Back to resultsBreathing Intervention for Cardiac Anxiety
Primary Purpose
Atrial Fibrillation, Implantable Cardioverter Defibrillator
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breathing exercise
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
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.
Sites / Locations
- Laureate Institute for Brain Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Breathing exercise
Arm Description
Participants will perform a paced breathing intervention (slow breathing) prompted by pseudorandomized remote reminders (scheduled reminders plus non scheduled reminders), through cellular phone application.
Outcomes
Primary Outcome Measures
Cardiac anxiety
Assessed via the Cardiac Anxiety Questionnaire
Secondary Outcome Measures
Disability
Measured by the WHO Disability Assessment Scale (WHODAS)
Wellbeing
NIH Patient Reported Outcome Measurement Information System (PROMIS)
ICD anxiety
Florida Shock Anxiety Scale
Arrhythmia burden
Presence of atrial fibrillation or ICD shocks
Full Information
NCT ID
NCT02916550
First Posted
September 26, 2016
Last Updated
October 4, 2023
Sponsor
Laureate Institute for Brain Research, Inc.
Collaborators
University of Arizona
1. Study Identification
Unique Protocol Identification Number
NCT02916550
Brief Title
Breathing Intervention for Cardiac Anxiety
Official Title
Anatomical and Psychophysiological Substrates of Interoception
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Recruitment rate was lower than anticipated, preventing the study from achieving target sample size.
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2021 (Actual)
Study Completion Date
May 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laureate Institute for Brain Research, Inc.
Collaborators
University of Arizona
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Implantable Cardioverter Defibrillator
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breathing exercise
Arm Type
Experimental
Arm Description
Participants will perform a paced breathing intervention (slow breathing) prompted by pseudorandomized remote reminders (scheduled reminders plus non scheduled reminders), through cellular phone application.
Intervention Type
Behavioral
Intervention Name(s)
Breathing exercise
Intervention Description
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 Measure Information:
Title
Cardiac anxiety
Description
Assessed via the Cardiac Anxiety Questionnaire
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Disability
Description
Measured by the WHO Disability Assessment Scale (WHODAS)
Time Frame
1 month
Title
Wellbeing
Description
NIH Patient Reported Outcome Measurement Information System (PROMIS)
Time Frame
1 month
Title
ICD anxiety
Description
Florida Shock Anxiety Scale
Time Frame
1 month
Title
Arrhythmia burden
Description
Presence of atrial fibrillation or ICD shocks
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahib Khalsa, MD, PhD
Organizational Affiliation
Laureate Institute for Brain Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laureate Institute for Brain Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Not IPD, just de-identified data.
Learn more about this trial
Breathing Intervention for Cardiac Anxiety
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