WEB-based distress management program for implantable CARdioverter dEfibrillator patients (WEBCARE)

The implantable cardioverter defibrillator (ICD) constitutes the treatment of choice in patients who have experienced life-threatening cardiac arrhythmias and in patients at risk for these cardiac arrhythmias. Several clinical trials have shown that the ICD is superior to antiarrhythmic drugs in the prevention of sudden cardiac death. The ICD can terminate life-threatening arrhythmias by antitachycardia pacing or shocks. Despite the medical benefits of ICD treatment, 25-35% of ICD patients experience clinical levels of anxiety and poor quality of life. Adaptation problems have several causes, including the experience of resuscitation and the unpredictable reoccurrence of life-threatening arrhythmias and ICD therapies. For these patients, behavioral intervention may be warranted in order to reduce distress and secondary outcomes, such as avoidance behavior, physical inactivity, and poor quality of life. In addition, preliminary evidence indicates that emotional distress may precipitate life-threatening arrhythmic events, with a successful reduction in distress potentially leading to a decrease in these arrhythmias. Given the exponential rise in ICD implantations and the projected increase in the future, knowledge of the efficacy of behavioral interventions is important in order to optimize clinical management of these patients. The proposed behavioral intervention will be web-based, comprising 8 modules with a duration of 3 months starting just after ICD implantation. The main components include education about the ICD, cognitive restructuring and problem-solving skills, and relaxation training. The general objective of the intervention trial will be to evaluate the effect of this web-based behavioral intervention on psychological outcomes (i.e., anxiety and quality of life), physiological parameters (i.e., ventricular arrhythmias and salivary cortisol levels), and self-care and health-care utilization. In addition, the potential moderating influence of psychological (i.e., personality and positive affect) and clinical (i.e., cardiac synchronization therapy) factors on the effectiveness of the intervention will be determined. Finally, the cost-effectiveness of the intervention will be evaluated. The intervention is hypothesized to lead to decreased levels of anxiety and ICD concerns and to better acceptance of the ICD and improved quality of life. Psychological factors (i.e., personality and positive affect) and clinical factors (i.e., cardiac resynchronization therapy) are expected to moderate the effect of the intervention on these outcomes. Type D personality (i.e., increased negative affectivity paired with emotional non-expression) and low positive affect are hypothesized to lead to poor adjustment and more emotional distress, whereas cardiac resynchronization therapy is expected to lead to improved outcome. Furthermore, we expect that the intervention leads to a reduction in health-care utilization, and will therefore be cost-effective. Finally, we hypothesize that a reduction in distress levels may lead to a decrease in ventricular arrhythmias and the cortisol awakening response. Consecutive ICD patients (N = 438) will be recruited from four centers in the Netherlands (Amphia Hospital Breda, Catharina Hospital Eindhoven, Erasmus Medical Center Rotterdam, and University Medical Center Utrecht). The study design is a prospective, multi-center, multi-disciplinary, randomized controlled web-based behavioral intervention trial, with usual care comprising the comparison group. Standardized and validated questionnaires will be administered at four time points. At baseline (i.e., 1 day prior to implantation and randomization), 3 months (i.e., at the end of the intervention), and 6 and 12 months. Salivary cortisol will be assessed at the majority of these time points. Information on the occurrence of life-threatening arrhythmias will be obtained from the patients' medical records. OBJECTIVES Primary 1. To investigate whether the web-based intervention is superior to usual care in terms of reducing anxiety and ICD concerns as well as improving ICD acceptance and quality of life. 2. To investigate whether the web-based intervention is cost-effective and leads to a reduction in health-care utilization in the intervention group as compared to the usual care group. Secondary 1. To examine whether psychological (i.e., Type D personality and positive affect) and clinical factors (i.e., cardiac resynchronization therapy) moderate the effect of the intervention, with a view to developing risk profiles of patients who are less likely to benefit from the intervention. Exploratory 1. To explore whether the web-based intervention influences physiological parameters (i.e., ventricular arrhythmias and the cortisol awakening response).