Traumatic Brain InjuryACTIONNCT02352441
Cognitive Rehabilitation:ACTION Training for Soldiers With Executive Dysfunction
A study testing Implementation Intentions(II) in people with Traumatic Brain Injury, run by Allina Health System at 1 site in United States.
Trial summary
Many Service members (SM) experience executive dysfunction associated with mild traumatic brain injury symptom complex (mTBI-sc), for which they receive cognitive rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Implementation Intentions(II)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 29 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:The sample population at the Traumatic Brain Injury Clinic- Fort Campbell (TBIC-FC) will consist of active duty army soldiers, reservists, national guardsmen, airmen, and retirees; the majority of the sample population will be active duty army soldiers. Study volunteers will be recruited from among service members assessed in the TBIC-FC and referred to the Cognitive Clinic for performance problems secondary to reported / suspected combat-related mTBI-sc.
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Exclusion Criteria:Not willing to sign consent to participate.
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Trial locations and contacts
1 site in 1 country.
United States1 site
Fort Campbell Intrepid Spirit
Fort Campbell North, Kentucky, 42223
About this study
Many Service members (SM) experience executive dysfunction associated with mild traumatic brain injury symptom complex (mTBI-sc), for which they receive cognitive rehabilitation. Cognitive rehabilitation (CR) for executive dysfunction often involves metacognitive strategy instruction (MSI) to help patients self-regulate their behavior though a goal management process - identifying a goal, anticipating performance problems, generating possible solutions, self-monitoring performance during the activity, recognizing maladaptive task strategies, stopping and then modifying real-time task behavior by choosing an alternate strategy. MSI alone often does not result in improved daily functioning because it requires conscious cognitive oversight to employ (which is difficult for people with executive dysfunction) and it presumes that simply establishing goals propels goal-directed action, when for many people, this is not so. Social psychologists report that people who set implementation intentions (if-then statements that link specific situational cues with specific goal actions) are more likely to perform goal actions than those who only set goal intentions. Implementation intentions are believed to be effective because they enable people to switch from conscious-effortful reflective action control to automatic, reflexive action control associated with selected situational cues. A team of researchers from the Courage Kenny Research Center (CKRC), Traumatic Brain Injury Center at Fort Campbell, KY (TBIC-FC), and Neurofunctional Research and Consulting has developed a brief CR intervention to teach SM with mTBI-sc to set implementation intentions called ACTION (AutomatiC iniTiation of IntentiONs) sequence training. The purpose of this pilot study to evaluate: 1) the practicality of instructional methods used to teach SM with mTBI-sc to perform the ACTION sequence and 2) the efficacy of ACTION sequence training in achieving personal goals and performance on a task that challenges executive function using a small randomized controlled trial. If the results are positive, a larger study would be conducted to determine the impact of ACTION sequence training on SM performance on military-relevant tasks and goals.
Read the detailed description
The primary aims of this feasibility study are as follows:
Aim 1: Finalize ACTION training curriculum; develop manuals; field test .
- Work with implementation intentions research expert and a military consultant to develop a training task gradation schema which informs the identification and modification of existing implementation intentions training tasks so that they have military face validity.
- Finalize the adherence support methods and other training worksheets and materials.
- Field test training tasks and adherence support methods on small cohort of civilians with mTBI-sc from CKRC to assure feasibility.
- Finalize ACTION sequence training manuals; assure intra-rater and inter-rater reliability for scoring quality of implementation intentions statements.
Aim 2: Evaluate ACTION sequence training instructional methods (the extent to which SM with mTBI-sc are able to learn to establish IF-THEN statements that have the potential to trigger automatic enactment of goal-actions and the extent to which SM with mTBI-sc report the training experience as satisfactory and beneficial).
- Enroll up to 28 participants in the study (SM with mTBI-sc who are referred to MSI at TBIC-FC).
- Evaluate whether or not participants can correctly craft implementation intentions by using a rubric to score implementation intentions developed by participants during clinic sessions and during home practice; administer participation satisfaction survey at posttest.
Aim 3: Test the efficacy of ACTION sequence training by evaluating the extent to which training 1) improves SM's with mTBI-sc ability to perform a complex test of executive function (e.g. Hotel Test) and 2) advances progress towards self-identified goals in daily life (via Canadian Occupational Performance measure [COPM] and Goal Attainment Scaling [GAS]) as compared to a control condition. Additionally, determine level of adherence to completing daily homework practice ans assigned prospective memory tasks.
- Collect pre-post data on the Hotel Test, COPM, GAS on all participants.
