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会经历血管舒缩症状（VMS），如潮热（HF）和盗汗，少数女性会经历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疗法（HT）得到缓解，但对与HT相关的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她们的症状。来自人群和实验室研究的各种结果表明，压力和心衰相关，并且心衰在应对能力较低的女性中更为严重，但证据远未得出结论性结论。因此，研究者呼吁进行试验来评估减压干预对心衰的影响。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辅助干预，可以减轻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法的小型初步研究中，我们发现HF严重程度评分降低，绝经相关生活质量（QOL）增加。这项R21提案是针对120名经历7次或以上中度至重度心力衰竭/天的绝经期妇女进行一项MBSR的试点随机试验，并与等候名单对照组进行比较。本研究旨在1)评估招募的可行性、对项目干预的依从性以及对评估工具的依从性，为更大规模的随机对照试验做准备；2)初步评估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。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的既定客观测量，以测试可行性，并获得客观测量的HF与自我报告的HF之间的关系。女性将在基线、八周正念减压课程结束时以及课程结束后三个月接受评估。第二个目的是探讨治疗组在HF频率、强度和生活质量变化方面的差异是否可以用感知压力、健康相关控制点和正念的变化来解释。预计这项试点研究的结果将提供所需的数据，以计划一项更大、更明确的随机试验，研究正念减压疗法对高频频率和强度的影响，以及对应对这些症状的能力的影响。

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.