NCT Number: NCT04504903
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Edward Hines Jr. VA Hospital, Hines, IL, Hines, Illinois, United States
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.
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). Primary work outcomes will be collected monthly over a 12-month period. 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Veterans will go to 12 weekly group sessions and will learn healthy thinking about work, positive behavioral coping related to work, and will form a work success plan based on their work goals.
Veterans will go to 12 weekly group sessions and will learn more information about their mental health conditions. Psychoeducation modules are from the Illness Management and Recovery program.
Time frame: 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.
Time frame: 3 to 6 Months
Mean number of weeks worked in competitive jobs.
Time frame: 6 to 9 months
Mean number of weeks worked in competitive jobs.
Time frame: baseline to 9 months
The Short Employment Hope Scale (EHS-14) measures employment hope, defined as the psychological construct characterized by possession of work-related empowerment and motivation for the future, envisionment of meaningful and satisfying employment, job-based goal orientation, and progress toward employment using skills and resources. The EHS-14 is comprised of two subscales-Psychological Empowerment and Goal-oriented pathways (7 items each). The EHS-14 is made up of a total of 14 items scored on a 0 (minimum) to 10 (maximum) scale with total scores comprised of a mean of all 14 items. Higher scores indicate better (increased) employment hope and lower scores indicate worse (decreased) employment hope.
Time frame: baseline to 9 months
The Recovery Assessment Scale (RAS) measures subjective mental health recovery. The RAS consists of 41 items and an overall score is calculated using a mean of all items, with scores ranging from 1 (maximum) to 5 (minimum). Higher RAS scores indicate better (increased) subjective recovery with lower RAS scores indicating worse (decreased) subjective recovery. This outcome was only examined for patient participants and not for provider participants arm.
Time frame: baseline to 9 months
Outcome measure is a 21-item interviewer rated measure of a continuum of suicidal ideation, including thoughts, attitudes, plans, and behaviors. Total scores range from 0 to 42 with higher scores indicating more suicidal ideation.
Time frame: 12 weeks (during the CBTw intervention period)
Fidelity to the Cognitive Behavioral Therapy for Work Success (CBTw) model was measured using the Cognitive Therapy Scale-Revised. The Cognitive Therapy Scale-Revised is comprised of 8 items gauging core components of the CBTw intervention and overall fidelity is measured as a mean of the 8 items. Total fidelity scores range from 0 (minimum) to 6 (maximum) with higher scores indicating greater adherence and proficiency to the CBTw model. Scores of 3 or higher indicate adequate fidelity in which the CBTw intervention is considered delivered as intended. Fidelity was only measured for provider participants and was not measured for participants in the Cognitive Behavioral Therapy for Work Success and Psychoeducation arms.
VA Office of Research and Development
Fed
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)
Acronym: WORKWELL
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