Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cognitive Rehabilitation:ACTION Training for Soldiers With Executive Dysfunction (ACTION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02352441
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Mary Radomski, Allina Health System

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Other: Implementation Intentions(II) Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Change in Goal Attainment Scaling [ Time Frame: Baseline and end of 3 weeks ]
    Attainment of five goals linked to selected five everyday tasks


Secondary Outcome Measures :
  1. 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)

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352441


Locations
Layout table for location information
United States, Kentucky
Fort Campbell Intrepid Spirit
Fort Campbell North, Kentucky, United States, 42223
Sponsors and Collaborators
Allina Health System
Investigators
Layout table for investigator information
Principal Investigator: Mary Radomski, OTR/L, PhD Allina Health
Principal Investigator: Mark Showers, MS, OTR/L Fort Campbell
Layout table for additonal information
Responsible Party: Mary Radomski, Senior Scientific Advisor, Allina Health System
ClinicalTrials.gov Identifier: NCT02352441    
Other Study ID Numbers: 11215006
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries