A Feasibility Study Examining the Comparison of Transcendental Meditation Versus Health Education on Psychological and Hemodynamic Function in Post-menopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain - PROMIS Pain Interference and Pain Intensity
研究概览
简要总结
The present study will examine whether women at high risk for developing hypertension, i.e., post-menopausal status, at least mild psychological distress, and mildly elevated blood pressure, show improvements in these risk factors after a 12-week Transcendental Meditation (TM) intervention compared to Women's Health Education (WHE). Positive findings will provide initial evidence of using nonpharmacological methods, such as TM, to prevent hypertension in postmenopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •≥130 systolic blood pressure (SBP) ≤160 and/or 84 ≥ diastolic blood pressure (DBP) ≤
- •Perceived stress scale (PSS-4) > 5
- •Able to give informed consent.
- •Understand study procedures and comply with them for the length of the study.
- •Ages between 50 and 80 years.
- •Post-menopausal ≥ 1 year since last menstruation
- •Reads and speaks English
- •UHealth patients
- •Working at least part-time
排除标准
- •Currently in a meditation program.
- •Meditates more than once per week
- •Recent stroke or cerebral neurologic impairment.
- •Current uses of mood stabilizers or antipsychotics.
- •Has been diagnosed with bipolar disorder, schizophrenia, or substance use disorder.
- •Inability to give written informed consent in English.
研究组 & 干预措施
Transcendental Meditation (TM)
Participants receive a standardized Transcendental Meditation (TM) program delivered over 12 weeks by a certified instructor, including orientation, structured instruction, follow-up seminars, and daily home practice.
干预措施: Transcendental Meditation (TM) (Behavioral)
Women's Health Education (WHE)
Participants receive a structured health education program over 12 weeks focused on menopause and cardiovascular health, delivered via Zoom and WhatsApp using evidence-based materials.
干预措施: Women's Health Education (WHE) (Behavioral)
结局指标
主要结局
Pain - PROMIS Pain Interference and Pain Intensity
时间窗: Baseline, 8, 12, and 24 weeks
Patient-reported outcomes from the PROMIS system. Pain Interference items assess the extent to which pain hampers daily activities, social, and emotional functioning. Pain Intensity is assessed with a 0-10 numeric rating scale for worst, average, and current pain. Higher scores indicate greater pain burden.
Anxiety - Generalized Anxiety Disorder, GAD-7
时间窗: Baseline, 8, 12, and 24 weeks
A 7-item self-report questionnaire assessing symptoms of generalized anxiety disorder. Items are rated on a scale of 0-3 based on frequency over the past two weeks (0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day). The total score ranges from 0-21, with higher scores indicating more severe anxiety symptoms.
Stress - Perceived Stress Scale PSS-10
时间窗: Baseline, 8, 12, and 24 weeks
Validated self-reporting instrument with 10 questions on perceived stress. Each question is rated on a 5-point Likert scale ranging from 0 = never to 4 = Very Often, referring to experiences in the past month. Total scores range from 0 to 40, higher = more stress.
Depressed mood - Patient Health Questionnaire - 9, PHQ-9
时间窗: Baseline, 8, 12, and 24 weeks
A 9-item self-report measure of depressive symptoms. Each question is rated on a scale of 0 to 3, based on how often the symptom has been experienced in the past two weeks (0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day). The total score ranges from 0 to 27, higher scores indicating more severe depression.
Recruitment feasibility-The number of individuals approached vs participate.
时间窗: up to 3 years
Recruiters will record the numbers of individuals who agree to participate vs interested in hearing about the study.
Recruitment feasibility-Reasons for not participating
时间窗: up to 3 years
A checklist completed by recruiters (schedule, time commitment, topic, ineligible, other)
Attendance feasibility - Training sessions attended by TM and WHE group
时间窗: 12 weeks
Training sessions attended by the TM participants as well as the attendance and participation in videos watched for the WHE group will be recorded.
Compliance feasibility - The number of meditation sessions per week for the TM participants.
时间窗: 12 and 24 weeks
Participants in the TM group estimate in the last month how many days per week they meditated (0 = not at all, 1 = up to 3 days per week, 2 = nearly every day once per day, 3 = nearly every day twice per day)
Menopausal Symptoms - Greene Climacteric Scale (GCS)
时间窗: Baseline, 8, 12, and 24 weeks
A 21-item questionnaire assessing menopausal symptoms across four domains: psychological (anxiety/depression), somatic (aches, headaches), vasomotor (hot flashes, night sweats), and sexual function. Each item is scored 0-3 (0 = Not at all, 3 = Extremely). Total and subscale scores indicate severity of menopausal symptoms.
Fruits and Vegetables Intake
时间窗: Baseline, 8, 12, and 24 weeks
A brief dietary assessment asking participants to report the average number of daily servings of fruits and vegetables consumed. Responses are recorded as number of servings per day.
24-hour Hemodynamic Monitoring
时间窗: Baseline and 12 weeks
Continuous ambulatory monitoring using Bio-Beat patches and a Polar chest strap. Measures include systolic and diastolic blood pressure, and heart rate averaged over 24 hours. Provides objective cardiovascular data.
Stress - Perceived Stress Scale-10 (PSS-10)
时间窗: Baseline, 8, 12, and 24 weeks
Validated self-reporting instrument with 10 questions on perceived stress. Each question is rated on a 5-point Likert scale ranging from 0 = never to 4 = Very Often, referring to experiences in the past month. Total scores range from 0 to 40, higher = more stress.
Depressed mood - Patient Health Questionnaire-9, (PHQ-9)
时间窗: Baseline, 8, 12, and 24 weeks
A 9-item self-report measure of depressive symptoms. Each question is rated on a scale of 0 to 3, based on how often the symptom has been experienced in the past two weeks (0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day). The total score ranges from 0 to 27, higher scores indicating more severe depression.
Anxiety - Generalized Anxiety Disorder-7, (GAD-7)
时间窗: Baseline, 8, 12, and 24 weeks
A 7-item self-report questionnaire assessing symptoms of generalized anxiety disorder. Items are rated on a scale of 0-3 based on frequency over the past two weeks (0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day). The total score ranges from 0-21, with higher scores indicating more severe anxiety symptoms.
Pain - Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Pain Intensity
时间窗: Baseline, 8, 12, and 24 weeks
Patient-reported outcomes from the PROMIS system. Pain Interference items assess the extent to which pain hampers daily activities, social, and emotional functioning. Pain Intensity is assessed with a 0-10 numeric rating scale for worst, average, and current pain. Higher scores indicate greater pain burden.
次要结局
- Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)(Baseline, 8, 12, and 24 weeks)
- Acceptability quantitative - Satisfaction with interventions(12-weeks post interventions)
- Acceptability qualitative - Strengths and weaknesses of the interventions(12-weeks post intervention)
- Mental Well-being - Warwick-Edinburgh Mental Well-being Scale (WEMWBS)(Baseline, 8, 12, and 24 weeks)
- Insomnia - Insomnia Severity Index (ISI)(Baseline, 8, 12, and 24 weeks)
- Brief Resilience Scale (BRS)(Baseline, 8, 12, and 24 weeks)
- Leisure Time Exercise Questionnaire (LTEQ)(Baseline, 8, 12, and 24 weeks)
- Health Status and Medications(Baseline, 8, 12, and 24 weeks)
- Primary Care Probable Post-Traumatic Stress Disorder (PTSD) Screen for Diagnostic and Statistical Manual for Mental Disorders (DSM-5) (PC-PTSD-5)(Baseline, 8, 12, and 24 weeks)
研究者
E. Robert Schwartz
Professor and Chair Emeritus
University of Miami