Cognitively Augmented Behavioral Activation for Veterans with Comorbid TBI/PTSD

描述（由申请人提供）： 从目前的伊拉克和阿富汗冲突中返回的退伍军人表现出高比例的共病mTBI/PTSD。鉴于这些疾病的合并症和神经精神症状重叠，很难确定功能障碍和功能障碍是否是由于mTBI，PTSD或两者兼而有之。因此，对于提供者来说，知道如何优先考虑这些患者的临床问题以及如何有效地治疗它们是具有挑战性的。目前，还没有针对mTBI/PTSD共病的循证治疗方法。此外，目前还不清楚在何种程度上现有的治疗每种疾病可以坚持和有效地实施其他。因此，目前大多数治疗建议建议采用整体或综合方法治疗mTBI/PTSD共病，目标是症状和功能，而不是潜在病因。我们正在提出一种治疗mTBI和PTSD共病的方法，直接针对日常功能和生活质量。本研究的主要目的是评估认知增强行为激活（CABA）的疗效，CABA是一种新的混合治疗方法，用于诊断患有轻度创伤性脑损伤（mTBI）和创伤后应激障碍（PTSD）的退伍军人。该研究的具体目标是确定：1）CABA是否减少mTBI/PTSD退伍军人的PTSD症状，2）CABA是否减少mTBI/PTSD退伍军人的认知相关功能障碍，3）CABA是否改善mTBI/PTSD退伍军人的抑郁症状，认知功能和生活质量; 4）CABA是否是mTBI/PTSD退伍军人可接受的治疗方法。总体目标是为mTBI/PTSD共病患者开发一种循证手动治疗方法，该方法可在退伍军人健康管理局（VHA）治疗环境中轻松实施。研究设计利用了两个参与的退伍军人管理局医疗中心（VAMC）（波特兰，俄勒冈州和西雅图，华盛顿）的资源聚合可用性，以进行CABA的随机对照试验（RCT）。该研究将招募总共192名OEF/OIF退伍军人，每个研究中心96名参与者，参加被诊断患有mTBI和PTSD的参与VAMC。入选标准将是1）在参与的VA站点之一招募的能够提供知情同意的OIF/OEF时代退伍军人，2）基于临床医生管理的PTSD量表的PTSD诊断（Blake等人，1990年），3）如VA/DoD脑震荡/mTBI管理临床实践指南所概述的，对收集头部创伤事件特征的结构化访谈进行积极筛选，并积极认可任何神经行为症状量表（NSI）认知症状项目（项目13 - 17），4）讲英语，能够每周前往初级保健诊所进行10次治疗和后续评估，如果他们被分配到CABA条件，愿意在治疗的积极阶段的前3个半月内避免开始额外的心理健康治疗，以及5）愿意参加录音会话。排除标准将是1）当前物质依赖性障碍，戒断少于30天，2）当前双相或精神障碍，3）表明显著临床风险的主动自杀意图，4）在首次评估前6周内开始精神药物治疗;以及4）听觉或视觉障碍，这将阻止参与认知康复组或从补偿策略中受益的能力。合格的受试者将被随机分配到CABA组或按剂量治疗（TAU）组。CABA组的参与者将在参与研究的前14周内接受CABA干预，而TAU参与者将在参与研究期间继续接受TAU（PTSD专科治疗诊所的常规护理，但没有CABA）。两组均将在基线、7周（治疗中期）、14周（治疗后）和39周（6个月随访）时进行评价。在参与研究期间，所有受试者将继续接受常规医疗护理。

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.