- Collect data on completion of homework assignments
- Collect data on completion of prospective memory tasks
- Conditions
- Traumatic Brain Injury
- Being tested
- Implementation Intentions(II)
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation Intentions(II)Other
Implementation Intention training will include:
Demonstration and practice using examples and personal goals identified at first session. Worksheets will be provided to practice IF-THEN statements to set Implementation Intentions. Additionally, at the end of each session, the participant will be instructed to perform and event based or time based task. The objective is to see if those receiving II training are more likely to carry out the assigned task than those who do not receive II training. They will also be expected to practice II at least 5 days/week using personal goals.
| Study group | Role | What they receive |
|---|---|---|
| Implementation Intentions | Experimental | This group will receive training in Implementation Intentions during 3 sessions, 1 day/week, over 3 weeks. They will receive usual care through the standard program, 1 day/week during these 3 weeks. Receives: Other: Implementation Intentions(II) |
| Usual Care | No intervention | This group will participate in the usual group intervention provided to Service members experiencing executive dysfunction associated with mild traumatic brain injury, 2 days / week during 3 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in performance of the Hotel Task
The Hotel Task requires the participant to perform a set of 6 tasks in 10 minutes with the instruction to perform all tasks with no expectation for completing any of the tasks. This task tests the ability of the participant to shift. Measurements associated with this task include time spent on each task and number of tasks completed.
Measured: Baseline and end of 3 weeks
Change in the Canadian Occupational Performance Measure
Participants will provide their self-perceived performance on three everyday tasks identified and prioritized as problematic.
Measured: Baseline and end of 3 weeks
Change in Goal Attainment Scaling
Attainment of five goals linked to selected five everyday tasks
Measured: Baseline and end of 3 weeks
Secondary outcomes (2)
Performance of assigned tasks given at the end of each of the 6 II sessions
Monitoring performance of the assigned event or time based task, Yes(2 points)/No(0 points)/Partial(1 point)
Measured: End of sessions 1 and 2 for each of weeks 1, 2, and 3
Performance of homework
Participant will be expected to call in and report having done assignment
Measured: 4 days / week for each of the 3 weeks of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startJun 2016
- Primary completion29 Sep 2017
- Study completion29 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Radomski, Allina Health System
- Investigators
- Mary Radomski, OTR/L, PhD, Principal investigator, Allina Health SystemMark Showers, MS, OTR/L, Principal investigator, Fort Campbell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352441
- Sponsor's protocol ID
- 11215006
- Acronym
- ACTION
- Status last verified
- Jan 2018
- First submitted
- 23 Jan 2015
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Radomski MV, Giles GM, Owens J, Showers M, Rabusch S, Kreiger R, Zola J, Kath K. Can service members with mild traumatic brain injury learn to develop implementation intentions for self-identified goals? Disabil Rehabil. 2022 Jun;44(12):2640-2647. doi: 10.1080/09638288.2020.1841309. Epub 2020 Nov 4.
PubMed 33147426
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation:ACTION Training for Soldiers With Executive Dysfunction
- ClinicalTrials.gov ID
- NCT02352441
- Acronym / sponsor ID
- ACTION / 11215006
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 2 Feb 2015 (estimated)
- 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.
Many Service members (SM) experience executive dysfunction associated with mild traumatic brain injury symptom complex (mTBI-sc), for which they receive cognitive rehabilitation. Cognitive rehabilitation (CR) for executive dysfunction often involves metacognitive strategy instruction (MSI) to help patients self-regulate their behavior though a goal management process - identifying a goal, anticipating performance problems, generating possible solutions, self-monitoring performance during the activity, recognizing maladaptive task strategies, stopping and then modifying real-time task behavior by choosing an alternate strategy. MSI alone often does not result in improved daily functioning because it requires conscious cognitive oversight to employ (which is difficult for people with executive dysfunction) and it presumes that simply establishing goals propels goal-directed action, when for many people, this is not so. Social psychologists report that people who set implementation intentions (if-then statements that link specific situational cues with specific goal actions) are more likely to perform goal actions than those who only set goal intentions. Implementation intentions are believed to be effective because they enable people to switch from conscious-effortful reflective action control to automatic, reflexive action control associated with selected situational cues. A team of researchers from the Courage Kenny Research Center (CKRC), Traumatic Brain Injury Center at Fort Campbell, KY (TBIC-FC), and Neurofunctional Research and Consulting has developed a brief CR intervention to teach SM with mTBI-sc to set implementation intentions called ACTION (AutomatiC iniTiation of IntentiONs) sequence training. The purpose of this pilot study to evaluate: 1) the practicality of instructional methods used to teach SM with mTBI-sc to perform the ACTION sequence and 2) the efficacy of ACTION sequence training in achieving personal goals and performance on a task that challenges executive function using a small randomized controlled trial. If the results are positive, a larger study would be conducted to determine the impact of ACTION sequence training on SM performance on military-relevant tasks and goals.
