Cognitive Rehabilitation:ACTION Training for Soldiers With Executive Dysfunction (ACTION)
|ClinicalTrials.gov Identifier: NCT02352441|
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : January 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Other: Implementation Intentions(II)||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cognitive Rehabilitation:ACTION Training for Soldiers With Executive Dysfunction|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||September 29, 2017|
|Actual Study Completion Date :||September 29, 2017|
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.
Other: 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.
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.
- 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
- 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 ]Monitoring performance of the assigned event or time based task, Yes(2 points)/No(0 points)/Partial(1 point)
- Performance of homework [ Time Frame: 4 days / week for each of the 3 weeks of study participation ]Participant will be expected to call in and report having done assignment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352441
|United States, Kentucky|
|Fort Campbell Intrepid Spirit|
|Fort Campbell North, Kentucky, United States, 42223|
|Principal Investigator:||Mary Radomski, OTR/L, PhD||Allina Health|
|Principal Investigator:||Mark Showers, MS, OTR/L||Fort Campbell|