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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy | Active Comparator | Three individual 45 minute cognitive behavioral therapy sessions over a 3 month period |
|
| Usual Care Arm | No Intervention | The Usual Care Arm will be the control arm. These patients will not be scheduled with any CBT sessions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | Three 45 minute CBT sessions scheduled over a 3 month period. |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mina K Chung, MD | The Cleveland Clinic | Principal Investigator |
| Leopoldo J Pozuelo, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25779222 | Derived | Qintar M, George JJ, Panko M, Bea S, Broer KA, St John J, Blissett KA, Ching E, Sears SF, Pedersen SS, Pozuelo L, Chung MK. A prospective study of anxiety in ICD patients with a pilot randomized controlled trial of cognitive behavioral therapy for patients with moderate to severe anxiety. J Interv Card Electrophysiol. 2015 Jun;43(1):65-75. doi: 10.1007/s10840-015-9990-7. Epub 2015 Mar 17. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Publication | View IPD |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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A prospective study of anxiety in ICD patients with a pilot randomized controlled trial of cognitive behavioral therapy for patients with moderate to severe anxiety Mohammed Qintar & Jason J. George & Melanie Panko & Scott Bea & Karen A. Broer & Julie St. John & Kecia-Ann Blissett & Elizabeth Ching & Samuel F. Sears & Susanne S. Pedersen & Leopoldo Pozuelo & Mina K. Chung |