Mindfullness-Based Stress Reduction for Hot Flashes

描述（由申请人提供）：大多数女性在绝经过渡期都会出现血管痉挛症状（VMS），如潮热（HF）和盗汗，少数人会出现相当大的痛苦和角色功能下降。直到最近，大多数妇女通过激素治疗（HT）得到缓解，但对HT相关健康风险的担忧使妇女除了自己的应对策略外，几乎没有有效和安全的选择来缓解症状。来自人群和实验室研究的各种结果表明，压力和HF是相关的，HF在应对能力较低的女性中更严重，但证据远非结论性的。因此，研究人员呼吁进行试验以评估减压干预对HF的影响。正念减压（MBSR）是一种广泛使用的手动程序，被证明是一种有效的连续干预措施，可以减少各种压力相关疾病的医学症状和心理困扰。在一项使用正念减压疗法的小型初步研究中，我们发现HF严重程度评分降低，与更年期相关的生活质量（QOL）提高。这项R21提案是针对120名每天经历7次或更多次中度至重度HF的绝经期妇女进行的MBSR与等待名单对照组的初步随机试验。其目的是：1）评估招募的可行性、对项目干预的依从性和对评估工具的依从性，为更大规模的RCT做准备; 2）提供MBSR在降低自我报告的HF频率和强度以及改善QOL方面的疗效的初步估计。此外，我们将在每组10名女性的亚组中使用胸骨皮肤电导作为VMS的既定客观指标，以测试可行性并获得关于客观测量的HF与自我报告的HF在这种情况下如何相关的信息。女性将在基线、八周正念减压疗法课程结束时和课程结束后三个月进行评估。第二个目的是探讨治疗组HF频率和强度以及QOL变化的差异是否可以通过感知压力、健康相关控制点和正念的变化来解释。预计这项初步研究的结果将提供计划一项更大更明确的随机试验所需的数据，该试验旨在研究正念减压疗法对HF频率和强度的影响以及科普这些症状的能力。

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.