Contextual modifications
CHIs
The modification to resolve the issue of changes to in-person delivery was to deliver CHIs to OPTIMIZE participants using the delivery format (in-person or telehealth) that was predominant in the health system at the time of enrollment. For example, a patient enrolled and randomized to PT in phase I would be recommended to attend in-person PT if at least half of the PT sessions were being provided in person in the health care system at the time. The same modification applied to the other CHIs in the study and to phase II assignments. Similar to many health care delivery settings, after the initial weeks of the COVID pandemic, behavioral health providers, who deliver CBT and MORE, continued to predominantly use telehealth, while PT providers largely resumed in-person care [The modification to allow telehealth delivery of some CHIs required the ability to participate in telehealth be added as a criterion for eligibility to participate in the OPTIMIZE study. The number of persons unable to participate due to this criterion was added to the study’s tracking of screening procedures so that the number of persons unable to participate for this reason is documented. The study’s single IRB approved these changes to permit the resumption of enrollment into the study.