- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02352441
Cognitive Rehabilitation:ACTION Training for Soldiers With Executive Dysfunction (ACTION)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kentucky
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Fort Campbell North, Kentucky, United States, 42223
- Fort Campbell Intrepid Spirit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Implementation Intentions
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.
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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. |
No Intervention: Usual Care
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in performance of the Hotel Task
Time Frame: Baseline and end of 3 weeks
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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.
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Baseline and end of 3 weeks
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Change in the Canadian Occupational Performance Measure
Time Frame: Baseline and end of 3 weeks
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Participants will provide their self-perceived performance on three everyday tasks identified and prioritized as problematic.
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Baseline and end of 3 weeks
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Change in Goal Attainment Scaling
Time Frame: Baseline and end of 3 weeks
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Attainment of five goals linked to selected five everyday tasks
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Baseline and end of 3 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Monitoring performance of the assigned event or time based task, Yes(2 points)/No(0 points)/Partial(1 point)
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End of sessions 1 and 2 for each of weeks 1, 2, and 3
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Performance of homework
Time Frame: 4 days / week for each of the 3 weeks of study participation
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Participant will be expected to call in and report having done assignment
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4 days / week for each of the 3 weeks of study participation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mary Radomski, OTR/L, PhD, Allina Health
- Principal Investigator: Mark Showers, MS, OTR/L, Fort Campbell
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11215006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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