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。患有严重精神疾病的人 (SMI)，工作与更好的幸福感、身心健康、生活质量有关，而且可能 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的退伍军人都失业了，健康状况和康复情况都糟糕得多 跨关键领域。尽管VHA提供了优质的职业服务，如辅助就业(SE)， 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。一个可能的 原因在于未解决的认知和行为障碍，如与工作有关的自我效能感低， 应对能力不强，工作可望而不可及，工作动力和自我意识不强。 工作成功认知行为疗法(CBTw)干预旨在 针对这些问题并增强VHA SE服务，以协同改进工作和健康 和康复，在患有SMI的退伍军人中。在一项公开试验中，CBTw与显著的 工作时间和工资增加，大多数CBTW参与者变得稳定 工人们。退伍军人在症状、康复和生活质量方面也有所改善。 项目目标：使用混合1随机对照试验设计，该项目将测试CBTw对竞争性工作的影响 以及在3个VA SE项目的9个月研究期内的健康和恢复结果。由 Re-AIM框架，实施评估将检查使用SE员工交付的成功 CBTw，执行的障碍和促进者，以及所采用的战略。 与优先事项的相关性：该项目具有很高的实施潜力，并对VHA作出反应 关于健康公平的优先事项，因为它将解决工作运作问题，这是一个正在研究的社会决定因素 关于健康的。WorkWell还承诺改善退伍军人的健康和康复结果 SMI是高铁研发的另一个重点领域。最后，本研究与本文的研究目标是一致的。 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的群体。 目的：目的1：测试CBTw+SE与心理教育+SE对照的效果 工作。假设：CBTw+SE ARM的参与者在未来几周的工作时间将显著增加 有竞争力的工作(主要研究结果)，将更有可能成为稳定的员工。 目的2：测试CBTw+SE对健康和康复的影响。假设：CBTw+的参与者 SE ARM在主观康复和与健康相关的生活质量方面将有更大的改善，以及 症状、自杀意念和住院服务利用率下降。 目标3：在RE-AIM实施科学框架的指导下，对 实施CBTw，包括审查使用SE人员交付CBTw的可行性，以及 相关障碍和促进者。其目标是促进未来大规模的CBTw的实施。 项目方法：WorkWell是一个务实、混合的设计RCT。CBTw将在3 SE进行测试 地点-罗德布什退伍军人医疗中心、爱德华·J·海因斯退伍军人医疗中心和退伍军人事务部圣路易斯 医疗保健系统。276名患有SMI的失业退伍军人将被随机分配到CBTw 加自闭症或对照心理教育加自闭症。结果，包括工作周总数 竞争性工作(主要)、稳定工作的成就、症状、康复、与健康相关的质量 将在治疗后(12周)、6个月内评估生命、自杀意念和服务利用情况 (主要终点)和9个月(检查持续效果)。CBTw实施规划， 将提供培训和咨询。CBTw实施(保真度)、障碍和促进者 将使用混合方法审查RE-AIM的其他要素。

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.