Background
The OPTIMIZE trial is a comparative effectiveness, multi-site randomized clinical trial with a Sequential Multiple Assessment Randomized Trial (SMART) design (Fig. Study design for the OPTIMIZE study, a Sequential Multiple Assessment Randomized Trial. CBT, cognitive behavioral therapy; MORE, Mindfulness-Oriented Recovery Enhancement; PT, physical therapy; R, randomizeEach treatment studied in the OPTIMIZE trial represents a complex health intervention (CHI) because each comprises multiple, interactive components that are implemented with flexibility in routine care and require behavioral changes by the person receiving the interventions [Modifications to evidence-based interventions, particularly those that occur during the execution of a clinical trial, should be comprehensively characterized and documented because of the impact on the interpretation of the study’s findings and future implementation efforts [