Atrial Fibrillation, Cardiac Symptoms, and Anxiety



Status:Suspended
Conditions:Anxiety, Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:1/17/2019
Start Date:September 2014
End Date:January 2020

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This is an investigation of a mindfulness and interoceptive exposure intervention in patients
with atrial fibrillation, to decrease anxiety sensitivity, symptom burden, and atrial
fibrillation recurrence.

Patients with atrial fibrillation (AF) have a poorer quality of life and have elevated rates
of anxiety. Higher anxiety and somatization has been associated with more severe AF symptoms.
Increased anxiety symptoms have also been associated with increased medical visits for AF
management. Some studies show that anxiety may increase the risk of AF recurrence following
medical intervention, including increasing AF recurrence after circumferential pulmonary vein
ablation. Growing evidence suggests a pressing need to treat anxiety and improve quality of
life among AF patients, yet few data exist about how to accomplish this. Mindfulness-based
behavioral treatments offer promise in this regard.

Interoceptive Exposure (IE) is an evidence-based cognitive behavioral intervention to address
intolerance of anxiety-related physical sensations, commonly seen in panic disorder and other
anxiety disorders. It involves systematically and repeatedly inducing feared physical
sensations to promote increased tolerance and reduced distress associated with these
symptoms.

Mindfulness is defined as paying attention to the present moment in an open and nonjudgmental
way. Mindfulness-based behavioral interventions have been successfully applied in various
psychiatric and medical patient populations, including cardiac patients. Two meta-analyses
suggest that mindfulness-based interventions are moderately effective for reducing distress
related to physical or psychosomatic illnesses.

The investigators of this study hypothesize that a mindfulness and IE intervention will
decrease anxiety, AF symptoms and AF recurrence, and will improve quality of life among
patients with AF.

This is a pilot, prospective trial of a mindfulness and IE intervention in patients with AF.
The mindfulness and IE intervention will be delivered in four to five, manualized, individual
sessions.

Inclusion Criteria:

- Male or female outpatients

- At least 18 years of age

- Clinical diagnosis of Atrial Fibrillation

- Literacy and fluency in English

- Ability to return to the hospital for study visits

- Score ≥ 24 on the Anxiety Sensitivity Index-3.

Exclusion Criteria:

- Medical co-morbidity sufficient to confound the outcome variables

- Medical co-morbidity for which the experimental treatment is contraindicated

- Clinically significant cognitive impairment

- Known unavailability for follow-up in the ensuing 3 months
We found this trial at
1
site
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Meghan S Kolodziej, MD
Phone: 617-278-0825
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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