Breathing Intervention for Cardiac Anxiety

Study Overview
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Brief Summary
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This study examines the impact of a breathing training intervention on cardiorespiratory sensations and anxiety in adults with cardiac arrhythmias.

Detailed Description
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Patients with cardiac arrhythmias develop increased rates of anxiety and depression. Atrial arrhythmias, such as paroxysmal atrial fibrillation (AF), and ventricular arrhythmias, such as those with implantable cardioverter defibrillators (ICD) are particularly at risk. While ICDs can be life saving, many patients (including those without prior psychiatric illness) develop elevated rates of anxiety and depression, particularly after receiving discharges (shocks) from the device. Treatments involving modulation of the breath have been shown to improve both psychological and cardiac outcomes in patients with AF. Since breathing modulation alters sympathetic balance, this may be a mechanism of the therapeutic effect. This study examines the impact of a breathing training intervention on cardiorespiratory sensations and anxiety in adults with atrial and ventricular cardiac arrhythmias.

Official Title
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Anatomical and Psychophysiological Substrates of Interoception

Conditions
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Atrial Fibrillation, Implantable Cardioverter Defibrillator

Intervention / Treatment
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* Behavioral: Breathing exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 80 BMI 17 to 35 Proficient in English language Paroxysmal atrial fibrillation or ventricular fibrillation or frequent premature atrial/ventricular contractions Exclusion Criteria: No telephone access Active suicidal ideation with intent or plan Active drug or alcohol dependence, or active binge drinking within the last month Cardiovascular instability, as evidenced any of the following: New York Heart Association (NHYA) heart failure class IV (i.e., unable to carry on any physical activity without discomfort, symptoms of heart failure at rest, increased discomfort with any physical activity is undertaken) American College of Cardiology/American Heart Association congestive heart failure stage D (i.e., heart failure symptoms at rest, receiving end of life care). Unstable angina or exercise induced angina Persistent atrial fibrillation Pacemakers or combined pacemaker/ICDs will be excluded Presence of unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disease; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breathing exercise<br>Participants will perform a paced breathing intervention (slow breathing) prompted by pseudorandomized remote reminders (scheduled reminders plus non scheduled reminders), through cellular phone application. | Behavioral: Breathing exercise<br>* Participants will perform a paced breathing intervention (slow breathing) prompted by pseudorandomized remote reminders (scheduled reminders plus non scheduled reminders), through cellular phone application.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac anxiety | Assessed via the Cardiac Anxiety Questionnaire | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability | Measured by the WHO Disability Assessment Scale (WHODAS) | 1 month | 
| Wellbeing | NIH Patient Reported Outcome Measurement Information System (PROMIS) | 1 month | 
| ICD anxiety | Florida Shock Anxiety Scale | 1 month | 
| Arrhythmia burden | Presence of atrial fibrillation or ICD shocks | 1 month |