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."
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable anxiety
Started Feb 2009
Longer than P75 for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 23, 2009
CompletedFirst Posted
Study publicly available on registry
February 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2017
CompletedDecember 22, 2017
December 1, 2017
2.8 years
February 23, 2009
December 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Patients in the CBT arm will have (3) 45min. sessions scheduled over a 3 month period.
Secondary Outcomes (1)
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.
Study Arms (2)
Cognitive Behavioral Therapy
ACTIVE COMPARATORThree individual 45 minute cognitive behavioral therapy sessions over a 3 month period
Usual Care Arm
NO INTERVENTIONThe Usual Care Arm will be the control arm. These patients will not be scheduled with any CBT sessions.
Interventions
Three 45 minute CBT sessions scheduled over a 3 month period.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Unwilling to comply with follow-up requirements at 3, 6 and 12 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Related Publications (1)
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.
PMID: 25779222DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mina K Chung, MD
The Cleveland Clinic
- PRINCIPAL INVESTIGATOR
Leopoldo J Pozuelo, MD
The Cleveland Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 23, 2009
First Posted
February 25, 2009
Study Start
February 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 20, 2017
Last Updated
December 22, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share