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Atrial Fibrillation, Cardiac Symptoms, and Anxiety

Primary Purpose

Atrial Fibrillation, Anxiety

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness and Interoceptive Exposure
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Mindfulness and Interoceptive Exposure

Medical care as usual

Arm Description

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

Atrial fibrillation patients will receive medical and cardiac care as usual.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 6, 2014
Last Updated
January 14, 2019
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02133365
Brief Title
Atrial Fibrillation, Cardiac Symptoms, and Anxiety
Official Title
Atrial Fibrillation, Cardiac Symptoms, and Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Suspended
Why Stopped
Changes in availability of study personnel
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness and Interoceptive Exposure
Arm Type
Active Comparator
Arm Description
Atrial fibrillation patients will receive 4-5 manualized, individualized sessions of Mindfulness and Interoceptive Exposure.
Arm Title
Medical care as usual
Arm Type
No Intervention
Arm Description
Atrial fibrillation patients will receive medical and cardiac care as usual.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness and Interoceptive Exposure
Intervention Description
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 Outcome Measure Information:
Title
Cardiac symptoms as measured by the Cardiac Symptom Questionnaire (CSQ).
Description
The CSQ is a 15 item, self-report, symptom inventory with responses scored on a Likert scale
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Cardiac anxiety as measured by the Cardiac Anxiety Questionnaire (CAQ-R)
Time Frame
3 months
Title
Anxiety sensitivity as measured by the Anxiety Sensitivity Index-3 (ASI-3)
Time Frame
3 months
Title
Health related quality of life as measured by the Atrial Fibrillation Effect on Quality of Life (AFEQT)
Time Frame
3 months
Title
Atrial fibrillation severity
Description
Atrial fibrillation severity as measured by routine clinical ambulatory monitoring with event recorders and other routine electrocardiographic monitoring.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meghan S Kolodziej, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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Atrial Fibrillation, Cardiac Symptoms, and Anxiety

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