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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00851071

Enrollment

Registered

2009-02-25

Start date

2009-02-28

Completion date

2017-12-20

Last updated

2017-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

Anxiety, Implantable Cardioverter Defibrillator (ICD), Defibrillators, Implantable

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.

Interventions

BEHAVIORALCognitive Behavioral Therapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026