Self-administered hypnosis treatment for the management of hot flashes in women: A randomized clinical trial

摘要 潮热对80%或更多因年龄增长而经历更年期的女性人口产生负面影响 和/或乳腺癌的诊断和治疗，导致情感和身体作用的下降 功能正常。治疗潮热最有效的治疗方法是以雌激素为基础的治疗，要么禁忌，要么 由于癌症和严重的副作用风险，这是许多女性担心的原因。一些非雌激素 基于基础的治疗已经被发现是有效的，但它们也可能具有负的风险-收益比。有效的， 潮热的非激素治疗，不会产生不想要的副作用，而且可以获得 对所有女性来说都是必要的。催眠放松疗法是一种身心干预，它证明了 减少因自然衰老和乳腺癌而绝经的女性潮热的能力 治疗，最近被添加到北美的潮热管理临床指南中 更年期协会。然而，由于缺乏培训和/或认证，获得这一有效治疗的机会受到限制。 有执照的提供商。根据国际移民组织关于妇女健康的一份报告，需要努力才能将 有效的基于指南的治疗广泛应用于实践。这项研究代表着实现这一目标的下一步 关键目标。本申请提出了一项多点、双臂、随机对照试验，共224例 绝经后妇女要达到以下具体目标：1)评价自我效能 实施催眠与同等注意结构对照组的比较；2)评估催眠的效果 自我催眠与结构化注意对睡眠、情绪和潮热相关质量的比较 3)通过评估调解人和调解人的有效性来探索潜在的机制。这 研究有可能成为广泛传播针对热的强大干预措施的门户 并阐明进一步干预措施所依据的行动机制。这项研究是 创新是因为它寻求以完全自我管理的方式提供提供者强化治疗，并 探索它减少潮热的机制。

Abstract Hot flashes negatively impact 80% or more of the female population experiencing menopause due to aging and/or diagnosis and treatment for breast cancer, causing decreases in both emotional and physical role functioning. The most effective treatment for hot flashes, estrogen based treatment, is either contraindicated or a cause for worry amongst many women due to cancer and serious side effect risks. Some non-estrogen based treatments have been found effective, but they also can have a negative risk-benefit ratio. Effective, non-hormonal treatments for hot flashes that are not associated with unwanted side effects and are accessible to all women are needed. Hypnotic relaxation therapy is a mind-body intervention that has demonstrated the ability to reduce hot flashes in women experiencing menopause from natural aging as well as breast cancer treatment and has recently been added to a clinical guideline for hot flash management by the North American Menopause Society. However, access to this effective treatment is limited by a lack of trained and/or certified licensed providers. According to an IOM report on women’s health, efforts are needed to be able to translate effective guideline based treatments broadly into practice. This study represents the next step to meet that critical objective. This application proposes a multi-site, two arm, randomized controlled trial with 224 postmenopausal women to accomplish the following specific aims: 1) Evaluate efficacy of a fully self- administered hypnosis compared to an equivalently structured attention control group; 2) Evaluate efficacy of the self-administered hypnosis compared to structured attention for sleep, mood, and hot flash related quality of life, and 3) Explore potential mechanisms by assessing mediators and moderators of effectiveness. This research has the potential to be the gateway to the broad dissemination of a powerful intervention against hot flashes and to illuminate mechanisms of action upon which to build further interventions. This study is innovative because it seeks to deliver a provider intensive therapy in a fully self-administered way, and to explore mechanisms by which it reduces hot flashes.