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Completed

NCT Number: NCT02133365

Atrial Fibrillation, Cardiac Symptoms, and Anxiety

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness and Interoceptive Exposure

Behavioral

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.

Primary outcomes

  1. Cardiac symptoms as measured by the Cardiac Symptom Questionnaire (CSQ).

    Time frame: 3 months

    The CSQ is a 15 item, self-report, symptom inventory with responses scored on a Likert scale

Secondary outcomes

  1. Cardiac anxiety as measured by the Cardiac Anxiety Questionnaire (CAQ-R)

    Time frame: 3 months

  2. Anxiety sensitivity as measured by the Anxiety Sensitivity Index-3 (ASI-3)

    Time frame: 3 months

  3. Health related quality of life as measured by the Atrial Fibrillation Effect on Quality of Life (AFEQT)

    Time frame: 3 months

  4. Atrial fibrillation severity

    Time frame: 3 months

    Atrial fibrillation severity as measured by routine clinical ambulatory monitoring with event recorders and other routine electrocardiographic monitoring.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2020
First posted
May 8, 2014
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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