Hypnosis for Hot Flashes: A Randomized Clinical Trial

催眠治疗潮热：一项随机临床试验

• 批准号: 7807020
• 负责人: Gary R Elkins
• 金额: $ 49.63万
• 依托单位: BAYLOR UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-30 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7807020
• 关键词: Adrenal Glands; Alternative Therapies; Anxiety; Arts; Attention; Benefits and Risks; Cancer Survivor; Caring; Cognitive; Data; Effectiveness of Interventions; Epidemiologic Studies; Equilibrium; Equipment and supply inventories; Expectancy; Frequencies; Future; Goals; Hot flushes; Hour; Hydrocortisone; Hypnosis; Hypothalamic structure; Individual; Individual Differences; Intervention; Investigation; Knowledge; 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' 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

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绝经期症状。来自妇女健康倡议的调查结果表明，激素治疗的风险/效益平衡发生了变化，迫切需要有效的替代疗法来治疗潮热。我们的初步数据表明，催眠可以显着减少（58-69%）主观测量，自我报告的潮热频率，严重程度和干扰（即感知的影响）在乳腺癌幸存者相对于等待名单控制。然而，催眠在减少健康绝经期妇女和乳腺癌幸存者的生理测量（即生理测量的影响）潮热方面的治疗有效性相对于结构化注意力控制尚未确定。[Also催眠在减少潮热中的生理机制尚不清楚。然而，通过减轻压力催眠可能间接降低下丘脑-垂体-肾上腺（HPA）的活动。皮质醇是最广泛接受的HPA活性指标之一，尚不清楚催眠是否会降低潮热女性的皮质醇。此外，催眠对潮热疗效的潜在调节剂以前也没有研究过。潜在的调节因素可能包括催眠能力和对干预有效性的认知期望的个体差异。据我们所知，没有以前的研究调查预期作为一个变量，关于任何治疗潮热。我们假设催眠是一种耐受性良好的有效干预措施，可以减少可催眠女性的潮热。 目的：（1）确定催眠干预对减少更年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）的影响;（2）调查干预有效性的潜在调节因素，包括认知预期和催眠评分。(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。 设计图：分层随机设计将比较绝经妇女和乳腺癌幸存者的干预措施与注意力控制条件。[将在基线后12周进行随访。] 环境和参与者：将从美国东部和西南部的主要医学中心招募200名经历[每天7次中度至重度潮热或每周50次潮热]的参与者。 干预措施：参与者将被随机分配接受五次单独的催眠或五次结构化注意力控制条件。 主要结局指标：结局为潮热（自我报告每日日记;生理监测;潮热每日干扰）、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）、应激（皮质醇）、认知预期（VAS评分）和催眠能力（斯坦福大学催眠易感性量表C型）。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。