A mindfulness-based intervention for treatment of anxiety in ICD patients

描述（由申请人提供）：在一级和二级预防试验中，植入式心脏转复除颤器（ICD）已被证明可以降低心脏死亡的风险，但人们对植入式心脏转复除颤器患者的生活质量（QOL）和心理健康状况提出了担忧。焦虑已被证明是缺血性心脏病死亡率的独立预测因子，这提高了它可能在ICD患者观察到的高一年死亡率中起促进作用的可能性。以正念为基础的干预是一种复杂的行为干预，结合了呼吸和轻瑜伽练习，已被证明可以减少焦虑和一些身体症状，如癌症、慢性疼痛、类风湿关节炎和纤维肌痛。有一些初步证据表明，以正念为基础的干预也可能减少心脏病患者的焦虑。可以假设，以正念为基础的训练可以减少ICD患者的焦虑，从而减少心律失常/心脏事件和ICD带来的电击的数量。我们决定在一组ICD植入候选患者中，通过一项基于手机的正念干预和常规护理的初步研究来验证这一假设。这项试点研究将提供初步数据，说明招募、保留和坚持以正念为基础的电话传递干预治疗ICD患者焦虑的可行性，并初步估计正念水平、焦虑、休克和心律失常发作的疗效。该研究将在马萨诸塞州伍斯特的麻省大学纪念医疗中心（UMMC）进行，每年有300多名患者入院接受ICD植入。所有连续的门诊患者将被筛选参与研究。符合条件的患者将被同意并随机分配到常规护理组或正念训练组。总共52名患者（每个人26名）将被纳入研究。干预将包括一次在医院进行的一对一正念训练课程，随后是每周七次的电话授课课程，由一位经过认证的正念教练授课。焦虑和正念得分将在基线和入组后12周进行测量。

DESCRIPTION (provided by applicant): Implantable cardioverter-defibrillators (ICD) have been demonstrated to reduce the risk of cardiac death both in primary and secondary prevenfion trials, but concerns have been raised regarding the quality of life (QOL) and psychological well-being in ICD-implanted patients. Anxiety has been shown to be an independent predictor of mortality in ischemic heart disease raising the possibility that it may play a contributing role in the high one-year mortality rate observed in ICD patients. Mindfulness-based interventions are complex behavioral interventions combining breathing and light yoga exercises that have been shown to reduce anxiety and some physical symptoms in conditions such as cancer, chronic pain, rheumatoid arthritis and fibromyalgia. There is some preliminary evidence that mindfulness-based interventions may reduce anxiety in cardiac patients as well. It is possible to hypothesize that a mindfulness- based training may reduce anxiety in ICD patients and, consequently, lead to a reduction in the number of arrhythmic/cardiac events and ICD-delivered shocks. We decided to test this hypothesis in a pilot study of a phone delivered, mindfulness based intervention compared to usual care in a group of candidates for ICD implantation. This pilot study will provide preliminary data about the feasibility of recruitment, retention, and adherence to a mindfulness based, phone delivered intervention for treatment of anxiety in ICD patients, and preliminary estimates of efficacy on mindfulness level, anxiety, shocks and arrhythmic episodes. The Study will be conducted at UMass Memorial Medical Center (UMMC) in Worcester, MA where more than 300 patients are admitted every year for ICD implantation. All consecutive outpatients will be screened for study participation. Eligible patients will be consented and randomized either to a usual care arm, or to a mindfulness-training arm. A total of 52 patients (26 for each amn) will be enrolled in the study. The intervention will include one in-hospital, one-to-one mindfulness training session, followed by seven weekly, individual, phone-delivered sessions with a certified mindfulness instructor. Anxiety and mindfulness scores will be measured at baseline and 12 weeks after enrollment. Public Health Relevance: This project is relevant to public health because the number of candidates for ICD implantation is rising due to a broadening of indications to include primary prevention of sudden death. The prevalence of anxiety in this population reaches up to 40% in some Studies. A mindfulness-based intervention, adapted to this group of patients, is relatively inexpensive and, once learned, can easily be self-administered by the patient. If proven effective, it could positively impact the quality of life and, possibly, the incidence of arrhythmias and delivered shocks in these patients.