Hypnosis for Hot Flashes: A Randomized Clinical Trial

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/收益平衡发生了变化，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，与等候名单对照相比，催眠可以显著降低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）（58-69%）。然而，催眠在减少健康绝经妇女和乳腺癌幸存者的生理测量（即生理测量的影响）潮热方面的治疗效果尚未建立相对于结构注意控制。同时，催眠减少潮热的生理机制尚不清楚。然而，通过减轻压力，催眠可以间接降低下丘脑-垂体-肾上腺（HPA）的活性。皮质醇是最被广泛接受的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，催眠治疗潮热的潜在调节因子以前也没有被研究过。潜在的调节因素可能包括可催眠性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治疗潮热的变量。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。

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.