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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by The Cleveland Clinic.
Recruitment status was:  Recruiting
Information provided by:
The Cleveland Clinic Identifier:
First received: February 23, 2009
Last updated: February 1, 2010
Last verified: February 2010
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 Intervention
Behavioral: Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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."

Resource links provided by NLM:

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2009
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cognitive Behavioral Therapy 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.

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.

Ages Eligible for Study:   Child, Adult, Senior
Genders 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00851071

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Mina Chung, The Cleveland Clinic Identifier: NCT00851071     History of Changes
Other Study ID Numbers: IRB# 08-913 
Study First Received: February 23, 2009
Last Updated: February 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Implantable Cardioverter Defibrillator (ICD)
Defibrillators, Implantable

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders processed this record on January 17, 2017