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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Bakken Heart Brain Institute's An Observational and Interventional Study of Anxiety Symptoms in the Implantable Cardioverter Defibrillator (ICD) Patient.

Conditions
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Anxiety

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive Behavioral Therapy<br>Three individual 45 minute cognitive behavioral therapy sessions over a 3 month period | Behavioral: Cognitive Behavioral Therapy<br>* Three 45 minute CBT sessions scheduled over a 3 month period.<br>|
| No Intervention: Usual Care Arm<br>The Usual Care Arm will be the control arm. These patients will not be scheduled with any CBT sessions. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients in the CBT intervention arm will have a higher reduction in anxiety and experience better quality of life compared to usual care at 3 months. |  | Patients in the CBT arm will have (3) 45min. sessions scheduled over a 3 month period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients in the CBT intervention arm will have a lower rate of firings (shocks). |  | Patients in both arms will have their ICD's interrogated at 3, 6 and 9 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Implantable Cardioverter Defibrillator (ICD), Defibrillators, Implantable