Metacognitive Training to Enhance Strategy Use In Blast Related TBI

说明： 背景：创伤性脑损伤被称为伊拉克自由行动/持久自由行动/新黎明行动(OIF/OEF/OND)战争的标志性损伤。仅在2012年，就有超过2.5万名士兵被诊断为轻度创伤性脑损伤(MTBI)。士兵不仅患有与爆炸相关的mTBI，据估计，合并创伤后应激障碍(PTSD)的比例从11%到50%不等。由于mTBI和PTSD影响的神经机制往往是重叠的，因此mTBI和PTSD对症状的影响可能是相加的。事实上，估计有44%-50%的患有mTBI/PTSD的士兵在一年后仍然有症状，相比之下，与运动相关的脑震荡估计只有10%。创伤后应激障碍和创伤后应激障碍都与执行功能缺陷有关。伴随着退伍军人mTBI的其他因素是抑郁和睡眠不足。因此，所有这些因素的结合，影响了执行职能，并导致战斗退伍军人努力过着富有成效的生活。需要对执行功能进行有效的治疗 被诊断为脑外伤的退伍军人。目标管理培训(GMT)是一种元认知干预措施，已在任务型教学中得到验证。然而，GMT研究的局限性提出了关于GMT在mTBI中的有效性的问题。根据初步数据，GMT在患有爆炸相关mTBI的退伍军人中的问题解决措施方面有显著改善，但缺乏转移到日常活动中。因此，我们开发了一款智能手机应用程序，以增强GMT技能向日常任务的迁移。目的：这项随机研究的目的是确定一种利用智能手机技术增强执行功能的创新治疗方法对患有多发性冲击波相关mTBI的退伍军人的效果。除了确定GMT的总体好处外，该研究还将调查创伤后应激障碍、抑郁症、睡眠障碍和认知能力等共病因素的影响。方法：语音服务公司将从两个地点(坦帕和北佛罗里达/南乔治亚州)招募被诊断为重复爆炸相关mTBI和执行功能缺陷的退伍军人。退伍军人将被随机分到GMT组(38名参与者)或被称为脑健康研讨会(BHW)的对照治疗组(16名参与者)。伦敦塔是一种衡量计划和解决问题的指标，将用来确定治疗的反应。初步分析将使用两个样本t检验来比较A组(干预组)和B组(对照组)在完成TOL的时间方面的改善情况。此外，作为探索性分析，我们将进行回归分析，将治疗组、创伤后应激障碍严重程度及其交互作用作为自变量，以调整临床医生使用的创伤后应激障碍量表测量的创伤后应激障碍严重程度，并调查治疗组与创伤后应激障碍严重程度之间是否存在交互作用。此外，使用配对t检验的探索性第三次分析将确定治疗效果是否适用于日常活动中的执行功能表现(Brief-A)或社区参与(CRIS)。为了测试第二个具体目标，将使用一般线性回归来确定创伤后应激障碍、睡眠、抑郁或认知能力等因素是否与治疗反应有关。结果：如果结果支持这样的假设，即GMT将改善执行功能，那么这种认知干预可以适应远程健康的交付方法，并在更大的临床试验中进行测试。此外，这四个因素对治疗反应的影响，可以指导未来的研究，以确定哪些患者可能从GMT中受益。

DESCRIPTION: Background: Traumatic brain injury has been referred to as the "signature" injury of the Operation Iraqi Freedom/Operation Enduring Freedom/Operation New Dawn (OIF/OEF/OND) wars. Over 25,000 soldiers were diagnosed with mild traumatic brain injury (mTBI) in 2012 alone. Not only do soldiers have blast-related mTBI, estimates of comorbid Post Traumatic Stress Disorder (PTSD), range from 11% to 50%. Since neural mechanisms affected by mTBI and PTSD often are overlapping, it is suggested that mTBI and PTSD may have an additive effect on symptoms. Indeed, an estimated 44-50% of soldiers with mTBI/PTSD remain symptomatic after one-year, compared to an estimated 10% in sports related concussion. Both mTBI and PTSD are associated with deficits in executive functioning. Additional factors that accompany mTBI in combat Veterans are depression and sleep deficits. Consequently, the combination of all these factors, impact executive functions and result in combat Veterans who are struggling to live productive lives. An effective treatment of executive function is needed for Veterans diagnosed with mTBI. Goal Management Training (GMT) is a metacognitive intervention that has been validated in TBI. However, limitations in GMT studies raise questions regarding effectiveness of GMT in mTBI. Based on preliminary data, GMT improved significantly on a problem solving measure in Veterans with blast-related mTBI, but lacked transfer to everyday activities. Therefore, we developed a Smartphone application to enhance the transfer of GMT skills to everyday tasks. The purpose: of this randomized study is to determine the effect of an innovative treatment for executive functions, enhanced with Smartphone technology, in Veterans with multiple blast related mTBI. In addition to determining the overall benefit of GMT, the study will investigate the influence of comorbid factors, such as post-traumatic stress disorder, depression, sleep disorders and cognitive capacity. Method: Veterans diagnosed with repeat blast-related mTBI and executive function deficit will be recruited from two sites (Tampa and North Florida/South Georgia) by Speech Services. Veterans will be randomized to GMT (38 participants) or to a control treatment called Brain Health Workshop (BHW) (16 participants).The Tower of London, a measure of planning and problem solving will be used to determine response to treatment. Primary analysis will use two sample t-test to compare group A (intervention) and group B (control) on improvements in time to completion on the TOL. In addition, as an exploratory analysis, we will perform a regression analysis that includes treatment group, PTSD severity and their interaction as independent variables, to adjust for PTSD severity measured by Clinician Administered PTSD Scale and to investigate whether there is interaction between treatment group and PTSD severity. Additional, exploratory tertiary analysis using paired t-tests will determine whether treatment effect generalizes to executive function performance in everyday activities (BRIEF-A) or engagement in community participation (CRIS). To test the second specific aim, a general linear regression will be used to determine whether factors such as PTSD, sleep, depression or cognitive capacity is associated with response to treatment. Results: If the results support the hypothesis that GMT will improve executive functions than this cognitive intervention can be adapted to a tele-health method of delivery and tested in a larger clinical trial. Moreover, the influence of the four factors on response to treatment, can guide future studies to determine which patients are likely to benefit from GMT.