Detailed description
The primary aims of this feasibility study are as follows:
Aim 1: Finalize ACTION training curriculum; develop manuals; field test .
- Work with implementation intentions research expert and a military consultant to develop a training task gradation schema which informs the identification and modification of existing implementation intentions training tasks so that they have military face validity.
- Finalize the adherence support methods and other training worksheets and materials.
- Field test training tasks and adherence support methods on small cohort of civilians with mTBI-sc from CKRC to assure feasibility.
- Finalize ACTION sequence training manuals; assure intra-rater and inter-rater reliability for scoring quality of implementation intentions statements.
Aim 2: Evaluate ACTION sequence training instructional methods (the extent to which SM with mTBI-sc are able to learn to establish IF-THEN statements that have the potential to trigger automatic enactment of goal-actions and the extent to which SM with mTBI-sc report the training experience as satisfactory and beneficial).
- Enroll up to 28 participants in the study (SM with mTBI-sc who are referred to MSI at TBIC-FC).
- Evaluate whether or not participants can correctly craft implementation intentions by using a rubric to score implementation intentions developed by participants during clinic sessions and during home practice; administer participation satisfaction survey at posttest.
Aim 3: Test the efficacy of ACTION sequence training by evaluating the extent to which training 1) improves SM's with mTBI-sc ability to perform a complex test of executive function (e.g. Hotel Test) and 2) advances progress towards self-identified goals in daily life (via Canadian Occupational Performance measure [COPM] and Goal Attainment Scaling [GAS]) as compared to a control condition. Additionally, determine level of adherence to completing daily homework practice ans assigned prospective memory tasks.
- Collect pre-post data on the Hotel Test, COPM, GAS on all participants.
- Collect data on completion of homework assignments
- Collect data on completion of prospective memory tasks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implementation Intentions | Experimental | Other: Implementation Intentions(II)This group will receive training in Implementation Intentions during 3 sessions, 1 day/week, over 3 weeks. They will receive usual care through the standard program, 1 day/week during these 3 weeks. |
| Usual Care | No intervention | –This group will participate in the usual group intervention provided to Service members experiencing executive dysfunction associated with mild traumatic brain injury, 2 days / week during 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Implementation Intentions(II)Implementation Intention training will include: Demonstration and practice using examples and personal goals identified at first session. Worksheets will be provided to practice IF-THEN statements to set Implementation Intentions. Additionally, at the end of each session, the participant will be instructed to perform and event based or time based task. The objective is to see if those receiving II training are more likely to carry out the assigned task than those who do not receive II training. They will also be expected to practice II at least 5 days/week using personal goals. | Other | Implementation Intentions |
Primary outcome
Change in performance of the Hotel Task
Time frame: Baseline and end of 3 weeks
The Hotel Task requires the participant to perform a set of 6 tasks in 10 minutes with the instruction to perform all tasks with no expectation for completing any of the tasks. This task tests the ability of the participant to shift. Measurements associated with this task include time spent on each task and number of tasks completed.
Change in the Canadian Occupational Performance Measure
Time frame: Baseline and end of 3 weeks
Participants will provide their self-perceived performance on three everyday tasks identified and prioritized as problematic.
Change in Goal Attainment Scaling
Time frame: Baseline and end of 3 weeks
Attainment of five goals linked to selected five everyday tasks
2 secondary outcomes
Performance of assigned tasks given at the end of each of the 6 II sessions
Time frame: End of sessions 1 and 2 for each of weeks 1, 2, and 3
Performance of homework
Time frame: 4 days / week for each of the 3 weeks of study participation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- Derived from this study: PubMed 33147426Radomski MV, Giles GM, Owens J, Showers M, Rabusch S, Kreiger R, Zola J, Kath K. Can service members with mild traumatic brain injury learn to develop implementation intentions for self-identified goals? Disabil Rehabil. 2022 Jun;44(12):2640-2647. doi: 10.1080/09638288.2020.1841309. Epub 2020 Nov 4.
- 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.
Mary Radomski, OTR/L, PhD principal investigator
Allina Health System
Mark Showers, MS, OTR/L principal investigator
Fort Campbell
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation Intentions(II) in people with Traumatic Brain Injury, run by Allina Health System 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?
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 11 Jan 2018. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in performance of the Hotel Task (time frame: Baseline and end of 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02352441, which also lists 1 linked publication.
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 11 Jan 2018.