Atrial Fibrillation, Cardiac Symptoms, and Anxiety

Not Applicable

Suspended

• Conditions: Atrial Fibrillation; Anxiety
• Interventions: Behavioral: Mindfulness and Interoceptive Exposure

• Registration Number: NCT02133365
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-05-06
• Study First Submitted QC: 2014-05-07
• Study First Posted: 2014-05-08
• Study Start: 2014-09
• Primary Completion: 2017-03
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-15
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness and Interoceptive Exposure	Mindfulness and Interoceptive Exposure	Atrial fibrillation patients will receive 4-5 manualized, individualized sessions of Mindfulness and Interoceptive Exposure.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	3 months	Atrial fibrillation severity as measured by routine clinical ambulatory monitoring with event recorders and other routine electrocardiographic monitoring.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States