Work as a determinant of health: A pragmatic trial of enhanced cognitive behavioral therapy to bolster competitive work and wellness in veterans with serious mental illness (WORKWELL)

项目背景：工作是健康的主要社会决定因素。在患有严重精神疾病的人中 (SMI)工作与更好的福祉、身心健康、生活质量有关， 预防残疾的发生。在患有SMI的退伍军人中，工作是防止自杀的保护因素。 大多数患有SMI的退伍军人失业，健康状况和恢复状况都很差 在关键领域。尽管有高质量的VHA职业服务，如支持性就业， 接受这些服务的退伍军人中有三分之二或更多的人经历了工作障碍。一个可能 解释在于未解决的认知和行为障碍，如与工作相关的低自我效能， 缺乏有效的应对技能，对工作的实现不抱希望，工作动力和自我意识差。 工作成功的认知行为疗法（CBTw）干预旨在 针对这些问题，增加VHA SE服务，以协同改善工作和健康 和恢复，在退伍军人与SMI。在一项开放试验中，CBTw与显著性相关， 工作时间和工资收入增加，大多数CBTw参与者变得稳定 工人退伍军人也经历了症状，恢复和生活质量的改善。 项目目标：采用Hybrid 1 RCT设计，本项目将测试CBTw对竞争性工作的影响 以及在3个VA SE项目中为期9个月的研究期间的健康和恢复结果。通知 RE-AIM框架，实施评估将检查使用SE员工交付的成功情况 CBTw，执行的障碍和促进因素，以及使用的战略。 与优先事项的相关性：该项目具有很高的实施潜力，并对VHA做出响应 优先考虑健康公平，因为它将解决工作功能问题，这是一个研究不足的社会决定因素 of health. WORKWELL还承诺改善退伍军人的健康和恢复结果 SMI是HSR&D的另一个重点领域。最后，本研究的目的是发现 在脆弱的退伍军人群体中预防自杀的新策略，包括那些患有SMI的人。 目的：目的1：测试CBTw + SE与心理教育+ SE对照相比对以下方面的影响： 工作假设：CBTw+ SE组的参与者将在 有竞争力的工作（主要研究结果），更有可能成为稳定的工人。 目的2：测试CBTw + SE对健康和恢复的影响。假设：CBTw +的参与者 SE组在主观恢复和健康相关生活质量方面的改善更大， 减少症状、自杀意念和住院服务利用。 目标3：在RE-AIM实施科学框架的指导下， 推行社区工作队，包括研究由社会企业人员推行社区工作队的可行性，以及 相关的障碍和促进因素。目标是促进未来大规模实施CBTw。 项目方法：WORKWELL是一个实用的混合1设计RCT。CBTw将在3 SE进行测试 地点-Roudebush VA医疗中心、Edward J. Hines VA医疗中心和VA圣路易斯 卫生保健系统。276名患有SMI的失业退伍军人将被随机分配接受CBTw 或心理教育加SE的对照。结果，包括总工作周数 竞争性工作（主要），实现稳定的工作，症状，恢复，健康相关的质量 将在治疗后（12周）、6个月、 （主要终点）和9个月（检查持续效应）。CBTw实施规划， 将提供培训和咨询。CBTw的实施（忠实度）、障碍和促进因素 实施和其他RE-AIM元素将使用混合方法进行检查。

Project background: Work is a major social determinant of health. In people with serious mental illness (SMI), work is associated with better wellbeing, physical and mental health, quality of life, and may prevent the onset of disability. Among Veterans with SMI, work is a protective factor against suicide. Most veterans with SMI are unemployed and suffer substantially worse health and recovery across key domains. Despite quality VHA vocational services, such as supported employment (SE), two-thirds or more of veterans who receive these services experience work dysfunction. A probable explanation lies in unsolved cognitive and behavioral barriers, such as low work-related self-efficacy, ineffective coping skills, little hope that work is attainable, poor work motivation and sense of self. The Cognitive Behavioral Therapy for Work Success (CBTw) intervention was designed to target these problems and augment VHA SE services to synergistically improve work, as well as health and recovery, in Veterans with SMI. In an open trial pilot, CBTw was associated with significant increases in hours worked and wages earned and the majority of CBTw participants became steady workers. Veterans also experienced improvements in symptoms, recovery, and quality of life. Project goals: Using Hybrid 1 RCT design, this project will test the effects of CBTw on competitive work and health and recovery outcomes over a 9-month study period at 3 VA SE programs. Informed by the RE-AIM framework, an implementation evaluation will examine the success of using SE staff to deliver CBTw, barriers and facilitators to implementation, and strategies utilized. Relevance to priorities: This project has high implementation potential and is responsive to the VHA priority regarding Health Equity, as it will address work functioning, an under studied social determinant of health. WORKWELL also holds promise to improve health and recovery outcomes among Veterans with SMI, another HSR&D area of emphasis. Lastly, this study is consistent with the goal of finding novel strategies toward suicide prevention among vulnerable Veteran groups, including those with SMI. Objectives: Aim 1: Test the effects of CBTw + SE compared to a control of psychoeducation + SE on work. Hypotheses: Participants in the CBTw+ SE arm will work significantly more total weeks in competitive jobs (primary study outcome) and will be more likely to become steady workers. Aim 2: Test the effects of CBTw + SE on health and recovery. Hypotheses: Participants in the CBTw + SE arm will have greater improvements on subjective recovery and health-related quality of life, and decreases in symptoms, suicidal ideation, and inpatient service utilization. Aim 3: Guided by the RE-AIM implementation science framework, conduct an evaluation of the implementation of CBTw, including examination of the feasibility of using SE staff to deliver CBTw, and related barriers and facilitators. The objective is to spur future wide scale CBTw implementation. Project Methods: WORKWELL is a pragmatic, Hybrid 1 design RCT. CBTw will be tested at 3 SE sites—Roudebush VA Medical Center, the Edward J. Hines VA Medical Center, and the VA St. Louis Health Care System. 276 unemployed Veterans with SMI will be randomly assigned to receive CBTw plus SE or a control of psychoeducation plus SE. Outcomes including total weeks worked in competitive jobs (primary), achievement of steady work, symptoms, recovery, health related quality of life, suicidal ideation, and service utilization will be assessed at posttreatment (12 weeks), 6 months (primary endpoint), and 9 months (to examine sustained effects). CBTw implementation planning, training, and consultation will be provided. CBTw implementation (fidelity), barriers and facilitators to implementation, and other RE-AIM elements will be examined using mixed methods.