Atrial Fibrillation, Cardiac Symptoms, and Anxiety

NCT02133365 | Completed

• 1 other identifier: 2014P000363
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Mindfulness and Interoceptive Exposure

ACTIVE COMPARATOR

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

Behavioral: Mindfulness and Interoceptive Exposure

Medical care as usual

NO INTERVENTION

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

Interventions

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.

Mindfulness and Interoceptive Exposure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (15)

• Van Gelder IC, Hagens VE, Bosker HA, Kingma JH, Kamp O, Kingma T, Said SA, Darmanata JI, Timmermans AJ, Tijssen JG, Crijns HJ; Rate Control versus Electrical Cardioversion for Persistent Atrial Fibrillation Study Group. A comparison of rate control and rhythm control in patients with recurrent persistent atrial fibrillation. N Engl J Med. 2002 Dec 5;347(23):1834-40. doi: 10.1056/NEJMoa021375.

  PMID: 12466507 BACKGROUND

• Hagens VE, Vermeulen KM, TenVergert EM, Van Veldhuisen DJ, Bosker HA, Kamp O, Kingma JH, Tijssen JG, Crijns HJ, Van Gelder IC; RACE study group. Rate control is more cost-effective than rhythm control for patients with persistent atrial fibrillation--results from the RAte Control versus Electrical cardioversion (RACE) study. Eur Heart J. 2004 Sep;25(17):1542-9. doi: 10.1016/j.ehj.2004.06.020.

  PMID: 15342174 BACKGROUND

• Gehi AK, Sears S, Goli N, Walker TJ, Chung E, Schwartz J, Wood KA, Guise K, Mounsey JP. Psychopathology and symptoms of atrial fibrillation: implications for therapy. J Cardiovasc Electrophysiol. 2012 May;23(5):473-8. doi: 10.1111/j.1540-8167.2011.02264.x. Epub 2012 Mar 19.

  PMID: 22429764 BACKGROUND

• Yu SB, Hu W, Zhao QY, Qin M, Huang H, Cui HY, Huang CX. Effect of anxiety and depression on the recurrence of persistent atrial fibrillation after circumferential pulmonary vein ablation. Chin Med J (Engl). 2012 Dec;125(24):4368-72.

  PMID: 23253703 BACKGROUND

• Craske MG, Barlow DH. (2007). Mastery of your anxiety and panic: Therapist guide (2nd Ed). New York, NY: Oxford University Press

  BACKGROUND

• Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.

  PMID: 16443717 BACKGROUND

• Kabat-Zinn J. (1990) Full catastrophe living: Using the wisdom of your body and mind to face stress, pain and illness. New York: Delacourt.

  BACKGROUND

• Nyklicek I, Dijksman SC, Lenders PJ, Fonteijn WA, Koolen JJ. A brief mindfulness based intervention for increase in emotional well-being and quality of life in percutaneous coronary intervention (PCI) patients: the MindfulHeart randomized controlled trial. J Behav Med. 2014 Feb;37(1):135-44. doi: 10.1007/s10865-012-9475-4. Epub 2012 Nov 23.

  PMID: 23180285 BACKGROUND

• Carlson LE, Ursuliak Z, Goodey E, Angen M, Speca M. The effects of a mindfulness meditation-based stress reduction program on mood and symptoms of stress in cancer outpatients: 6-month follow-up. Support Care Cancer. 2001 Mar;9(2):112-23. doi: 10.1007/s005200000206.

  PMID: 11305069 BACKGROUND

• Roth B, Robbins D. Mindfulness-based stress reduction and health-related quality of life: findings from a bilingual inner-city patient population. Psychosom Med. 2004 Jan-Feb;66(1):113-23. doi: 10.1097/01.psy.0000097337.00754.09.

  PMID: 14747645 BACKGROUND

• Speca M, Carlson LE, Goodey E, Angen M. A randomized, wait-list controlled clinical trial: the effect of a mindfulness meditation-based stress reduction program on mood and symptoms of stress in cancer outpatients. Psychosom Med. 2000 Sep-Oct;62(5):613-22. doi: 10.1097/00006842-200009000-00004.

  PMID: 11020090 BACKGROUND

• Ledesma D, Kumano H. Mindfulness-based stress reduction and cancer: a meta-analysis. Psychooncology. 2009 Jun;18(6):571-9. doi: 10.1002/pon.1400.

  PMID: 19023879 BACKGROUND

• Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555.

  PMID: 20350028 BACKGROUND

• Nyklicek I, Kuijpers KF. Effects of mindfulness-based stress reduction intervention on psychological well-being and quality of life: is increased mindfulness indeed the mechanism? Ann Behav Med. 2008 Jun;35(3):331-40. doi: 10.1007/s12160-008-9030-2. Epub 2008 Jun 6.

  PMID: 18535870 BACKGROUND

• Grossman P, Niemann L, Schmidt S, Walach H. Mindfulness-based stress reduction and health benefits. A meta-analysis. J Psychosom Res. 2004 Jul;57(1):35-43. doi: 10.1016/S0022-3999(03)00573-7.

  PMID: 15256293 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Anxiety Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Meghan S Kolodziej, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Psychiatrist

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 8, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: January 1, 2020
• Last Updated: November 6, 2025

Record last verified: 2025-11

Locations

US (1)