Hypnosis to improve sleep in menopause: Determination of optimal dose and method

催眠改善更年期睡眠：最佳剂量和方法的确定

• 批准号: 8851523
• 负责人: Gary R Elkins
• 金额: $ 20.83万
• 依托单位: BAYLOR UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-01 至 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8851523
• 关键词: Address; Adherence; Adverse effects; Adverse event; Affect; Age; American; Cardiovascular Diseases; Clinical Trials; Collaborations; Data; Diabetes Mellitus; Dose; Dropout; Emergency department visit; Endogenous Factors; Enrollment; Environment; Ethnic Origin; Exogenous Factors; Goals; Health; Healthcare; Home environment; Hot flushes; Hour; Human Resources; Hypnosis; Intervention; Knowledge; Laboratories; Life; Link; Measurement; Measures; Menopausal Status; Menopausal Symptom; Menopause; Methods; Morbidity - disease rate; National Center for Complementary and Alternative Medicine; Pain; Participant; Patient Self-Report; Pharmaceutical Preparations; Postmenopause; Prevalence; Productivity; Public Health; Quality of life; Questionnaires; Race; Randomized Clinical Trials; Randomized Controlled Trials; Recording of previous events; Reporting; Research; Research Design; Risk; Severities; Site; Sleep; Sleep Disorders; Sleep disturbances; Sleeplessness; Socioeconomic Status; Staging; Symptoms; Testing; Treatment Protocols; Woman; Work; Wrist; actigraphy; alternative treatment; design; diaries; hormone therapy; improved; innovation; malignant breast neoplasm; middle age; mortality; obesity risk; post intervention; primary outcome; programs; public health relevance; satisfaction; secondary outcome; statistics; success; trend

DESCRIPTION (provided by applicant): Poor sleep is among the most frequent, yet least addressed, health concern among women during the menopause transition and the prevalence of poor sleep increases with age. In addition, poor sleep has been associated with increased risks for other health problems, adverse effects of prescription sleep medications, and mortality; affecting the quality of life and health of midlife women. Our laboratory has identified that hypnosis, when delivered with five (5), therapist delivered, individualized hypnosis inductions can improve self- reported sleep quality among postmenopausal women presenting with a primary complaint of hot flashes. However, as currently developed, hypnosis is labor intensive and not easily disseminable, thus, limiting its potential public health impact. If a hypnosis program could be developed that is less personnel-intensive and more easily disseminable, it could have a large public health impact on the sleep of midlife women. In addition, the potential impact of any hypnosis program on objectively measured sleep has not yet been examined and there is little data for effect size estimates. Our long range goal is to identify a safe, efficacius, and widely disseminable hypnosis intervention for the treatment of sleep problems during the menopause transition. The purpose of this application is to determine the optimal dose and delivery method for a hypnosis program that shows feasibility, acceptable adherence, and preliminary effects on sleep (primary outcomes) and other secondary outcomes (sleep quality, insomnia symptom severity, daytime sleepiness, menopausal symptoms, and pain). We will enroll 80 menopausal women into a 2X2 factorial design to compare two dosing (three vs. five sessions) and two delivery methods of hypnosis (audio recorded vs. therapist delivered inductions) with assessments at baseline and four, six, and eight weeks post-intervention. Specific aims are to (1) Determine the feasibility of and adherence to the four hypnosis programs; (2) Determine initial effect sizes for the primary outcome of objectively measured sleep duration, including the percent of women who achieve a clinically meaningful improvement; (3) Determine initial effect sizes for secondary outcomes of sleep quality, insomnia symptom severity, daytime sleepiness, menopausal symptoms, and pain; and (4) Trends in potential covariates including endogenous factors (e.g., age, race/ethnicity, menopausal stage) and exogenous factors (e.g., sleep environment, socioeconomic status). Statistical analysis will determine feasibility (< 25% dropout; rating of "good" or better for the program, and <5% adverse events) and adherence (> 75% compliance with daily at-home practice). Estimated effect sizes for primary and secondary outcomes will be calculated using standard methods and the optimal programs identified (e.g., a >b>c>d). Trends in potential covariates will be analyzed using Pearson correlations for continuous covariates (e.g., age), and for categorical covariates (e.g., demographic/environment variables) t tests or ANOVAs will be conducted, as appropriate. Findings will provide the requisite data to plan a subsequent R01 application for a multi-site, large-scale, randomized controlled trial.

描述（由申请人提供）：睡眠不良是在上级过渡期间妇女最常见，最少的健康问题之一，而睡眠不良的患病率随着年龄的增长而增加。此外，睡眠不佳与其他健康问题的风险增加有关，处方睡眠药物的不利影响和死亡率；影响中年妇女的生活质量和健康。我们的实验室已经确定，当催眠术提供五（5）次治疗师时，催眠师可以改善绝经后妇女的自我报告的睡眠质量，这些妇女表现出对热闪光的主要抱怨。但是，正如目前开发的那样，催眠是劳动密集型的，因此不容易散布，因此限制了其潜在的公共卫生影响。如果可以制定较少人事密集型且更容易忽略的催眠计划，则可能对中年妇女的睡眠产生巨大的公共卫生影响。此外，尚未检查任何催眠计划对客观测量睡眠的潜在影响，并且几乎没有效果估计的数据。我们的远距离目标是确定安全，有效且广泛分发的催眠干预措施，以治疗更年期过渡期间的睡眠问题。本应用的目的是确定催眠计划的最佳剂量和输送方法，该计划显示出可行性，可接受的依从性和对睡眠（主要结局）和其他次要结果（睡眠质量，失眠，失眠症状严重程度，白天嗜睡，绝经症状以及疼痛）的初步影响（主要结局）和疼痛。我们将使80名更年期女性进入2x2阶乘设计，以比较两种剂量（3次与五个疗程）和两种催眠术（音频记录与治疗师的归纳感）与基线后的评估，四周和八周的干预后进行评估。具体目的是（1）确定对四个催眠计划的可行性和依从性； （2）确定客观测量睡眠持续时间的主要结果的初始效应大小，包括获得临床意义改善的女性百分比； （3）确定睡眠质量，失眠症状严重程度，白天嗜睡，绝经症状和疼痛的次要结果的初始效应大小； （4）潜在协变量的趋势，包括内源性因素（例如年龄，种族/种族，绝经阶段）和外源性因素（例如睡眠环境，社会经济地位）。统计分析将确定可行性（<25％的辍学；对程序的“良好”或更高的评分，<5％的不良事件）和依从性（> 75％符合每日在家实践）。将使用标准方法和确定的最佳程序（例如a> b> c> d）计算主要结果和次要结果的估计效应大小。将使用连续协变量（例如年龄）的Pearson相关性分析潜在协变量的趋势，并适当地进行t检验或ANOVAS的分类协变量（例如人口统计/环境变量）。调查结果将提供必要的数据，以计划随后的R01应用多站点，大规模，随机对照试验的应用。