Cognitively Augmented Behavioral Activation for Veterans with Comorbid TBI/PTSD

描述(由申请人提供)： 从伊拉克和阿富汗目前的冲突中归来的退伍军人表现出很高的mTBI/PTSD并存的比率。考虑到这些疾病的共病和神经精神症状的重叠，很难确定功能问题和中断是由于mTBI、PTSD，还是两者兼而有之。因此，对于提供者来说，知道如何优先处理这些患者的临床问题以及如何有效地治疗他们是具有挑战性的。目前，还没有针对mTBI/PTSD并存的循证治疗方法。此外，目前还不清楚两种疾病的现有治疗方法能在多大程度上坚持并有效地应用于另一种疾病。因此，目前大多数治疗建议对合并mTBI/PTSD的患者采取整体或综合的治疗方法，以症状和功能为目标，而不是潜在的病因。我们正在提出一种治疗mTBI和PTSD并存的方法，直接针对日常功能和生活质量。这项研究的主要目的是评估认知增强行为激活(CABA)的疗效，这是一种新的混合疗法，用于治疗被诊断为轻度创伤性脑损伤(MTBI)和创伤后应激障碍(PTSD)的退伍军人。这项研究的具体目标是确定：1)CABA是否减轻患有mTBI/PTSD的退伍军人的PTSD症状；2)CABA减轻患有mTBI/PTSD的退伍军人的认知相关功能损害；3)CABA改善患有mTBI/PTSD的退伍军人的抑郁症状、认知功能和生活质量；以及4)CABA是患有mTBI/PTSD的退伍军人可以接受的治疗方法。总体目标是开发一种基于循证的、可在退伍军人健康管理局(VHA)治疗环境中实施的mTBI/PTSD并存的机械化治疗方法。研究设计利用位于俄勒冈州波特兰和华盛顿州西雅图的两个参与退伍军人管理局医疗中心(VAMC)的资源集中可用来进行CABA的随机对照试验(RCT)。这项研究将招募总共192名OEF/OIF退伍军人，每个地点96名参与者，在参与的VAMC登记，他们被诊断为mTBI和创伤后应激障碍。纳入标准将是1)能够提供知情同意的参与退伍军人管理局/OEF时代退伍军人，2)基于临床医生管理的创伤后应激障碍量表(Blake等人，1990)诊断的创伤后应激障碍，3)结构化访谈的阳性筛查，以收集VA/DoD震荡/mTBI临床实践指南概述的头部创伤事件特征，并肯定任何神经行为症状清单(NSI)认知症状项目(第13-17项)，4)会说英语，能够每周前往初级保健诊所10次会议和后续评估，并愿意避免在治疗活动阶段的头3个半月期间开始额外的心理健康治疗，如果他们被分配到卡巴病情，以及5)愿意参加录音治疗。排除标准将是：1)当前戒毒少于30天的物质依赖障碍；2)当前的躁郁症或精神障碍；3)表明有重大临床风险的积极自杀意图；4)在第一次评估前6周内开始服用精神药物；以及4)听觉或视觉障碍，使其无法参加认知康复小组或受益于补偿策略。符合条件的参与者将被随机分配到CABA或照常治疗(TAU)组。CABA组的参与者将在他们参与研究的前14周内接受CABA干预，而TAU参与者将在他们参与研究期间继续接受TAU(创伤后应激障碍专业治疗诊所的常规护理，但没有CABA)。两组都将在基线、7周(治疗中期)、14周(治疗后)和39周(6个月随访)进行评估。在他们参与研究期间，所有参与者将继续接受他们通常的医疗护理。

DESCRIPTION (provided by applicant): Veterans returning from the current conflicts in Iraq and Afghanistan exhibit high rates of comorbid mTBI/PTSD. Given the comorbidity and neuropsychiatric symptom overlap of these disorders, it can be difficult to determine whether problems and disruptions in functioning are due to mTBI, PTSD, or both. Hence, it is challenging for providers to know how to prioritize these patients' clinical issues and how to effectively treat them. Currently, there are no evidence-based treatments for comorbid mTBI/PTSD. Further, it is unclear to what extent existing treatments for each disorder can be adherently and effectively implemented for the other. As such, most current treatment recommendations suggest a holistic or integrated approach to treatment for comorbid mTBI/PTSD targeting symptoms and functionality rather than underlying etiology. We are proposing a treatment for comorbid mTBI and PTSD that directly targets daily functioning and quality of life. The primary objective of this study is to evaluate the efficacy of Cognitively Augmented Behavioral Activation (CABA), a new hybrid treatment for veterans diagnosed with comorbid mild Traumatic Brain Injury (mTBI) and posttraumatic stress disorder (PTSD). The study's specific goals are to determine whether: 1) CABA reduces PTSD symptoms in veterans with mTBI/PTSD, 2) CABA reduces cognitive-related functional impairment in veterans with mTBI/PTSD, 3) CABA results in improvements in depression symptoms, cognitive functioning, and quality of life in veterans with mTBI/PTSD; and 4) CABA is an acceptable treatment for veterans with mTBI/PTSD. The overall goal is to develop an evidence-based manualized treatment for comorbid mTBI/PTSD that can be readily implemented in Veterans Health Administration (VHA) treatment settings. The study design makes use of the convergent availability of resources at the two participating Veterans Administration Medical Centers (VAMCs) in Portland, Oregon, and Seattle, Washington to conduct a Randomized Controlled Trial (RCT) of CABA. The study will recruit a total of 192 OEF/OIF veterans, 96 participants at each site, enrolled at participating VAMCs who are diagnosed with both mTBI and PTSD. Inclusion criteria will be 1) OIF/OEF era Veterans enrolled at one of the participating VA sites who are able to provide informed consent, 2) Diagnosis of PTSD based on the Clinician Administered PTSD Scale (Blake et al., 1990), 3) Positive screen on the Structured Interview for Collecting Head Trauma Event Characteristics as outlined by the VA/DoD Clinical Practice Guideline for Management of Concussion/mTBI and positively endorsed any of the Neurobehavioral Symptom Inventory (NSI) cognitive symptoms items (items 13-17), 4) English speaking, able to travel to the primary care clinics weekly for 10 sessions and for the follow-up assessments, and willing to refrain from the initiation of additiona mental health treatment during the first 3 1/2 months of the active phase of treatment if they are assigned to the CABA condition, and 5) Willingness to participate in audio-recorded sessions. Exclusion criteria will be 1) Current substance dependence disorder with less than 30 days abstinence, 2) Current Bipolar or psychotic disorder, 3) Active suicidal intent indicating significant clinical risk, 4) Initiated psychotropic medication within 6 weeks prior to the first assessment; and 4) Auditory or visual impairments that would prevent ability to participate in the cognitive rehabilitation group or benefit from compensatory strategies. Eligible participants will be randomly assigned to either the CABA or Treatment as Usual (TAU) group. Participants in the CABA group will receive the CABA intervention during the first 14 weeks of their participation in the study, whereas TAU participants will continue to receive TAU (usual care in a PTSD specialty treatment clinic, but no CABA) during their participation in the study. Both groups will undergo evaluations at baseline, 7 weeks (mid-treatment), 14 weeks (post-treatment), and 39 weeks (6 month follow- up). During their study participation, all participants will continue to receive their usual medical care.