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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851071
• Other study ID #: IRB# 08-913
• Status: Completed
• Phase: N/A
• First received: February 23, 2009
• Last updated: December 20, 2017
• Start date: February 2009
• Est. completion date: December 20, 2017

Study information

• Verified date: December 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 20, 2017
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• Cognitive Behavioral Therapy
Three 45 minute CBT sessions scheduled over a 3 month period.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.