Interventional Study of Anxiety Symptoms in the Implantable Cardioverter Defibrillator (ICD) Patient
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Implantable Cardioverter Defibrillator (ICD), Defibrillators, Implantable
Eligibility Criteria
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.
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Cognitive Behavioral Therapy
Usual Care Arm
Arm Description
Three individual 45 minute cognitive behavioral therapy sessions over a 3 month period
The Usual Care Arm will be the control arm. These patients will not be scheduled with any CBT sessions.
Outcomes
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.
Secondary Outcome Measures
Patients in the CBT intervention arm will have a lower rate of firings (shocks).
Full Information
NCT ID
NCT00851071
First Posted
February 23, 2009
Last Updated
December 20, 2017
Sponsor
The Cleveland Clinic
1. Study Identification
Unique Protocol Identification Number
NCT00851071
Brief Title
Interventional Study of Anxiety Symptoms in the Implantable Cardioverter Defibrillator (ICD) Patient
Official Title
Bakken Heart Brain Institute's "An Observational and Interventional Study of Anxiety Symptoms in the Implantable Cardioverter Defibrillator (ICD) Patient."
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 2009 (Actual)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Anxiety, Implantable Cardioverter Defibrillator (ICD), Defibrillators, Implantable
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavioral Therapy
Arm Type
Active Comparator
Arm Description
Three individual 45 minute cognitive behavioral therapy sessions over a 3 month period
Arm Title
Usual Care Arm
Arm Type
No Intervention
Arm Description
The Usual Care Arm will be the control arm. These patients will not be scheduled with any CBT sessions.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
Three 45 minute CBT sessions scheduled over a 3 month period.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mina K Chung, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leopoldo J Pozuelo, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25779222
Citation
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.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
Publication
Available IPD/Information URL
http://link.springer.com/article/10.1007%2Fs10840-015-9990-7
Available IPD/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
Learn more about this trial
Interventional Study of Anxiety Symptoms in the Implantable Cardioverter Defibrillator (ICD) Patient
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