Atrial Fibrillation, Cardiac Symptoms, and Anxiety

Study Overview
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Brief Summary
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This is an investigation of a mindfulness and interoceptive exposure intervention in patients with atrial fibrillation, to decrease anxiety sensitivity, symptom burden, and atrial fibrillation recurrence.

Detailed Description
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Patients with atrial fibrillation (AF) have a poorer quality of life and have elevated rates of anxiety. Higher anxiety and somatization has been associated with more severe AF symptoms. Increased anxiety symptoms have also been associated with increased medical visits for AF management. Some studies show that anxiety may increase the risk of AF recurrence following medical intervention, including increasing AF recurrence after circumferential pulmonary vein ablation. Growing evidence suggests a pressing need to treat anxiety and improve quality of life among AF patients, yet few data exist about how to accomplish this. Mindfulness-based behavioral treatments offer promise in this regard. Interoceptive Exposure (IE) is an evidence-based cognitive behavioral intervention to address intolerance of anxiety-related physical sensations, commonly seen in panic disorder and other anxiety disorders. It involves systematically and repeatedly inducing feared physical sensations to promote increased tolerance and reduced distress associated with these symptoms. Mindfulness is defined as paying attention to the present moment in an open and nonjudgmental way. Mindfulness-based behavioral interventions have been successfully applied in various psychiatric and medical patient populations, including cardiac patients. Two meta-analyses suggest that mindfulness-based interventions are moderately effective for reducing distress related to physical or psychosomatic illnesses. The investigators of this study hypothesize that a mindfulness and IE intervention will decrease anxiety, AF symptoms and AF recurrence, and will improve quality of life among patients with AF. This is a pilot, prospective trial of a mindfulness and IE intervention in patients with AF. The mindfulness and IE intervention will be delivered in four to five, manualized, individual sessions.

Official Title
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Atrial Fibrillation, Cardiac Symptoms, and Anxiety

Conditions
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Atrial Fibrillation, Anxiety

Intervention / Treatment
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* Behavioral: Mindfulness and Interoceptive Exposure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female outpatients At least 18 years of age Clinical diagnosis of Atrial Fibrillation Literacy and fluency in English Ability to return to the hospital for study visits Score ≥ 24 on the Anxiety Sensitivity Index-3. Exclusion Criteria: Medical co-morbidity sufficient to confound the outcome variables Medical co-morbidity for which the experimental treatment is contraindicated Clinically significant cognitive impairment Known unavailability for follow-up in the ensuing 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mindfulness and Interoceptive Exposure<br>Atrial fibrillation patients will receive 4-5 manualized, individualized sessions of Mindfulness and Interoceptive Exposure. | Behavioral: Mindfulness and Interoceptive Exposure<br>* The Mindfulness and Interoceptive Exposure intervention will be delivered in 4-5 manualized, individualized therapy sessions, of 1.5 hours - 2 hours each. The intervention is comprised of four established cognitive-behavioral strategies: psychoeducation, mindfulness, interoceptive exposure and skills generalization.<br>|
| No Intervention: Medical care as usual<br>Atrial fibrillation patients will receive medical and cardiac care as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac symptoms as measured by the Cardiac Symptom Questionnaire (CSQ). | The CSQ is a 15 item, self-report, symptom inventory with responses scored on a Likert scale | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac anxiety as measured by the Cardiac Anxiety Questionnaire (CAQ-R) |  | 3 months | 
| Anxiety sensitivity as measured by the Anxiety Sensitivity Index-3 (ASI-3) |  | 3 months | 
| Health related quality of life as measured by the Atrial Fibrillation Effect on Quality of Life (AFEQT) |  | 3 months | 
| Atrial fibrillation severity | Atrial fibrillation severity as measured by routine clinical ambulatory monitoring with event recorders and other routine electrocardiographic monitoring. | 3 months |