Mindfulness-based emotional regulation for patients with implantable cardioverter-defibrillators: A randomized pilot study of efficacy, applicability, and safety.

BACKGROUND: The efficacy of mindfulness-based interventions to reduce anxiety or improve quality of life (QoL) in patients with cardiac pathologies is well established. However, there is scarce information on the efficacy, applicability, and safety of these interventions in adult patients with an implantable cardioverter-defibrillator (ICD). In this study, we examined their efficacy on QoL, psychological and biomedical variables, as well as the applicability and safety of a mindfulness-based intervention in patients with an ICD. METHODS: Ninety-six patients with an ICD were randomized into two intervention groups and a control group. The interventions involved training in mindfulness-based emotional regulation, either face-to- -face or using the "REM Volver a casa" mobile phone application (app). RESULTS: The sample presented medium-high QoL baseline scores (mean: 68), low anxiety (6.84) and depression (3.89), average mindfulness disposition (128), and cardiological parameters similar to other ICD populations. After the intervention, no significant differences were found in the variables studied between the intervention and control groups. Retention was average (59%), and there were no adverse effects due to the intervention. CONCLUSIONS: After training in mindfulness-based emotional regulation (face-to-face or via app), no significant differences were found in the QoL or psychological or biomedical variables in patients with an ICD. The intervention proved to be safe, with 59% retention.