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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00851071
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : December 22, 2017
Information provided by (Responsible Party):
Mina Chung, 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.

Condition or disease Intervention/treatment Phase
Anxiety Behavioral: Cognitive Behavioral Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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."
Actual Study Start Date : February 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 20, 2017

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00851071

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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
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Principal Investigator: Mina K Chung, MD The Cleveland Clinic
Principal Investigator: Leopoldo J Pozuelo, MD The Cleveland Clinic

Study Data/Documents: Publication  This link exits the site
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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mina Chung, MD, The Cleveland Clinic Identifier: NCT00851071     History of Changes
Other Study ID Numbers: IRB# 08-913
First Posted: February 25, 2009    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mina Chung, The Cleveland Clinic:
Implantable Cardioverter Defibrillator (ICD)
Defibrillators, Implantable
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders