Interventional Study of Anxiety Symptoms in the Implantable Cardioverter Defibrillator (ICD) Patient

This study is an interventional study of patients with ICDs followed in the Cleveland Clinic
Device Clinic. Patients with ICDs experience some level of anxiety which can impact the
number of shocks that they receive from their Device. 100 of these patients will be
randomized into one of 2 groups; those receiving three sessions of Cognitive Behavioral
Therapy (CBT) and those receiving usual care. We hypothesize that if these ICD patients
receive short term (CBT) they will experience less anxiety and have a lower rate of device
firings than the patients that did not receive CBT. Furthermore, we will study mechanistic
pathways involved in the reduction of anxiety in ICD patients. We will extract initial heart
rate variability (HRV) data from device interrogation. We hypothesize that the CBT
intervention arm will have a higher normalization of HRV. Patients will repeat questionnaires
at 3, 6 and 12 months.

Inclusion Criteria:

- Currently has an Implantable Cardioverter Defibrillator (ICD)

- Experiences moderate to high anxiety as demonstrated by the the scores on the
questionnaires that will be administered

Exclusion Criteria:

- Unwilling to comply with follow-up requirements at 3, 6 and 12 months.