Breathing Intervention for Cardiac Anxiety

Anatomical and Psychophysiological Substrates of Interoception

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

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation; Implantable Cardioverter Defibrillator
• Intervention / Treatment: Behavioral: Breathing exercise

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Laureate Institute for Brain Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Laureate Institute for Brain Research, Inc.
• Collaborators: University of Arizona
• Investigators: Principal Investigator: Sahib Khalsa, MD, PhD, Laureate Institute for Brain Research

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: September 26, 2016
• First Submitted That Met QC Criteria: September 26, 2016
• First Posted (Estimated): September 27, 2016

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: Laureateinstitute

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Not IPD, just de-identified data.