Breathing Intervention for Cardiac Anxiety

Atrial Fibrillation Clinical Trial

Official title:

Anatomical and Psychophysiological Substrates of Interoception

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02916550
• Other study ID #: Laureateinstitute
• Status: Terminated
• Phase: N/A
• Start date: September 2016
• Est. completion date: May 2023

Study information

• Verified date: October 2023
• Source: Laureate Institute for Brain Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: May 2023
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Implantable Cardioverter Defibrillator

Intervention

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.

Locations

Country	Name	City	State
United States	Laureate Institute for Brain Research	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Laureate Institute for Brain Research, Inc.	University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac anxiety	Assessed via the Cardiac Anxiety Questionnaire	1 month
Secondary	Disability	Measured by the WHO Disability Assessment Scale (WHODAS)	1 month
Secondary	Wellbeing	NIH Patient Reported Outcome Measurement Information System (PROMIS)	1 month
Secondary	ICD anxiety	Florida Shock Anxiety Scale	1 month
Secondary	Arrhythmia burden	Presence of atrial fibrillation or ICD shocks	1 month