weeks. Veterans will also engage in BrainHQTM attention training at home for one-hour, five days/ week comprised of selected components of BrainHQ from Posit Science Corporation. This web-based computerized CRT modality of cognitive training is a restorative or "bottom-up" approach that targets basic cognitive skills such as arousal and vigilance processes, attention and information processing, and directly engages fundamental attention-control skills through repetitive graded exercises.
Brain Health WorkshopBehavioural
Also called BHW
. BHW was developed specifically for consistency with GMT session length and contact with the facilitator49. BHW is an education presentation on brain function and cognitive principles of learning with homework and quizzes on information covered. To match time and contact of attention training, control participants will meet with the therapist for a separate two-hour session from BHW
National geographic moviesBehavioural
Also called movies
participants will select movies to watch and answer a few questions about to equate the time and therapist interaction to attention training in arm 1.
| Study group | Role | What they receive |
|---|---|---|
| GMT plus attention | Experimental | GMT consists of 2-hour, 10 weekly sessions using an interactive Power Point presentations. Attention training consists of 2-hour computerized attention training using Attention Process Training III and Brain HQ. Receives: Behavioral: Goal Management Training; Behavioral: Attention Training |
| BHW plus movies | Placebo comparator | Brain Health Workshop consists of 2-hour, 10 weekly sessions using Power Point presentations and national geographic movies (2-hour, 10 weekly sessions). Receives: Behavioral: Brain Health Workshop; Behavioral: National geographic movies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computerized Tower of London Average Time to Complete Problems/Total Time
Computerized Tower of London (cTOL) total time, week 1, week 11 and week 36. Complete game board of three colored balls to match goal board in the least amount of moves and as quickly as possible. range of total time is 0-59 seconds with lower time=better performance.
Measured: week 1, 11, 36
Test of Grocery Shopping Skills
Total time, week 1 and week 11 on a task of shopping in a local grocery store for 10 items as efficiently as possible, while selecting the correct size and cheapest unit cost. Total time with lower times=better performance.
Measured: week 1, 11
Secondary outcomes (2)
Attention Network Task
Flanker task that dissociates attention into three components: alerting, orienting and executive control. Attention network effects were calculated using the following mean response time (RT) subtractions: alerting effect = no-cue RT minus center cue RT; orienting effect = invalid spatial cue RT minus valid spatial cue RT; executive control (conflict) effect = incongruent RT minus congruent RT. Mean response time for week 1, week 11 and week 36 on each component., lower=better performance.
Measured: week 1, 11, 36
Community Reintegration of Service Members
week 1, 11 and to week 36. The scale for each of the 46 items ranged from 1=extremely unsatisfied to 5=extremely satisfied. The total score is the mean of the responses of 46 items X 10. The range is 10 to 50 with higher numbers indicating better satisfaction with participation in the community.
Measured: week 1, 11, 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Traumatic 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
- participants meeting inclusion criteria will be randomized to either treatment (Goal management training and attention training) or control (Brain Health Workshop and national geographic movies).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
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
- NCT04044456
- Sponsor's protocol ID
- N3189-P
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2019
- Last updated
- 30 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Attention and Metacognitive Training to Improve Goal Directed Behavior in Veterans With TBI
- ClinicalTrials.gov ID
- NCT04044456
- Acronym / sponsor ID
- N3189-P
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- Brain Injury, Cognition, Veteran, Attention, Metacognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Posted 30 Aug 2024
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 continue to deal with symptoms that interfere with their ability to engage in productive activities. In combination with other psychosocial difficulties, impairments are found in cognition, such as attention and executive function. Few interventions are available to treat attention in Veterans with mTBI. Of the interventions available, none rigorously train attention combined with strategy training. This project will innovatively combine a strategy training called Goal Management Training with computerized attention training to improve tests of problem solving, attention and functional tasks compared to a control group.
Detailed description
This is a pilot study to test the effect of GMT plus Attention Training for Veterans with chronic mTBI. The research design is a parallel study with randomization to treatment or control with test administration at pre/post and six months following treatment. The investigators will enroll 50 Veterans with a diagnosis mTBI between the ages of 18 to 55, that demonstrate a deficit in attention, pass effort testing and have not changed psychotropic medication within the past two weeks. Treatment utilizes GMT for 10-weekly two-hour sessions and Brain HQ/Attention Process Training III for 10-weekly two-hour sessions. Control utilizes a complimentary Brain Health Workshop for 10-weely two-hour sessions and National Geographic movies for 10-weekly two-hour sessions.
Aim 1: Determine the treatment effect of attention training combined with GMT in Veterans with mTBI.
Hypothesis 1: GMT plus attention training will significantly improve performance on tests of cognition compared to the control group.
Primary measure: Computerized Tower of London (cTOL) total time, time to first move and optimal moves). The investigators have found significant improvement in cTOL following GMT in previous cohorts of Veterans with blast-related mTBI and anticipate improvement following a combined intervention.
Secondary measure: Attention Network Task (ANT) reaction time and errors for one or all dissociable components of three attentional systems (orienting, alerting, executive control) following intervention. There is little understanding of components of impaired attention and how it impacts executive function; therefore, there is limited guidance in shaping cognitive training. The investigators will conduct an experimental task (attention network task) that disassociates three attentional components (alerting, orienting, and executive control). The investigators will specifically target the orienting component of attention that is problematic for Veterans with mTBI and PTSD24, 26. Attentional processes are vital to goal-directed behavior. There is great potential in the use of these measures to identify individual differences (type of attention deficit) that could moderate treatment-related improvement and inform targeted interventions.
