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

行为激活在患有 TBI 后抑郁症的退伍军人康复中的可行性研究

• 批准号: 10250799
• 负责人: Helene Joy Moriarty
• 金额: --
• 依托单位: PHILADELPHIA VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10250799
• 关键词: Address; Adherence; Affect; Antidepressive Agents; Behavioral; Behavioral trial; Blinded; Caregiver Burden; Caring; Clinic; Clinical; Clinical Trials; Cognitive; Cognitive Therapy; Comprehension; Control Groups; Controlled Clinical Trials; Data; Development; Diagnosis; Eligibility Determination; Employment Status; Enrollment; Executive Dysfunction; Expert Opinion; Fatigue; Feasibility Studies; Female; Functional disorder; Funding; Future; Goals; Guidelines; Health Professional; Health system; Home; Improve Access; Individual; Injury; Insurance; Intervention; Interview; Interviewer; Knowledge; Length; Manuals; Measures; Mediating; Mediator of activation protein; Medical; Memory; Mental Depression; Mental Health; Methods; Monitor; Nurses; Occupational Therapist; Outcome; Outpatients; Pain; Participant; Patients; Persons; Pharmaceutical Preparations; Physical Function; Physical Medicine; Plant Roots; Population; Post-Traumatic Stress Disorders; Process; Protocols documentation; Provider; Psychologist; Quality of life; Randomized; Randomized Controlled Trials; Rehabilitation therapy; Research; Research Personnel; Research Priority; Resources; Rewards; Role; Safety; Sampling; Schedule; Services; Severities; Social Workers; Social isolation; Societies; Standardization; Symptoms; Telephone; Testing; Therapeutic; Training; Traumatic Brain Injury; Treatment Protocols; United States National Institutes of Health; Veterans; War; Work; base; behavior test; behavioral study; clinically significant; combat casualty; community reintegration; depressive symptoms; design; efficacy trial; emotion dysregulation; emotion regulation; emotional distress; executive function; experience; experimental arm; feasibility testing; follow-up; high risk; implementation design; improved; indexing; instrument; intervention effect; male; meetings; military veteran; poor communities; post intervention; prevent; primary outcome; programs; recruit; rehabilitation service; rehabilitative care; response; retention rate; secondary outcome; service member; side effect; social; social relationships; success; suicidal risk; therapy design; tool; treatment adherence; treatment as usual; treatment effect; treatment response; uptake

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.

自2000年以来，近40万退伍军人被诊断患有创伤性脑损伤（TBI）， 高达22%的战斗伤亡抑郁症是脑外伤后遗症中最普遍、最严重的症状之一。后 TBI抑郁症对康复、治疗依从性、社区重返社会（CR）、治疗质量 生活（QOL），社会关系和照顾者负担。然而，TBI后抑郁症仍然被低估， 治疗不足，研究不足目前还没有针对TBI后抑郁症治疗的临床指南， 治疗主要基于专家意见，而不是来自对照临床试验的证据。 TBI后抑郁症的一种有前途的治疗方法是行为激活（BA），一种简短而有效的方法。 自20世纪70年代以来，务实的治疗方法在各种临床试验中对抑郁症进行了严格的测试。 人口。BA可以适应TBI的标志性缺陷，例如记忆、组织、 计划、启动、情绪调节和人际功能。它可以由专业人士提供 VA门诊康复服务中常规可用的（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机构。拟议 研究将评估适用于门诊VA患者TBI后抑郁的BA方案的可行性 康复环境。具体的研究目标是：（1）评估BA对退伍军人和工作人员的可接受性， 其他可行性指数，（2）提供参与者对 3个月随访时的抑郁症状、CR和QOL，（3）制定BA方案， 手册将在未来更大的随机对照试验（RCT）中进行测试，以及（4）探索参与 活动的机制，基础BA干预效果的结果。 这项可行性研究将招募40名在VAMC康复中心接受护理的男女退伍军人。 符合TBI和抑郁症的研究标准。退伍军人将被随机分配到BA 加常规治疗（TAU）或对照（TAU）。BA课程包括6个会议， 在退伍军人事务部（或退伍军人之家，如果喜欢）由职业治疗师（OT）。所有退伍军人都是 在随机化前的基线和3个月后由盲法访谈者进行访谈。两次面谈 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，过程变量（例如，研究保留 完成率）、安全性、合格标准的充分性、参与者理解和研究负担， 使用先验的成功标准。最后，我们会与广管局的参与者及员工进行电话访问， 捕捉他们在BA的经验。这些定性和定量方法旨在测试 未来RCT的可行性，以确定在康复中实施BA的障碍和促进因素 设置，并描述患者的经验和参与BA。 这项研究计划有可能通过确定一个可行的和有效的 预防和/或减轻创伤性脑损伤退伍军人抑郁症的方法，临床高危人群 治疗抑郁症及其后遗症研究结果将用于为未来RCT的开发提供信息 测试BA在更大样本的TBI后抑郁症退伍军人中的疗效。 这项研究涉及旨在改善参与生殖健康和发展的干预措施研究的优先事项， 心理健康问题退伍军人协会。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，可能减少或预防抑郁症。 减轻抑郁症应该反过来促进康复工作，提高CR，使退伍军人， 在社会中发挥更大的作用。