Atrial FibrillationNCT02133365
Atrial Fibrillation, Cardiac Symptoms, and Anxiety
A study testing Mindfulness and Interoceptive Exposure in people with Atrial Fibrillation and Anxiety, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Anxiety
- What is being tested?
- Mindfulness and Interoceptive Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation, Anxiety
- Being tested
- Mindfulness and Interoceptive Exposure
- Medical subject headings
- Atrial Fibrillation, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness and Interoceptive ExposureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness and Interoceptive Exposure | Active comparator | Atrial fibrillation patients will receive 4-5 manualized, individualized sessions of Mindfulness and Interoceptive Exposure. Receives: Behavioral: Mindfulness and Interoceptive Exposure |
| Medical care as usual | No intervention | Atrial fibrillation patients will receive medical and cardiac care as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (4)
Cardiac anxiety as measured by the Cardiac Anxiety Questionnaire (CAQ-R)
Measured: 3 months
Anxiety sensitivity as measured by the Anxiety Sensitivity Index-3 (ASI-3)
Measured: 3 months
Health related quality of life as measured by the Atrial Fibrillation Effect on Quality of Life (AFEQT)
Measured: 3 months
Atrial fibrillation severity
Atrial fibrillation severity as measured by routine clinical ambulatory monitoring with event recorders and other routine electrocardiographic monitoring.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2017
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meghan Kolodziej, Brigham and Women's Hospital
- Investigators
- Meghan S Kolodziej, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133365
- Sponsor's protocol ID
- 2014P000363
- Status last verified
- Nov 2025
- First submitted
- 6 May 2014
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12466507Hagens 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.
PubMed 15342174Gehi 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.
PubMed 22429764Yu 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.
PubMed 23253703Craske MG, Barlow DH. (2007). Mastery of your anxiety and panic: Therapist guide (2nd Ed). New York, NY: Oxford University Press
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.
PubMed 16443717Kabat-Zinn J. (1990) Full catastrophe living: Using the wisdom of your body and mind to face stress, pain and illness. New York: Delacourt.
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.
PubMed 23180285Carlson 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.
PubMed 11305069Roth 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.
PubMed 14747645Speca 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.
PubMed 11020090Ledesma D, Kumano H. Mindfulness-based stress reduction and cancer: a meta-analysis. Psychooncology. 2009 Jun;18(6):571-9. doi: 10.1002/pon.1400.
PubMed 19023879Hofmann 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.
PubMed 20350028Nyklicek 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.
PubMed 18535870Grossman 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.
PubMed 15256293
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation, Cardiac Symptoms, and Anxiety
- ClinicalTrials.gov ID
- NCT02133365
- Acronym / sponsor ID
- 2014P000363
- Conditions
- Atrial Fibrillation, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 8 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness and Interoceptive Exposure | Active comparator | Behavioral: Mindfulness and Interoceptive ExposureAtrial 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness and Interoceptive ExposureThe 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. | Behavioural | Mindfulness and Interoceptive Exposure |
Primary outcome
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
4 secondary outcomes
Cardiac anxiety as measured by the Cardiac Anxiety Questionnaire (CAQ-R)
Time frame: 3 months
Anxiety sensitivity as measured by the Anxiety Sensitivity Index-3 (ASI-3)
Time frame: 3 months
Health related quality of life as measured by the Atrial Fibrillation Effect on Quality of Life (AFEQT)
Time frame: 3 months
Atrial fibrillation severity
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Background: PubMed 12466507Van 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.
- Background: PubMed 15342174Hagens 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.
- Background: PubMed 22429764Gehi 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.
- Background: PubMed 23253703Yu 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.
- BackgroundCraske MG, Barlow DH. (2007). Mastery of your anxiety and panic: Therapist guide (2nd Ed). New York, NY: Oxford University Press
- Background: PubMed 16443717Baer 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.
- BackgroundKabat-Zinn J. (1990) Full catastrophe living: Using the wisdom of your body and mind to face stress, pain and illness. New York: Delacourt.
- Background: PubMed 23180285Nyklicek 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.
- Background: PubMed 11305069Carlson 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.
- Background: PubMed 14747645Roth 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.
- Background: PubMed 11020090Speca 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.
- Background: PubMed 19023879Ledesma D, Kumano H. Mindfulness-based stress reduction and cancer: a meta-analysis. Psychooncology. 2009 Jun;18(6):571-9. doi: 10.1002/pon.1400.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meghan S Kolodziej, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and Interoceptive Exposure in people with Atrial Fibrillation and Anxiety, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac symptoms as measured by the Cardiac Symptom Questionnaire (CSQ). (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02133365, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.