Hypothesis 2: Treatment gains will translate to functional activities compared to controls.
Primary measure of functional performance: test of grocery shopping skills (TOGSS) total time and optimal strategy use. The TOGSS captures efficiency in completing a real-world task and aligns with the strategy skills learned in GMT.
Secondary measure of community participation, the Community Reintegration of Servicemembers (CRIS) extent of participation. The CRIS demonstrated significant GMT treatment effect compared to controls in Veterans with mTBI. The combined treatment of attention training using drill training and implementing strategies to improve attention in a functional setting through GMT will potentiate treatment effect to functional activities. Measuring functional improvement through performance-based measures and self-report of engagement in activities will demonstrate treatment translation.
Tertiary analysis will be conducted on moderator variables: PTSD symptoms, Pain, History of Substance Abuse, Depression, number of concussions and combat exposure.
Successful completion of the proposed study will provide insight into the effectiveness of the innovative combined treatment of attention and executive function in Veterans with mTBI and PTSD. Use of the ANT could better target treatment and lead to future examination of attention treatment on neuroplasticity.
A multiple linear regression model will be used to determine if there is a significant association between treatment effect and comorbidities such as PTSD, depression, anxiety, pain, sleep, substance abuse, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- participants meeting inclusion criteria will be randomized to either treatment (Goal management training and attention training) or control (Brain Health Workshop and national geographic movies).
| Arm | Type | Receives |
|---|---|---|
| GMT plus attention | Experimental | Behavioral: Goal Management Training, Behavioral: Attention TrainingGMT consists of 2-hour, 10 weekly sessions using an interactive Power Point presentations. Attention training consists of 2-hour computerized attention training using Attention Process Training III and Brain HQ. |
| BHW plus movies | Placebo comparator | Behavioral: Brain Health Workshop, Behavioral: National geographic moviesBrain Health Workshop consists of 2-hour, 10 weekly sessions using Power Point presentations and national geographic movies (2-hour, 10 weekly sessions). |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Veterans with a diagnosis mTBI between the ages of 18 to 55, that demonstrate a deficit in attention, pass effort testing and have not changed psychotropic medication within the past two weeks.
- all Veterans who have served in OIF-OEF-OND with single- (at least brief loss of conscious) or multiple (with at least alteration of consciousness) mild traumatic brain injury (mTBI) during deployment, who seek services at North Florida/South Georgia Veterans Health System (NF-VHS).
- TBI must have suffered their injury at least 6 months prior to study enrollment and currently be in stable neurological condition.
- age range 19-55 years to reduce the impact of aging on treatment improvement.
- Attention deficit of 1.5 SD below the mean of the RBANS attention index. This will ensure that participants have an objective deficit attention.
Key exclusion criteria (13 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 either the Test of Memory Malingering (TOMM),). Score of 45 or less on TOMM Trial 2 or retention trial.
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 TrainingAlso: GMTGMT: is a 10-session intervention to improve planning and problem solving. Interactive Power Point modules are administered by a cognitive therapist. Each session builds on the steps of a five-stage planning and problem-solving strategy. Veterans will be taught to generate and verbalize the following five-steps: "stop-what am I doing?", "define the goal", "list the steps", "learn the steps"; then, "check-am I doing what I planned?" The five-stage strategy is then incorporated into a variety of activities in the laboratory and in-home assignments. | Behavioural | GMT plus attention |
| Attention TrainingAlso: APT III, Brain HQAttention Process Training (APT-III) will be administered for a second weekly session in addition to the GMT session. Each session will be 2 hours/ week for 10 weeks. Veterans will also engage in BrainHQTM attention training at home for one-hour, five days/ week comprised of selected components of BrainHQ from Posit Science Corporation. This web-based computerized CRT modality of cognitive training is a restorative or "bottom-up" approach that targets basic cognitive skills such as arousal and vigilance processes, attention and information processing, and directly engages fundamental attention-control skills through repetitive graded exercises. | Behavioural | GMT plus attention |
| Brain Health WorkshopAlso: BHW. BHW was developed specifically for consistency with GMT session length and contact with the facilitator49. BHW is an education presentation on brain function and cognitive principles of learning with homework and quizzes on information covered. To match time and contact of attention training, control participants will meet with the therapist for a separate two-hour session from BHW | Behavioural | BHW plus movies |
| National geographic moviesAlso: moviesparticipants will select movies to watch and answer a few questions about to equate the time and therapist interaction to attention training in arm 1. | Behavioural | BHW plus movies |
Primary outcome
Computerized Tower of London Average Time to Complete Problems/Total Time
Time frame: week 1, 11, 36
Computerized Tower of London (cTOL) total time, week 1, week 11 and week 36. Complete game board of three colored balls to match goal board in the least amount of moves and as quickly as possible. range of total time is 0-59 seconds with lower time=better performance.
Test of Grocery Shopping Skills
Time frame: week 1, 11
Total time, week 1 and week 11 on a task of shopping in a local grocery store for 10 items as efficiently as possible, while selecting the correct size and cheapest unit cost. Total time with lower times=better performance.
2 secondary outcomes
Attention Network Task
Time frame: week 1, 11, 36
Community Reintegration of Service Members
Time frame: week 1, 11, 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
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, Attention Training and Brain Health Workshop in people with Mild Traumatic Brain Injury, 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 7 inclusion and 13 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: finished, as of the sponsor's last update on 30 Aug 2024. 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?
Yes. Results are posted in the registry (first posted 30 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computerized Tower of London Average Time to Complete Problems/Total Time (time frame: week 1, 11, 36). The study lists 2 primary outcomes in all. 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 30 Aug 2024.