Breathing Intervention for Cardiac Anxiety

Laureate Institute for Brain Research, Inc.12 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation Implantable Cardioverter Defibrillator

Interventions

Breathing exerciseBEHAVIORAL

Participants will perform a paced breathing intervention (slow breathing) prompted by pseudorandomized remote reminders (scheduled reminders plus non scheduled reminders), through cellular phone application.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: 1. 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) 2. American College of Cardiology/American Heart Association congestive heart failure stage D (i.e., heart failure symptoms at rest, receiving end of life care). 3. Unstable angina or exercise induced angina 4. 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.

Locations (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, United States

Outcomes

Primary Outcomes

Cardiac anxiety

Assessed via the Cardiac Anxiety Questionnaire

Time frame: 1 month

Secondary Outcomes

Disability

Measured by the WHO Disability Assessment Scale (WHODAS)

Time frame: 1 month

Wellbeing

NIH Patient Reported Outcome Measurement Information System (PROMIS)

Time frame: 1 month

ICD anxiety

Florida Shock Anxiety Scale

Time frame: 1 month

Arrhythmia burden

Presence of atrial fibrillation or ICD shocks

Time frame: 1 month

Data from ClinicalTrials.gov

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