Interventional Study of Anxiety Symptoms in the Implantable Cardioverter Defibrillator (ICD) Patient
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About
This study will compare the effectiveness that Cognitive Behavioral Therapy has on decreasing the amount of anxiety, as well as the number of inappropriate firings that a patient with an ICD may experience.
Full description
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.
Enrollment
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Volunteers
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.
Trial design
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Interventional model
Masking
28 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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