Clinical trial NCT00851071: Interventional Study of Anxiety Symptoms in the Implantable Cardioverter Defibrillator (ICD) Patient
Official title: Bakken Heart Brain Institute's "An Observational and Interventional Study of Anxiety Symptoms in the Implantable Cardioverter Defibrillator (ICD) Patient."
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Anxiety
Implantable Cardioverter Defibrillator (ICD)
Defibrillators, Implantable
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2009-02-25
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Patients in the CBT arm will have (3) 45min. sessions scheduled over a 3 month period.
Secondary outcomes:
measure: Patients in the CBT intervention arm will have a lower rate of firings (shocks).
timeFrame: Patients in both arms will have their ICD's interrogated at 3, 6 and 9 months.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Mina K Chung, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Leopoldo J Pozuelo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.