A Feasibility Study of Behavioral Activation in the Rehabilitation of Veterans with Post-TBI Depression

自2000年以来，已有近40万退伍军人被诊断为创伤性脑损伤(TBI)，这代表了 高达22%的战斗伤亡。抑郁症是颅脑损伤后遗症中最常见、最严重的后遗症之一。邮寄- TBI抑郁对康复、治疗依从性、重新融入社区(CR)、 生活质量(QOL)、社会关系和照顾者负担。然而，创伤性脑损伤后的抑郁症仍然被低估， 没有得到充分的对待，没有得到充分的研究。目前尚无脑外伤后抑郁治疗的临床指南 治疗很大程度上是基于专家的意见，而不是来自对照临床试验的证据。 行为激活(BA)是治疗脑外伤后抑郁的一种有前途的方法，它是一种简短和 自20世纪70年代以来在不同临床试验中对抑郁症进行了严格的务实治疗 人口。BA可以适应TBI的标志性缺陷，如记忆、组织 计划、启动、情绪调节和人际功能。它可以由专业人员递送 在退伍军人管理局门诊康复服务中常规提供(例如，职业治疗师、护士、 心理学家、社会工作者)，因此可以部署在康复环境中。建议数 研究将评估适用于颅脑损伤后抑郁的VA门诊患者BA方案的可行性 康复环境。具体的研究目标是：(1)评估退伍军人和员工对BA的接受程度，以及 其他可行性指数，(2)提供参与者对#年成果作出反应的初步证据 在3个月的随访中，抑郁症状、CR和生活质量，(3)制定BA方案和 手册将在未来的更大规模随机对照试验(RCT)中进行测试，以及(4)探索参与 活动作为BA干预效果的基础机制对结果产生影响。 这项可行性研究将招募40名在VAMC康复中心接受护理的男性和女性退伍军人 医疗服务和符合脑外伤和抑郁症的研究标准。退伍军人将随机分配到BA 加常规治疗(TAU)或对照(TAU)。文学士课程由6个课程组成，分3节授课 在退伍军人管理局(或退伍军人之家，如果愿意)由职业治疗师(OT)治疗数月。所有退伍军人都是 在随机前和3个月后，由盲人面试者在基线上进行采访。两次采访 使用标准化工具评估退伍军人的抑郁症状、CR和QOL。可行性将是 根据退伍军人和诊所工作人员的可接受性、流程变量(例如，保留、研究)进行评估 完成率)、安全性、资格标准的充分性、参与者理解程度和研究负担， 使用先验的成功标准。最后，将与广管局的参与者和工作人员进行电话访问，以 捕捉他们与英国航空公司的经验。这些定性和定量方法旨在测试 未来区域康复评估的可行性，以确定在康复中实施BA的障碍和促进者 环境，并描述患者的经历和与BA的接触。 这项研究计划有可能通过确定一个可行和有效的 预防和/或减轻退伍军人脑外伤患者抑郁的方法 治疗抑郁症及其后遗症。研究结果将被用来为未来RCT的发展提供信息 有能力在更大样本的患有脑外伤后抑郁症的退伍军人中测试BA的疗效。 这项研究解决了旨在提高参与度的干预研究的RR&D优先事项 有心理健康问题的退伍军人协会。如果BA被证明是可行和有效的， 研究将为康复服务增加一个重要的临床工具，可能会减少或预防抑郁症。 缓解抑郁反过来应该促进康复努力并提高CR，使退伍军人能够 在社会中发挥更充分的作用。

Nearly 400,000 Veterans have been diagnosed with traumatic brain injury (TBI) since 2000, representing up to 22% of combat casualties. Depression is one of the most prevalent and serious of TBI sequelae. Post- TBI depression adversely affects rehabilitation, treatment adherence, community reintegration (CR), quality of life (QOL), social relationships, and caregiver burden. Yet, post-TBI depression remains under-assessed, undertreated, and under-studied. No clinical guidelines for post-TBI depression treatment exist, and current treatment is largely based on expert opinion rather than evidence from controlled clinical trials. A promising therapeutic approach to post-TBI depression is Behavioral Activation (BA), a brief and pragmatic treatment rigorously tested since the 1970s in clinical trials for depression in diverse clinical populations. BA can accommodate hallmark deficits of TBI such as deficits in memory, organization, planning, initiation, emotion regulation, and interpersonal functioning. It can be delivered by professionals routinely available in VA outpatient rehabilitation services (e.g., occupational therapists, nurses, psychologists, social workers) and, therefore, can be deployed in rehabilitation settings. The proposed research will assess the feasibility of a BA protocol adapted for post-TBI depression in an outpatient VA rehabilitation setting. Specific study objectives are to: (1) assess BA's acceptability to veterans and staff and other feasibility indices, (2) provide preliminary evidence of participant response in the outcomes of depressive symptoms, CR, and QOL at the 3-month follow-up interview, (3) develop the BA protocol and manual to be tested in a larger randomized controlled trial (RCT) in the future, and (4) explore engagement in activity as the mechanism that underlies BA intervention effects on outcomes. This feasibility study will enroll 40 male and female veterans receiving care at a VAMC Rehabilitation Medicine Service and meeting study criteria for TBI and depression. Veterans will be randomly assigned to BA plus treatment as usual (TAU) or control (TAU). The BA program consists of six sessions delivered over 3 months at the VA (or veterans' homes, if preferred) by an occupational therapist (OT). All veterans are interviewed at baseline before randomization and 3 months later by a blinded interviewer. Both interviews assess veterans' depressive symptoms, CR, and QOL, using standardized instruments. Feasibility will be evaluated in terms of acceptability to veterans and clinic staff, process variables (e.g., retention, study completion rates), safety, adequacy of eligibility criteria, participant comprehension, and research burden, using a priori criteria for success. Finally, phone interviews with BA participants and staff will be conducted to capture their experience with BA. These qualitative and quantitative methods are designed to test the feasibility of a future RCT, to identify the barriers and facilitators to implementation of BA in the rehabilitation setting, and to describe patients' experiences and engagement with BA. This research program has the potential to advance knowledge by identifying a feasible and efficacious approach to preventing and/or mitigating depression among veterans with TBI, a clinical population at high risk for depression and its sequelae. Study findings will be used to inform the development of a future RCT powered to test BA's efficacy in a larger sample of veterans with post-TBI depression. The research addresses RR&D priorities for research on interventions aiming to improve participation in society for veterans with psychological health conditions. If BA is shown to be feasible and efficacious, the research will add an important clinical tool to rehabilitation services that may reduce or prevent depression. Mitigating depression should in turn facilitate rehabilitation efforts and enhance CR, allowing the veteran to function more fully in society.