跳至主要内容
临床试验/NCT02133365
NCT02133365已完成不适用

Atrial Fibrillation, Cardiac Symptoms, and Anxiety

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2014年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Cardiac symptoms as measured by the Cardiac Symptom Questionnaire (CSQ).

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Mindfulness and Interoceptive Exposure

Active Comparator

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

干预措施: Mindfulness and Interoceptive Exposure (Behavioral)

Medical care as usual

No Intervention

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

结局指标

主要结局

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

时间窗: 3 months

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meghan Kolodziej

Associate Psychiatrist

Brigham and Women's Hospital

研究点 (2)

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