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

自我催眠治疗治疗女性潮热：一项随机临床试验

• 批准号: 9761461
• 负责人: DEBRA L. BARTON
• 金额: $ 69.77万
• 依托单位: BAYLOR UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-22 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9761461
• 关键词: Academy; Address; Adherence; Age; Aging; American; Attention; Behavioral; Breast Cancer Treatment; Breast Cancer survivor; Caring; Chronic Disease; Circadian Rhythms; Clinical; Cognitive Therapy; Control Groups; Development; Diagnosis; Distress; Effectiveness; Emotional; Estrogens; Female; Frequencies; Functional disorder; Goals; Guidelines; Health; Home environment; Hot flushes; Hour; Hydrocortisone; Hypnosis; Institute of Medicine (U.S.); Intervention; Malignant Neoplasms; Mediator of activation protein; Menopausal Symptom; Menopause; Mind-Body Intervention; Moods; Night Sweating; Perception; Pharmacology; Physiological; Population; Postmenopause; Provider; Public Health; Quality of life; Randomized Clinical Trials; Randomized Controlled Trials; Recording of previous events; Relaxation; Relaxation Therapy; Reporting; Research; Rest; Risk; Role; Salivary; Self Administration; Self Efficacy; Severities; Site; Sleep; Societies; Structure; Symptoms; Training; Translating; Treatment Efficacy; Vasomotor; Woman; Women' s Health; Work; adherence rate; arm; attentional control; base; effective intervention; effective therapy; experience; heart rate variability; high risk; hypnotic; improved; innovation; malignant breast neoplasm; preference; primary outcome; programs; risk benefit ratio; secondary outcome; side effect

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.

摘要 潮热对80%或更多的女性人口由于衰老而经历更年期产生负面影响 和/或乳腺癌的诊断和治疗，导致情感和身体作用的减少， 功能最有效的治疗潮热，雌激素为基础的治疗，要么禁忌， 由于癌症和严重的副作用风险，这是许多妇女担心的原因。一些非雌激素 基础治疗已被发现是有效的，但它们也可能具有负面的风险效益比。有效， 用于潮热的非激素治疗，与不必要的副作用无关， 所有女人都需要。催眠放松疗法是一种身心干预，已经证明了 能够减少自然衰老和乳腺癌导致的更年期妇女的潮热 治疗，最近已被添加到临床指南潮热管理由北美 更年期协会。然而，由于缺乏训练有素和/或经过认证的医生， 持牌供应商。根据国际移民组织关于妇女健康的一份报告， 有效的基于指南的治疗方法广泛应用于实践。这项研究代表了满足这一要求的下一步， 关键目标。本申请提出了一项多中心、两组、随机对照试验， 绝经后妇女，以实现以下具体目标：1）评价疗效的完全自我， 管理催眠与同等结构的注意力控制组相比; 2）评估 自我管理催眠与结构化注意力在睡眠、情绪和潮热相关质量方面的比较 3）通过评估有效性的中介者和调节者来探索潜在的机制。这 研究有可能成为广泛传播一种强有力的干预措施的门户， 闪光和阐明行动机制，在此基础上建立进一步的干预措施。本研究 创新，因为它寻求以完全自我管理的方式提供提供提供者强化治疗， 探索它减少潮热的机制。