Interventional Study of Anxiety Symptoms in the Implantable Cardioverter Defibrillator (ICD) Patient
Recruitment status was Recruiting
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Bakken Heart Brain Institute's "An Observational and Interventional Study of Anxiety Symptoms in the Implantable Cardioverter Defibrillator (ICD) Patient."|
- 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. [ Time Frame: Patients in the CBT arm will have (3) 45min. sessions scheduled over a 3 month period. ] [ Designated as safety issue: No ]
- Patients in the CBT intervention arm will have a lower rate of firings (shocks). [ Time Frame: Patients in both arms will have their ICD's interrogated at 3, 6 and 9 months. ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Estimated Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
|Active Comparator: Cognitive Behavioral Therapy||
Behavioral: Cognitive Behavioral Therapy
Three 45 minute CBT sessions scheduled over a 3 month period.
No Intervention: Usual Care Arm
The Usual Care Arm will be the control arm. These patients will not be scheduled with any CBT sessions.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00851071
|Contact: Melanie A Panko, RN, BSN||(216)444-6478|
|Contact: Stephanie Spencer||(216)444-2520|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Melanie A Panko, RN, BSN 216-444-6478 email@example.com|
|Principal Investigator:||Mina K Chung, MD||The Cleveland Clinic|
|Principal Investigator:||Leopoldo J Pozuelo, MD||The Cleveland Clinic|