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

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

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 Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cognitive Behavioral Therapy; Three individual 45 minute cognitive behavioral therapy sessions over a 3 month period	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Mina K Chung, MD, The Cleveland Clinic; Principal Investigator: Leopoldo J Pozuelo, MD, The Cleveland Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 20, 2017

Study Registration Dates

• First Submitted: February 23, 2009
• First Submitted That Met QC Criteria: February 24, 2009
• First Posted (Estimate): February 25, 2009

Study Record Updates

• Last Update Posted (Actual): December 22, 2017
• Last Update Submitted That Met QC Criteria: December 20, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Anxiety; Implantable Cardioverter Defibrillator (ICD); Defibrillators, Implantable
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: IRB# 08-913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Study Data/Documents

1. Publication
   Information comments: 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 Mohammed Qintar & Jason J. George & Melanie Panko & Scott Bea & Karen A. Broer & Julie St. John & Kecia-Ann Blissett & Elizabeth Ching & Samuel F. Sears & Susanne S. Pedersen & Leopoldo Pozuelo & Mina K. Chung

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No