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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness and Interoceptive Exposure | Active Comparator | Atrial fibrillation patients will receive 4-5 manualized, individualized sessions of Mindfulness and Interoceptive Exposure. |
|
| Medical care as usual | No Intervention | Atrial fibrillation patients will receive medical and cardiac care as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meghan S Kolodziej, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12466507 | Background | 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. | |
| 15342174 |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Not provided
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| 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 |
| 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. |
| 22429764 | 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. |
| 23253703 | 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. |
| Background | Craske MG, Barlow DH. (2007). Mastery of your anxiety and panic: Therapist guide (2nd Ed). New York, NY: Oxford University Press |
| 16443717 | 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. |
| 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. |
| 23180285 | 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. |
| 11305069 | 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. |
| 14747645 | 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. |
| 11020090 | 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. |
| 19023879 | 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. |
| 20350028 | 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. |
| 18535870 | 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. |
| 15256293 | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |