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Interventional Study of Anxiety Symptoms in the Implantable Cardioverter Defibrillator (ICD) Patient - NCT00851071-44195(Clinical Trial 274598)



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City:  Cleveland
State:  
OH
Zip Code: 44195
Conditions: Anxiety
Purpose: 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.
Study summary: 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.
Criteria: 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.
Study is available at: Cleveland Clinic
Cleveland, OH 44195
United States

Primary Contact:
Melanie A Panko, RN, BSN
Email: pankom@ccf.org
Phone: 216-444-6478

Secondary Contact:
Melanie A Panko, RN, BSN
Phone: (216)444-6478
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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