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

Abstract

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.

Fear of Recurrence of Atrial Fibrillation: Translating a Cancer Fear Model to the Atrial Fibrillation Patient Experience

“…While this concept has yet to be translated to understanding the AF patient experience, both FoR models in cancer research and prior research regarding other well-defined cardiac-specific fears (e.g., ICD shock anxiety) have taken a two-factor approach to understanding patient fears–examining both fear of antecedents and consequences ( 28 , 29 ). Similarly, ( 30 ) have recently utilized a cancer model as a framework for understanding recurrence fears among patients following acute coronary syndromes (ACS). Birk and colleagues are currently examining its impact on medication adherence and physical activity engagement in a randomized trial targeting patients fears vs. usual care.…”

Toward an open mechanistic science of behavior change.

“…The 10 articles in this commentary illustrate the considerable breadth and depth of thought involved in conducting a robust mechanistic science of behavior change (Birk et al, 2020; Brewer, Roy, Deluty, Liu, & Hoge, 2020; Dong et al, 2020; Halbert et al, 2020; Leahey et al, 2020; Mackiewicz Seghete et al, 2020; McHugh, Nguyen, Fitzmaurice, & Dillon, 2020; Otto et al, 2020; Scioli et al, 2020; Wilson et al, 2020). There are a wide range of different populations being supported (e.g., patients with acute coronary syndrome, parent/adolescent dyads, African American women breast cancer survivors, adults experiencing opioid use disorder), intervention strategies (e.g., mindfulness, delay discounting tasks, affect labeling, exercise), mechanisms (e.g., fear of recurrence, delay discounting, stress reactivity, neuropeptide Y, self-regulation), and behaviors/health outcomes (e.g., physical activity, sleep, worry, medication adherence).…”

“…For example, many articles build on foundational operant and classical conditioning perspectives in framing the temporal dynamics as a series of learning trials with competing learning processes at different temporal scales. This is particularly well-illustrated in the design used to understand cognitive bias training to reduce fear of recurrence among individuals with acute coronary syndrome conducted by Birk and colleagues (2020). Dong et al (2020), meanwhile, postulated the importance of each interaction between parents and adolescents, with subtle dyad interactions facilitating positive conversational behaviors, reduced conflict, and, eventually, improved motivation to improve sleep.…”

“…For example, Brewer et al (2020), Otto et al (2020), and Mackiewicz Seghete’s et al (2020) articles all advance mindfulness interventions but with different intervention operations and hypotheses postulated for each (in part as each is focused on distinct populations and different targeted mechanisms). In terms of control conditions, while many researchers chose a treatment-as-usual or similar clinical variant, others, such as Birk et al (2020), chose very tight mechanistic-oriented control conditions, with that research group going so far as to include a sham control condition for their theorized mechanism of cognitive bias modification. Notably, several articles (i.e., Halbert et al, 2020; Mackiewicz Seghete et al, 2020; McHugh et al, 2020; Otto et al, 2020) use a mixture of physiological, cognitive testing, and/or self-report measures to study interrelated mechanisms, including the use of laboratory-based manipulations to study issues like stress-reactivity.…”

Future directions of the National Institutes of Health Science of Behavior Change Program

“…SOBC-funded projects have used an experimental medicine approach to investigate a variety of mechanistic targets and health behaviors across the domains of self-regulation, interpersonal and social processes, and stress resilience and stress reactivity, with links to health outcomes relevant to multiple NIH Institutes and Centers. These health outcomes include, for example, cardiovascular health [ 7 , 8 ], sleep health [ 9 ], stress and physical activity [ 10 ], opioid use disorder [ 11 ], obesity [ 12–14 ], prediabetes and diabetes management [ 15 , 16 ], smoking cessation [ 17 ], and breast cancer survivorship among African American women [ 18 ]. Two areas of research not addressed by current SOBC-funded projects provide promising opportunities to apply a mechanisms-focused approach to behavior change research: reproductive health and COVID-19 vaccine uptake.…”