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

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Behavioral: Cognitive Behavioral Therapy

• Registration Number: NCT00851071
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-23
• Study First Submitted QC: 2009-02-24
• Study First Posted: 2009-02-25
• Primary Completion: 2011-12
• Status Verified: 2017-12
• Study Completion: 2017-12-20
• Last Update Submitted: 2017-12-20
• Last Update Posted: 2017-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy	Cognitive Behavioral Therapy	Three individual 45 minute cognitive behavioral therapy sessions over a 3 month period

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States