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，植入式心律转复除颤器（ICD）已被证明可降低心源性死亡的风险，但植入ICD患者的生活质量（QOL）和心理健康受到了关注。焦虑已被证明是缺血性心脏病死亡率的独立预测因子，这增加了它可能在ICD患者的高1年死亡率中发挥作用的可能性。基于正念的干预是一种复杂的行为干预，结合了呼吸和轻度瑜伽练习，已被证明可以减少癌症，慢性疼痛，类风湿性关节炎和纤维肌痛等疾病的焦虑和一些身体症状。有一些初步证据表明，基于正念的干预措施也可以减少心脏病患者的焦虑。可以假设，基于正念的训练可以减少ICD患者的焦虑，因此，减少了心律失常/心脏事件和ICD输送电击的数量。我们决定在一项试点研究中测试这一假设，该研究将一组ICD植入候选人的电话传递、基于正念的干预与常规护理进行了比较。这项试点研究将提供关于招募、保留和坚持基于正念的电话递送干预治疗ICD患者焦虑的可行性的初步数据，以及对正念水平、焦虑、电击和癫痫发作的疗效的初步估计。本研究将在马萨诸塞州伍斯特市的马萨诸塞大学纪念医学中心（UMMC）进行，该中心每年有300多名患者入院接受ICD植入。将筛选所有连续门诊患者参加研究。符合条件的患者将获得知情同意，并随机分配至常规护理组或正念训练组。共有52例患者（每组26例）将入组本研究。干预将包括一次住院的一对一正念培训课程，然后是七次每周一次的个人电话培训课程，由一位经过认证的正念导师授课。将在基线和入组后12周测量焦虑和正念评分。 公共卫生相关性：该项目与公共卫生相关，因为随着适应症的扩大，包括猝死的一级预防，ICD植入的候选人数正在增加。在一些研究中，这一人群的焦虑患病率高达40%。适合这类患者的正念干预相对便宜，一旦学会，患者可以很容易地自我管理。如果证明有效，它可能会对这些患者的生活质量产生积极影响，并可能降低心律失常和电击的发生率。

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.