Cognitively Augmented Behavioral Activation for Veterans with Comorbid TBI/PTSD

患有共病 TBI/PTSD 的退伍军人的认知增强行为激活

• 批准号: 9260708
• 负责人: Daniel M Storzbach
• 金额: --
• 依托单位: PORTLAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-04-01 至 2019-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9260708
• 关键词: Abstinence; Address; Afghanistan; Aftercare; Auditory; Awareness; Behavioral; Bipolar Disorder; Caring; Characteristics; Clinic; Clinical; Clinical Practice Guideline; Cognitive; Comorbidity; Conflict (Psychology); Craniocerebral Trauma; Diagnosis; Disease; Effect Modifiers (Epidemiology); Effectiveness; Elements; Enrollment; Equipment and supply inventories; Etiology; Evaluation; Event; Evidence based treatment; Exclusion Criteria; Exhibits; Freedom; Goals; Healthcare; Hybrids; Informed Consent; Injury; Intervention; Interview; Investigation; Iraq; Link; Maintenance; Measures; Mediator of activation protein; Medical; Medical center; Mental Health; Mild Concussions; Modernization; Moods; Neurobehavioral Manifestations; Neuropsychological Tests; Oregon; Participant; Patient-Focused Outcomes; Patients; Pattern; Pharmaceutical Preparations; Phase; Population; Population Heterogeneity; Post-Traumatic Stress Disorders; Primary Health Care; Provider; Psychotic Disorders; Publishing; Quality of life; Randomized; Randomized Controlled Trials; Recommendation; Recruitment Activity; Rehabilitation therapy; Reporting; Research; Research Design; Resources; Severities; Site; Structure; Substance Addiction; Symptoms; Traumatic Brain Injury; Travel; Treatment Efficacy; Uncertainty; United States Department of Veterans Affairs; Veterans; Visual impairment; Walkers; War; Washington; associated symptom; base; clinical effect; clinical risk; cognitive function; cognitive rehabilitation; combat; daily functioning; depressive symptoms; design; effective therapy; eligible participant; evidence base; follow up assessment; follow-up; functional disability; health administration; holistic approach; improved; inclusion criteria; medical specialties; member; mild traumatic brain injury; neuropsychiatric symptom; operation; performance tests; prevent; public health relevance; satisfaction; secondary outcome; suicidal; therapy design; treatment as usual; willingness

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.

描述（由申请人提供）： 从伊拉克和阿富汗目前的冲突中返回的退伍军人表现出高度的MTBI/PTSD。考虑到这些疾病的合并症和神经精神症状重叠，可能很难确定问题和功能中的破坏是由于MTBI，PTSD还是两者兼而有之。因此，对于提供者而言，要知道如何优先考虑这些患者的临床问题以及如何有效治疗它们是一个挑战。目前，尚无对合并MTBI/PTSD的循证治疗。此外，目前尚不清楚在多大程度上可以忠实地有效地实施每种疾病的现有治疗方法。因此，大多数当前的治疗建议提出了一种整体或综合治疗方法，用于合并MTBI/PTSD靶向症状和功能，而不是基本的病因。我们正在提议对合并症MTBI和PTSD的治疗方法，该治疗直接针对日常工作和生活质量。这项研究的主要目的是评估认知增强行为激活（CABA）的疗效，这是一种新的杂种治疗，用于诊断为合并症轻度创伤性脑损伤（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是否减少了具有MTBI/PTSD的退伍军人的PTSD症状，2）CABA减少MTBI/PTSD的退伍军人的认知与认知相关的功能障碍，3）CABA在抑郁症状，认知功能和质量的veterains caba caba caba caba caba caba caba caba caba结果; 4）CABA是MTBI/PTSD的退伍军人的可接受治疗方法。总体目标是为合并症MTBI/PTSD开发基于证据的手动治疗，可以在退伍军人卫生管理局（VHA）治疗环境中很容易实施。研究设计利用了位于俄勒冈州波特兰市和华盛顿西雅图的两个参与的退伍军人管理医疗中心（VAMC）的资源的收敛性可用性，以进行CABA的随机对照试验（RCT）。这项研究将招募192名OEF/OIF退伍军人，每个站点的96名参与者参加了被诊断为MTBI和PTSD的参与VAMC。 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脑震荡/MTBI并积极认可任何神经行为症状清单（NSI）认知症状项目（NSI）项目（项目13-17），4）英语，能够每周前往初级保健诊所进行10次课程，进行10次课程，并愿意进行后续评估，并避免在第一个3个月份的阶段进行阶段，如果他们在第一个3月3日的阶段进行了阶段，则该阶段是否有效。 5）愿意参加音频录制会议。排除标准将为1）当前的物质依赖性障碍，其禁欲少于30天，2）当前的双相或精神病障碍，3）主动自杀意图表明临床风险很大，4）在首次评估前的6周内开始精神药物； 4）听觉或视觉障碍将阻止参与认知康复组或从补偿策略中受益的能力。符合条件的参与者将像往常一样随机分配给CABA或治疗。 CABA组的参与者将在参与研究的前14周内接受CABA干预，而TAU参与者将继续在参与研究期间继续接受TAU（通常在PTSD特殊治疗诊所中的护理，但没有CABA）。两组将在基线，7周（中期），14周（治疗后）和39周（6个月后续时间）进行评估。在他们的研究参与期间，所有参与者将继续接受他们通常的医疗服务。