Mindfullness-Based Stress Reduction for Hot Flashes

描述(由申请人提供)：大多数女性在进入更年期时会出现血管运动症状(VMS)，如潮热和盗汗，还有相当一部分女性会经历相当大的痛苦和角色功能减退。直到最近，大多数女性都通过激素治疗(HT)找到了缓解的方法，但由于担心与HT相关的健康风险，女性除了自己的应对策略外，几乎没有有效和安全的缓解症状的选择。来自人群和实验室的各种研究结果都表明，压力和心力衰竭是相关的，应对能力较低的女性心力衰竭更严重，但证据远未确定。因此，研究人员呼吁进行试验，以评估减压干预对心力衰竭的效果。基于正念的压力减轻(MBSR)是一种广泛使用的手动程序，被证明是一种有效的辅助干预，可以减轻一系列与压力相关的障碍的医学症状和心理痛苦。在一项使用MBSR的小型初步研究中，我们发现心力衰竭严重程度评分降低，绝经相关生活质量(QOL)增加。这项R21建议用于MBSR的试点随机试验，与120名更年期妇女每天经历7次或更多中度到重度心力衰竭的等待名单对照组进行比较。它的目的是1)评估招募的可行性、对计划干预的坚持以及对评估工具的遵从性，为更大规模的随机对照试验做准备；2)对MBSR在降低自我报告的HF频率和强度以及改善生活质量方面的效果提供初步估计。此外，我们将使用胸骨皮肤电导作为VMS的一个既定的客观测量指标，在每只手臂的10名女性中测试可行性，并获得关于在这种设置下客观测量的HF与自我报告的HF之间的关系的信息。在为期八周的MBSR课程结束时，以及课程结束后的三个月，将对妇女进行基线评估。第二个目的是探索治疗组心力衰竭频率和强度以及生活质量变化的差异是否可以通过感知压力、与健康相关的控制点和正念的变化来解释。预计这项先导性研究的结果将提供必要的数据，以计划一项更大、更明确的随机试验，研究MBSR对HF频率和强度的影响以及应对这些症状的能力。

DESCRIPTION (provided by applicant): The majority of women experience vasomotor symptoms (VMS) such as hot flashes (HF) and night sweats as they transition through menopause, and a substantial minority experience considerable distress and diminished role functioning. Until recently most women found relief through hormone therapy (HT), but concern about the health risks associated with HT has left women with few effective and safe choices for relief from their symptoms other than their own coping strategies. A variety of results from both population and laboratory studies suggest that stress and HF are correlated and that HF are more severe in women with lower coping abilities, but evidence is far from conclusive. Consequently, investigators have called for trials to evaluate the effect of stress reduction interventions on HF. Mindfulness-Based Stress Reduction (MBSR) is a widely available manualized program shown to be an effective adjunctive intervention in reducing medical symptoms and psychological distress for a wide range of stress-related disorders. In a small preliminary study using MBSR we found reductions in HF severity scores and increases in menopause-related quality of life (QOL). This R21 proposal is for a pilot randomized trial of MBSR compared to a wait-list control group for 120 menopausal women experiencing seven or more HF/day of moderate to severe intensity. It aims to 1) assess feasibility of recruitment, adherence to program intervention, and compliance with assessment instruments in preparation for a larger RCT and 2) provide preliminary estimates of efficacy of the effects of MBSR in reducing self-reported HF frequency and intensity and improving QOL. In addition, we will use sternal skin conductance as an established objective measure of VMS in a subgroup of 10 women in each arm to test feasibility and obtain information on how the objectively measured HF are related to self reported HF in this setting. Women will be assessed at baseline, at the end of the eight-week MBSR course, and at three months after the end of the course. A secondary aim is to explore whether treatment group differences in change in HF frequency and intensity and QOL are explained by changes in perceived stress, health-related locus of control and mindfulness. It is anticipated that results from this pilot study will provide data needed to plan a larger more definitive randomized trial on the effect of MBSR on HF frequency and intensity and on the ability to cope with these symptoms.