Intervening on fear after acute cardiac events: Rationale and design of the INFORM randomized clinical trial.

OBJECTIVE: Many acute coronary syndrome (ACS) patients are nonadherent to cardiovascular medications despite their known benefits for lowering risk of recurrent cardiovascular events. Research suggests that greater cardiac-related fear of recurrence (FoR) may be associated with higher nonadherence to cardiovascular medications and avoidance of physical activity. We aim to test the effect of an intervention that targets FoR as a potentially modifiable mechanism underlying nonadherence to recommended health behaviors among patients with suspected ACS. METHOD: The INFORM trial ("INvestigating Fear Of Recurrence as a modifiable Mechanism of behavior change to improve medication adherence in acute coronary syndrome patients") is a double-blind, parallel-group randomized clinical trial. It compares an 8-session, at-home, electronic tablet-delivered, cognitive bias modification training (CBMT) intervention with a sham control. Patients who experience high perceived threat at the time of presentation to the emergency department (ED) with a suspected ACS are enrolled and randomized within 6 weeks of their ED visit. The primary outcome, FoR, is measured by the adapted Concerns about Recurrent ACS Scale. The trial also tests the intervention's effect on a potential mechanism of health behavior change that is inversely correlated with fear: an expansive future time perspective. Additional outcomes include electronically measured adherence to a cardiovascular medication and self-reported physical activity. CONCLUSIONS: This study takes a mechanistic approach to addressing the dangerous problem of poor health behaviors after ACS. The trial will test whether targeting FoR or future time perspective by CBMT is a promising approach to improving nonadherence after ACS. (PsycInfo Database Record (c) 2020 APA, all rights reserved).