Cognitive Rehabilitation:ACTION Training for Soldiers With Executive Dysfunction

NCT02352441 | Completed

• 1 other identifier: 11215006
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Change in Goal Attainment Scaling

  Attainment of five goals linked to selected five everyday tasks

  Baseline and end of 3 weeks

Secondary Outcomes (2)

• Performance of assigned tasks given at the end of each of the 6 II sessions

  End of sessions 1 and 2 for each of weeks 1, 2, and 3

• Performance of homework

  4 days / week for each of the 3 weeks of study participation

Study Arms (2)

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.

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.

Interventions

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.

Implementation Intentions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Allina Health System: lead

Study Sites (1)

Fort Campbell Intrepid Spirit

Fort Campbell North, Kentucky, 42223, United States

Location

Related Publications (1)

• 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.

  PMID: 33147426 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Mary Radomski, OTR/L, PhD

  Allina Health

  PRINCIPAL INVESTIGATOR

• Mark Showers, MS, OTR/L

  Fort Campbell

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientific Advisor

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: February 2, 2015
• Study Start: June 1, 2016
• Primary Completion: September 29, 2017
• Study Completion: September 29, 2017
• Last Updated: January 11, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)