跳至主要内容
临床试验/NCT02352441
NCT02352441已完成不适用

Cognitive Rehabilitation:ACTION Training for Soldiers With Executive Dysfunction

Allina Health System2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Change in performance of the Hotel Task

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Not willing to sign consent to participate.

结局指标

主要结局

Change in performance of the Hotel Task

时间窗: 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

时间窗: 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

时间窗: Baseline and end of 3 weeks

Attainment of five goals linked to selected five everyday tasks

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary Radomski

Senior Scientific Advisor

Allina Health System

研究点 (2)

Loading locations...

相似试验