A Pragmatic Randomized Controlled Trial Investigating Work Enhanced Cognitive Behavioral Therapy for People with Serious Mental Illness (WORKWELL): Background, Design, and Baseline Outcomes

Background Employment is a powerful social determinant of health, and dysfunction in this area is pervasive among veterans with serious mental illness (SMI), despite implementation of evidence-based employment services by the US Department of Veterans Affairs. Recently, cognitive and behavioral work barriers have been identified. Objective The Cognitive Behavioral Therapy for Work Success intervention (CBTw) was developed, demonstrating early promise in improving work and psychosocial outcomes among Veterans with SMI. WORKWELL is a hybrid Type I, three site randomized controlled trial seeking to rigorously test the effectiveness and implementation of CBTw into VA employment services. Methods WORKWELL seeks to enroll 276 unemployed veterans with SMI receiving VA employment services, randomizing them to 12 weeks of group based CBTw or a psychoeducation control. Study interventions will be implemented by VA vocational rehabilitation counselors. Outcomes Measured at baseline, post-treatment, 6, 9, and 12 months, the primary Veteran outcome is competitive work. Secondary outcomes include health, psychosocial, and suicidality factors. Inpatient service utilization will be assessed, and exploratory employment outcomes will be measured at 12 months to capture outcomes that may take longer to emerge. Conclusions Guided by the RE-AIM framework, factors needed to rapidly implement CBTw across the VA will be captured.