Cognitive Rehabilitation:ACTION Training for Soldiers With Executive Dysfunction

Traumatic Brain Injury Clinical Trial

— ACTION  

Official title:

Cognitive Rehabilitation:ACTION Training for Soldiers With Executive Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02352441
• Other study ID #: 11215006
• Status: Completed
• Phase: N/A
• First received: January 23, 2015
• Last updated: January 9, 2018
• Start date: June 2016
• Est. completion date: September 29, 2017

Study information

• Verified date: January 2018
• Source: Allina Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 29, 2017
• Est. primary completion date: September 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:Not willing to sign consent to participate.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

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.

Locations

Country	Name	City	State
United States	Fort Campbell Intrepid Spirit	Fort Campbell North	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Allina Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and end of 3 weeks
Primary	Change in the Canadian Occupational Performance Measure	Participants will provide their self-perceived performance on three everyday tasks identified and prioritized as problematic.	Baseline and end of 3 weeks
Primary	Change in Goal Attainment Scaling	Attainment of five goals linked to selected five everyday tasks	Baseline and end of 3 weeks
Secondary	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)	End of sessions 1 and 2 for each of weeks 1, 2, and 3
Secondary	Performance of homework	Participant will be expected to call in and report having done assignment	4 days / week for each of the 3 weeks of study participation