Feasibility of a remote heart rate variability biofeedback intervention for reducing anxiety in cardiac arrest survivors: A pilot trial.

Background: Heart rate variability biofeedback (HRVB) is a promising non-pharmacologic approach for reducing anxiety. This intervention's feasibility needs testing in psychologically distressed cardiac patients for whom heart-related anxiety is a core concern. To enhance scalability and convenience, remote delivery of HRVB also needs to be assessed. Accordingly, we evaluated the feasibility of remote HRVB in survivors of cardiac arrest (CA) with elevated CA-related psychological distress. Methods: The intervention was comprised of daily sessions of diaphragmatic paced breathing and real-time monitoring of cardiac activity guided by a smartphone app and heart rate monitor. This single-arm feasibility trial assessed the percentage of eligible contacted patients who consented and engaged in the study and the self-reported acceptability, feasibility, appropriateness, and usability of the intervention. Exploratory analyses assessed pre-to-post changes in trait anxiety, negative affect, cardiac-related interoceptive fear, and resting-state HRV. Results: Of 12 eligible CA survivors contacted, 10 enrolled. All 10 patients completed the virtual study visits and the majority (>50 %) of prescribed training sessions. Ninety percent reported good scores for intervention acceptability and feasibility, and 80 % reported good scores for its appropriateness and usability for reducing fear. Trait anxiety decreased significantly pre-to-post intervention. There were no changes in negative affect, interoceptive fear, or resting state HRV. Conclusion: A remotely delivered HRVB intervention was acceptable, feasible, and useable for cardiac patients with CA-related psychological distress. A phase 2 randomized controlled trial evaluating the efficacy of HRVB on cardiac patients' psychological distress, health behaviors, and autonomic dysfunction may be warranted.

Home-based cognitive bias modification training for reducing maladaptive fear in patients with suspected acute coronary syndrome: a pilot randomized clinical trial.

BACKGROUND: Patients evaluated in an emergency department for suspected acute coronary syndromes (ACS; e.g., myocardial infarction) often experience a lingering fear of recurrence, which may adversely affect their mental health and adherence to recommended health behaviors. Cognitive bias modification training (CBMT) is an acceptable, easy-to-use intervention that reduces fear of recurrence in cancer patients, and reduces fear and anxiety in other populations, providing an alternative to psychotherapy or counseling-based approaches. Feasibility testing is needed to assess whether a cardiac-related version of CBMT is acceptable to patients with elevated threat perceptions related to their suspected ACS. METHODS: We developed a tablet-based CBMT intervention tailored to reduce cardiac-related fear of recurrence. In this double-blinded feasibility trial, patients with elevated threat perceptions related to a recent suspected ACS were randomized either to a 4-week, 8-session, tablet-delivered intervention (CBMT) group or to a sham attention control group. Feasibility outcomes included the proportion of eligible patients who enrolled, drop-out rate, intervention compliance rate, acceptability/pleasantness and usability ratings, and task engagement (i.e., accuracy, response time). RESULTS: Of 49 eligible patients with suspected ACS and elevated threat perceptions recruited from NewYork-Presbyterian Hospital, over half (53.1%) enrolled after receiving a description of study procedures. Of the 26 randomized patients (mean age 59.15 years, 50% women), 2 patients (7.7%) dropped out. Additionally, 4 (15.4%) enrolled patients were not able to complete the tablet tasks, either due to difficulties with the technology or an inability to process the visually presented linguistic information at a sufficient speed. Still, among patients who returned the tablets (19 returned/20 received; 95%), most completed all assigned tablet tasks (intervention or control; 10/19; 52.6%), reporting that the tablets were easy to use and that the tasks were pleasant to complete. CONCLUSION: Current findings suggest that cardiac-related CBMT is a promising and generally acceptable intervention for suspected ACS patients with cardiac-related threat perceptions which are akin to fear of recurrence. Nevertheless, challenges related to tablet usage indicate that the intervention user-experience should be further refined to optimize usability. TRIAL REGISTRATION: Registered at ClinicalTrials.gov on 2/25/2019; NCT03853213. Registered with the Open Science Framework on 11/20/2017; https://osf.io/k7g8c/ .

Family-authored ICU diaries to reduce fear in patients experiencing a cardiac arrest (FAID fear): A pilot randomized controlled trial.

Survivors of cardiac arrest (CA) and their family members often experience significant fear-based distress (cardiac fear; i.e., fear about the CA survivor's heart). Fear-based distress after CA is associated with higher rates of cardiac event recurrence and mortality in CA survivors. As posited in Dyadic Disruption Theory (DDT), cardiac fear in family members may contribute to the development of distress in CA survivors via socially-based mechanisms. Thus, interventions to reduce family distress may improve CA survivors' outcomes. ICU diaries are easy to implement and scalable and show promise for reducing distress after CA but are primarily targeted towards survivors. The primary aim of the Family-Authored ICU Diaries to reduce Fear in Patients Experiencing a CA (FAID Fear) pilot randomized controlled trial was to test feasibility of an ICU diary intervention targeted towards family member distress alone. Family members of patients hospitalized after CA (N = 16) were randomized 2:1 to receive the FAID Fear intervention or usual care. Intervention participants were provided brief instructions and were asked to write in the diary twice per week until the end of hospital care. Assessments occurred at baseline enrollment, end of hospital care, and 30 days later. Participants' mean age was 50.73 years (SD = 13.41; 80% cis-gender female; 60% White). Recruitment (16/25 referred; 64.0%), retention (14/16 enrolled; 87.5%), and intervention adherence (7/10 completed; 70%) were promising. Most agreed that the ICU diary intervention was appropriate (7/10 completed; 70.0%), feasible (9/10 completed; 90.0%]), and acceptable (8/10 completed; 80.0%). Fear was nonsignificantly lower in intervention participants (v. control) at end of hospital care and 30 days later. FAID Fear represents a first step in building theory-based dyadic interventions that can be implemented to support family members of CA survivors in the ICU, with potential to improve outcomes in CA survivors.

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).