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: 10227965
• 负责人: DEBRA L. BARTON
• 金额: $ 67.01万
• 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 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10227965
• 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; 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; 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; efficacy evaluation; 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.

抽象的 潮热对 80% 或更多因衰老而经历更年期的女性产生负面影响 和/或乳腺癌的诊断和治疗，导致情绪和身体作用下降 发挥作用。治疗潮热最有效的方法是基于雌激素的治疗​​，要么是禁忌的，要么是 由于癌症和严重副作用的风险，许多女性感到担忧。一些非雌激素 已发现基于基础的治疗有效，但它们也可能具有负的风险收益比。有效的， 针对潮热的非激素治疗不会产生不良副作用并且易于使用 所有女性都需要。催眠放松疗法是一种身心干预疗法，已证明 能够减少因自然衰老和乳腺癌而经历更年期的女性的潮热 治疗，最近已被北美协会添加到潮热管理的临床指南中 更年期协会。然而，由于缺乏经过培训和/或认证的人员，获得这种有效治疗的机会受到限制。 获得许可的提供商。根据国际移民组织关于妇女健康的报告，需要做出努力才能将 基于有效指南的治疗广泛付诸实践。这项研究代表了实现这一目标的下一步 关键目标。该申请提出了一项多中心、双臂、随机对照试验，涉及 224 绝经后妇女要实现以下具体目标： 1) 评估完全自我治疗的效果 与同等结构的注意力对照组相比，实施催眠； 2) 评估功效 自我管理催眠与对睡眠、情绪和潮热相关质量的结构化关注的比较 3) 通过评估有效性的中介因素和调节因素来探索潜在的机制。这 研究有可能成为广泛传播针对热点问题的强有力干预措施的门户 闪烁并阐明采取进一步干预措施的行动机制。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，并且 探索减少潮热的机制。