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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 294
- 试验地点
- 3
- 主要终点
- Total Weeks Worked in Competitive Jobs
研究概览
简要总结
Vocational instability in Veterans with serious mental illness (SMI) is pervasive, costly, and harmful. Over 75% of Veterans with SMI are unemployed, resulting in economic difficulties and trouble meeting basic needs. Overall, among adults with depression, work dysfunction results in a 36 to 51 billion dollar loss annually. Unemployed Veterans with SMI also suffer major health consequences, including a more severe course of illness and poor recovery over time, leading to increased inpatient and emergency service use. The WORKWELL study will synergistically address these deficits in health, recovery, and work functioning by testing the Cognitive Behavioral Therapy for Work Success (CBTw) intervention. Using a pragmatic design, this project will address work as a major social determinant of health and close the health disparity gap among people with SMI. Further, through promotion of work and healthy thinking, CBTw holds promise to reduce risk of suicide among vulnerable veterans with SMI.
详细描述
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 12-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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Research personnel conducting outcomes assessments will be blinded to condition assignment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unemployment, defined as no current participation in a competitive job
- •A competitive work goal, which denotes a goal of a regular job in the community that pays at least minimum wage
- •Presence of a serious mental illness including one or more of the following conditions:
- •major depression
- •bipolar disorders
- •schizophrenia
- •schizoaffective disorder
- •posttraumatic stress disorder (PTSD)
- •Currently enrolled in and receiving VA vocational rehabilitation services
排除标准
- •Previous participation in cognitive behavioral therapy intervention geared toward work
- •Presence of a severe medical or cognitive impairment that will prevent participation in the study
结局指标
主要结局
Total Weeks Worked in Competitive Jobs
时间窗: Baseline to 3 months
Mean number of weeks worked in competitive jobs. Competitive jobs are regular jobs open to all that pay at least minimum wage. More total weeks worked in competitive jobs is indicative of a positive outcome.
Total Weeks Worked in Competitive Jobs
时间窗: 3 to 6 Months
Mean number of weeks worked in competitive jobs.
Total Weeks Worked in Competitive Jobs
时间窗: 6 to 9 months
Mean number of weeks worked in competitive jobs.
次要结局
- Short Employment Hope Scale (EHS-14)(baseline to 9 months)
- Recovery Assessment Scale (RAS)(baseline to 9 months)
- Scale for Suicidal Ideation Change(baseline to 9 months)
- Cognitive Behavioral Therapy for Work Success (CBTw) Fidelity(12 weeks (during the CBTw intervention period))