Breathing Intervention for Cardiac Anxiety

Not Applicable

Terminated

• Conditions: Atrial Fibrillation; Implantable Cardioverter Defibrillator
• Interventions: Behavioral: Breathing exercise

• Registration Number: NCT02916550
• Lead Sponsor: Laureate Institute for Brain Research, Inc.

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-27
• Primary Completion: 2021-09
• Study Completion: 2023-05
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Cardiac anxiety	1 month	Assessed via the Cardiac Anxiety Questionnaire

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Laureate Institute for Brain Research; 🇺🇸 Tulsa, Oklahoma, United States