Background. Primary and secondary prevention trials have shown that implantable cardioverter-defibrillators (ICD) reduce the risk of cardiac death, but concerns have been raised regarding the psychological well-being of ICD patients. Anxiety can affect a significant proportion of these patients, but there is limited information about prevalence and determinants of anxiety after the implementation of the more recent guidelines for ICD implantation. Several behavioral interventions have been effective in improving anxiety in these patients, however the efficacy of mindfulness-based interventions (MBI) has not been investigated in ICD patients, and there is limited information regarding the characteristics of pre-intervention, “dispositional” mindfulness in patients with cardiovascular disease never exposed to mindfulness training. The aims of this dissertation project were: 1) To determine the feasibility of a randomized clinical trial of a phone-administered, mindfulness-based training program, as measured by recruitment and retention rates, treatment adherence and fidelity; 2) To evaluate the current baseline prevalence and determinants of anxiety in the study population and 3) To describe the correlates of dispositional mindfulness in the study population. Methods. The study was conducted at the Electrophysiology Service at the UMass Memorial Medical Center. All consecutive patients who recently underwent an ICD procedure or received ICD shocks were screened for eligibility to participate in a pilot randomized controlled trial in which an eight session, phone-delivered, weekly MBI was compared to a usual care condition. Assessments were performed at baseline and post-intervention. A cross-sectional design was used for aims 2 and 3. Anxiety was assessed using the Hospital Anxiety and Depression Scale; a shortened version of the Five Facets of Mindfulness questionnaire was used to evaluate mindfulness. Results. Thirty patients (21 M, 9 F; mean age 63.1 ±10.3 years) were enrolled in the study. The methods ultimately adopted to screen, recruit, and retain study participants were feasible to conduct and satisfactory to ICD outpatients, and the study intervention was safe. Phone delivery resulted in excellent retention rates and limited costs. Assessments of treatment fidelity showed that the content of the intervention was delivered as intended in almost 100% of cases. The study findings do not show a decrease in the overall prevalence of anxiety in ICD patients compared with earlier cohorts; anxiety was associated with young age, low socio-economic status and previous psychological morbidity, but not with ICD-related factors including prior shock delivery. Finally, baseline mindfulness was most strongly associated with previous psychological morbidity (in particular, depression), and current anxiety symptoms. Conclusion. Psychological morbidity appears to be the major determinant of anxiety in the patients currently enrolled in the study. Dispositional mindfulness is inversely associated with current anxiety and depression and with prior psychological morbidity, supporting the hypothesis of a modulating role of mindfulness on the processing of negative emotions. A phone-delivered, individual MBI is feasible, acceptable to patients and can be adequately delivered by trained instructors. The findings from this dissertation work support the need for larger clinical trials of MBI in ICD patients.

Background. Meditation practices are associated with a reduction in adrenergic activity that may benefit patients with severe cardiac arrhythmias. This paper describes the design and methods of a pilot study testing the feasibility of a phone-delivered mindfulness-based intervention (MBI) for treatment of anxiety in patients with implantable cardioverter defibrillators (ICDs). Design and Methods. Consecutive, clinically stable outpatients (n = 52) will be screened for study eligibility within a month of an ICD-related procedure or ICD shock and will be randomly assigned to MBI or to usual care. MBI patients will receive eight weekly individual phone sessions based on two mindfulness practices (awareness of breath and body scan) plus home practice with a CD for 20 minutes daily. Patients assigned to usual care will be offered the standard care planned by the hospital. Assessments will occur at baseline and at the completion of the intervention (between 9 and 12 weeks after randomization). The primary study outcome is feasibility; secondary outcomes include anxiety, mindfulness, and number of administered shocks during the intervention period. Conclusions. If proven feasible and effective, phone-delivered mindfulness-based interventions could improve psychological distress in ICD outpatients with serious cardiovascular conditions.

Background The reduction in adrenergic activity and anxiety associated with meditation may be beneficial for patients with implantable cardioverter defibrillators. Purpose This study aims to determine the feasibility of a phone-delivered mindfulness intervention in patients with defibrillators and to obtain preliminary indications of efficacy on mindfulness and anxiety. Methods Clinically stable outpatients were randomized to a mindfulness intervention (eight weekly individual phone sessions) or to a scripted follow-up phone call. We used the Hospital Anxiety and Depression Scale and the Five Facets of Mindfulness to measure anxiety and mindfulness, and multivariate linear regression to estimate the intervention effect on pre-post-intervention changes in these variables. Results We enrolled 45 patients (23 mindfulness and 22 control; age, 43–83; 30 % women). Retention was 93 %; attendance was 94 %. Mindfulness (beta = 3.31; p = 0.04) and anxiety (beta = −1.15; p = 0.059) improved in the mindfulness group. Conclusions Mindfulness training can be effectively phone-delivered and may improve mindfulness and anxiety in cardiac defibrillator outpatients.