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: 10517278
• 负责人: Megan L Callahan
• 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 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10517278
• 关键词: Abstinence; Address; Afghanistan; Aftercare; Auditory; Awareness; Behavioral; Bipolar Disorder; Caring; Characteristics; Clinic; Clinical; Clinical Practice Guideline; Cognitive; Conflict (Psychology); Craniocerebral Trauma; Diagnosis; Disease; Effect Modifiers (Epidemiology); Elements; Enrollment; Equipment and supply inventories; Etiology; Evaluation; Event; Evidence based treatment; Exclusion Criteria; Exhibits; Freedom; Goals; Healthcare; Hybrids; Impairment; 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; 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; Veterans Health Administration; Visual impairment; Walkers; War; Washington; associated symptom; base; clinical effect; clinical risk; cognitive function; cognitive rehabilitation; combat; comorbidity; daily functioning; depressive symptoms; design; effective therapy; effectiveness evaluation; efficacy evaluation; eligible participant; evidence base; follow up assessment; follow-up; functional disability; holistic approach; improved; inclusion criteria; medical specialties; member; mild traumatic brain injury; neuropsychiatric symptom; operation; performance tests; prevent; public health relevance; randomized controlled design; recruit; satisfaction; secondary outcome; suicidal; therapy design; treatment as usual; willingness; wound

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）： 从伊拉克和阿富汗当前冲突返回的退伍军人表现出较高的 mTBI/PTSD 共病率。鉴于这些疾病的共病和神经精神症状重叠，可能很难确定功能问题和功能障碍是否是由 mTBI、PTSD 或两者引起的。因此，对于医疗服务提供者来说，了解如何优先考虑这些患者的临床问题以及如何有效地治疗这些问题是一项挑战。目前，尚无针对共病 mTBI/PTSD 的循证治疗方法。此外，目前还不清楚每种疾病的现有治疗方法在多大程度上可以在另一种疾病上坚持有效地实施。因此，目前大多数的治疗建议都建议采用整体或综合的方法来治疗共病 mTBI/PTSD，目标是症状和功能，而不是潜在的病因。我们正在提议一种针对共病 mTBI 和 PTSD 的治疗方法，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，这是一种新的混合疗法，适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 是否可以减轻患有 mTBI/PTSD 的退伍军人的 PTSD 症状，2) CABA 可以减轻患有 mTBI/PTSD 的退伍军人的认知相关功能障碍，3) CABA 可以改善抑郁症状、认知功能以及患有 mTBI/PTSD 的退伍军人的生活质量； 4) 对于患有 mTBI/PTSD 的退伍军人来说，CABA 是一种可接受的治疗方法。总体目标是开发一种针对共病 mTBI/PTSD 的循证手动治疗方法，该治疗方法可以在退伍军人健康管理局 (VHA) 治疗环境中轻松实施。该研究设计利用俄勒冈州波特兰和华盛顿州西雅图两个参与的退伍军人管理局医疗中心 (VAMC) 的资源聚合来进行 CABA 随机对照试验 (RCT)。该研究将总共招募 192 名 OEF/OIF 退伍军人，每个地点 96 名参与者，在参与的 VAMC 中登记，他们被诊断患有 mTBI 和 PTSD。纳入标准为 1) 在参与 VA 站点之一注册的 OIF/OEF 时代退伍军人，他们能够提供知情同意书，2) 根据临床医生管理的 PTSD 量表诊断 PTSD（Blake 等人，1990），3)根据 VA/DoD 脑震荡/mTBI 管理临床实践指南，对收集头部创伤事件特征的结构化访谈进行积极筛选积极认可任何神经行为症状量表 (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进行 10 次治疗并进行后续评估，并且愿意避免如果他们被分配到 CABA 状况，则从治疗活跃阶段的前 3 1/2 个月开始额外的心理健康治疗，以及 5) 参与的意愿录音会议。排除标准为 1) 目前有物质依赖障碍，且戒断时间少于 30 天；2) 目前患有双相情感障碍或精神障碍；3) 有自杀倾向，表明存在重大临床风险；4) 在第一次评估前 6 周内开始服用精神药物； 4) 听觉或视觉障碍会妨碍参加认知康复小组或从补偿策略中受益。符合条件的参与者将被随机分配到 CABA 组或照常治疗 (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，但不接受 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）时接受评估。在研究参与期间，所有参与者将继续接受通常的医疗护理。