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Completed

NCT Number: NCT00851071

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive behavioral therapy

Behavioral

Three 45 minute CBT sessions scheduled over a 3 month period.

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.

    Time frame: 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).

    Time frame: Patients in both arms will have their ICD's interrogated at 3, 6 and 9 months.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Bakken Heart Brain Institute's "An Observational and Interventional Study of Anxiety Symptoms in the Implantable Cardioverter Defibrillator (ICD) Patient."

Important dates

Study start
2009
Primary completion
2011
Study completion
2017
First posted
Feb 25, 2009
Registry last updated
Dec 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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