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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mina Chung, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00851071
First received: February 23, 2009
Last updated: January 24, 2017
Last verified: January 2017
  Purpose
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
Anxiety
Behavioral: Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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. ]

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. ]

Enrollment: 28
Actual Study Start Date: February 2009
Estimated Study Completion Date: December 2017
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00851071

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

Study Data/Documents: Publication  This link exits the ClinicalTrials.gov 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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mina Chung, MD, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00851071     History of Changes
Other Study ID Numbers: IRB# 08-913
Study First Received: February 23, 2009
Last Updated: January 24, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 24, 2017