Hypnosis for Hot Flashes: A Randomized Clinical Trial

催眠治疗潮热：一项随机临床试验

基本信息

批准号：
8060508
负责人：
Gary R Elkins
金额：
$ 48.43万
依托单位：
BAYLOR UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-09-30 至 2015-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8060508
关键词：
Adrenal Glands Alternative Therapies Anxiety Attention Benefits and Risks Cancer Survivor Caring Cognitive Data Effectiveness of Interventions Epidemiologic Studies Equilibrium Equipment and supply inventories Expectancy Frequencies Goals Hot flushes Hour Hydrocortisone Hypnosis Hypothalamic structure Individual Individual Differences Intervention Investigation Measures Mediating Medical Medical center Menopausal Symptom Menopause Mental Depression Mind-Body Intervention Monitor Nurses Outcome Outcome Measure Participant Patient Self-Report Perception Physiologic Monitoring Physiological Pituitary Gland Postmenopause Predisposition Psychological Factors Psychological Stress Questionnaires Randomized Randomized Clinical Trials Recruitment Activity Relative (related person)Research Research Personnel Role Sampling Severities Sex Functioning Site Sleep Stress Structure Sympathetic Nervous System Symptoms Testing Treatment Effectiveness United States Visual Waiting Lists Woman Women&apos s Health aging population alternative treatment analog clinical practice design diaries effective intervention effective therapy expectation experience follow-up hormone therapy hypnotic hypothalamic-pituitary-adrenal axis improved indexing innovation interest intervention effect malignant breast neoplasm novel post intervention programs psychologic response trait

项目摘要

DESCRIPTION (provided by applicant): Context: Hot flashes are the most severe and frequent menopausal symptom experienced by postmenopausal women and breast cancer survivors. Findings from the Women's Health Initiative that indicate a shift in the risk/benefit balance of hormone therapy has created a pressing need for effective alternative therapies for hot flashes. Our preliminary data indicate that hypnosis can significantly reduce (58-69%) subjectively measured, self-reported hot flash frequency, severity, and interference (i.e. perceived impact) in breast cancer survivors relative to a wait-list control. However, the treatment effectiveness of hypnosis in reducing physiologically measured (i.e. physiologically measured impact) hot flashes with both healthy menopausal women and breast cancer survivors has yet to be established relative to a Structured-Attention Control. [Also, the physiologic mechanism by which hypnosis may operate in reducing hot flashes is unknown. However, by reducing stress hypnosis may indirectly decrease hypothalamic-pituitary-adrenal (HPA) activity. Cortisol is one of the most widely accepted indicators of HPA activity and it is unknown if hypnosis may decrease cortisol in women experiencing hot flashes.] Also, potential moderators of the efficacy of hypnosis for hot flashes have not been previously studied. Potential moderators may include individual differences in hypnotizability and cognitive expectations for the intervention effectiveness. To our knowledge no previous research has investigated expectancy as a variable regarding any treatment of hot flashes. We hypothesize that hypnosis is a well-tolerated effective intervention to decrease hot flashes in women who are hypnotizable. Objective: (1) Determine the effect of hypnosis intervention on reducing hot flash frequency and severity (perceived impact vs. physiologically measured impact) in menopausal women and breast cancer survivors; (2) Investigate potential moderators of the intervention's effectiveness including cognitive expectancies and hypnotizability scores. (3) Investigate effects of the hypnosis intervention on anxiety, depression, sexual function, sleep quality, and [stress (cortisol).] Design: A stratified randomized design will compare the intervention in menopausal women and breast cancer survivors to an attention-control condition. [Follow-up will be at 12 weeks post-baseline.] Setting and Participants: 200 participants experiencing [7 moderate to severe hot flashes per day or 50 hot flashes weekly] will be recruited from major medical centers in the Eastern and Southwest United States. Intervention: Participants will be randomly assigned to receive five individual sessions of hypnosis or five sessions of structured attention-control condition. Main Outcome Measures: Outcomes will be hot flashes (self-report daily diaries; physiological monitoring; hot flash daily interference), anxiety (State-Trait Anxiety Inventory, VAS ratings), depression (CES-D), sexual function (Sexual Function Scale), sleep quality (Pittsburgh Sleep Quality Index), stress (cortisol), cognitive expectancies (VAS ratings) and hypnotizability (Stanford Hypnotic Susceptibility Scale Form C). If successful, the results of the proposed study will allow for a new non-pharmacological intervention for hot flashes and make novel theoretical contributions to examining the psychological factors that may be associated with changes in hot flashes.

描述（由申请人提供）：背景：潮热是绝经后妇女和乳腺癌幸存者经历的最严重和最常见的更年期症状。妇女健康倡议的研究结果表明，激素治疗的风险/效益平衡发生了变化，迫切需要有效的潮热替代疗法。我们的初步数据表明，相对于等待名单对照，催眠可以显着降低（58-69%）乳腺癌幸存者主观测量、自我报告的潮热频率、严重程度和干扰（即感知影响）。然而，相对于结构化注意力控制，催眠在减少健康更年期妇女和乳腺癌幸存者的生理测量（即生理测量影响）潮热方面的治疗效果尚未确定。 [此外，催眠减少潮热的生理机制尚不清楚。然而，通过减少压力，催眠可能会间接降低下丘脑-垂体-肾上腺（HPA）的活性。皮质醇是最广泛接受的 HPA 活性指标之一，目前尚不清楚催眠是否会降低经历潮热的女性的皮质醇。]此外，催眠治疗潮热功效的潜在调节因素以前尚未研究过。潜在的调节因素可能包括催眠能力的个体差异和对干预效果的认知期望。据我们所知，之前没有研究将预期作为任何潮热治疗的变量进行调查。我们假设催眠是一种耐受性良好的有效干预措施，可减少可催眠女性的潮热。目的：（1）确定催眠干预对减少绝经期妇女和乳腺癌幸存者潮热频率和严重程度（感知影响与生理测量影响）的效果； (2) 研究干预效果的潜在调节因素，包括认知预期和催眠性评分。 (3) 调查催眠干预对焦虑、抑郁、性功能、睡眠质量和[压力（皮质醇）]的影响。设计：分层随机设计将对更年期妇女和乳腺癌幸存者的干预与注意力控制条件进行比较。 [随访将在基线后 12 周进行。] 地点和参与者：将从美国东部和西南部的主要医疗中心招募 200 名经历过[每天 7 次中度至重度潮热或每周 50 次潮热]的参与者。干预：参与者将被随机分配接受五次单独的催眠治疗或五次结构化注意力控制条件治疗。主要结果测量：结果将是潮热（自我报告每日日记；生理监测；潮热日常干扰）、焦虑（状态特质焦虑量表、VAS评分）、抑郁（CES-D）、性功能（性功能量表））、睡眠质量（匹兹堡睡眠质量指数）、压力（皮质醇）、认知预期（VAS 评级）和催眠能力（斯坦福催眠协会）敏感性量表表 C)。如果成功，拟议研究的结果将允许对潮热进行新的非药物干预，并为检查可能与潮热变化相关的心理因素做出新的理论贡献。