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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
60
Orientation: 18-minute self-guided video; 30-45 minute remote group introductory talk. Instructional phase: 10-minute individual interview (phone/Zoom); one 60-75 minute in-person 1:1 TM instruction session at Miami TM Center, Lennar Center, or University of Miami (UM) Osher Center; three consecutive in-person group sessions (60-75 minutes each). Follow-up seminars: Six sessions over nine weeks (in person or Zoom), including a "10th Day Check" and additional \~30-minute seminars at 1, 2, and 3 months. Home practice: Two daily TM sessions (20 minutes each, morning and evening).
Stage 1: 30-minute video and introductory lecture on menopause and cardiovascular health. Stage 2: 60-minute one-on-one health coach meeting plus nutrition video. Stage 3: Eight sessions (\~30 minutes each) with health check-ins, materials, and videos covering physical activity for heart and bone health, sleep and stress management during menopause, and lifestyle goal review and planning.
University of Miami
Miami, Florida, United States
Recruitment feasibility-The number of individuals approached vs participate.
Recruiters will record the numbers of individuals who agree to participate vs interested in hearing about the study.
Time frame: up to 3 years
Recruitment feasibility-Reasons for not participating
A checklist completed by recruiters (schedule, time commitment, topic, ineligible, other)
Time frame: up to 3 years
Attendance feasibility - Training sessions attended by TM and WHE group
Training sessions attended by the TM participants as well as the attendance and participation in videos watched for the WHE group will be recorded.
Time frame: 12 weeks
Compliance feasibility - The number of meditation sessions per week for the TM participants.
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)
Time frame: 12 and 24 weeks
Stress - Perceived Stress Scale-10 (PSS-10)
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.
Time frame: Baseline, 8, 12, and 24 weeks
Depressed mood - Patient Health Questionnaire-9, (PHQ-9)
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.
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Time frame: Baseline, 8, 12, and 24 weeks
Anxiety - Generalized Anxiety Disorder-7, (GAD-7)
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.
Time frame: Baseline, 8, 12, and 24 weeks
Pain - Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Pain Intensity
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.
Time frame: Baseline, 8, 12, and 24 weeks
Menopausal Symptoms - Greene Climacteric Scale (GCS)
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.
Time frame: Baseline, 8, 12, and 24 weeks
Fruits and Vegetables Intake
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.
Time frame: Baseline, 8, 12, and 24 weeks
24-hour Hemodynamic Monitoring
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.
Time frame: Baseline and 12 weeks
Acceptability quantitative - Satisfaction with interventions
Satisfaction with interventions Likert Scale (0-4, with 0 as not at all satisfied and 4 as extremely satisfied).
Time frame: 12-weeks post interventions
Acceptability qualitative - Strengths and weaknesses of the interventions
Participants will be asked to write one to two sentences on the strengths and one to two sentences on the weaknesses of the intervention e.g., time commitment, travel to sites (TM group)
Time frame: 12-weeks post intervention
Mental Well-being - Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
A 14-item self-report scale assessing positive mental health and well-being. Each item is rated on a 5-point Likert scale from 1 = None of the time to 5 = All of the time, based on experiences over the past two weeks. Total scores range from 14-70, with higher scores reflecting greater well-being.
Time frame: Baseline, 8, 12, and 24 weeks
Insomnia - Insomnia Severity Index (ISI)
A 7-item self-report measure assessing the nature, severity, and impact of insomnia. Each item is scored on a 0-4 scale (0 = No problem, 4 = Very severe problem) based on the previous two weeks. Total scores range from 0-28, with higher scores indicating more severe insomnia symptoms.
Time frame: 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)
A 5-item self-report screening tool for post-traumatic stress disorder. Respondents indicate whether they have been bothered by PTSD symptoms in the past month with a yes/no format. A cutoff of 3 or more positive responses suggests probable PTSD.
Time frame: Baseline, 8, 12, and 24 weeks
Brief Resilience Scale (BRS)
A 6-item self-report questionnaire assessing the ability to bounce back or recover from stress. Each item is rated on a 5-point scale from 1 = Strongly disagree to 5 = Strongly agree. Scores are averaged, with higher scores reflecting greater resilience.
Time frame: Baseline, 8, 12, and 24 weeks
Leisure Time Exercise Questionnaire (LTEQ)
A self-report questionnaire measuring the frequency of mild, moderate, and strenuous exercise during free time in a typical week. Frequencies are weighted by estimated metabolic equivalents (METs) and summed to yield a total exercise score.
Time frame: Baseline, 8, 12, and 24 weeks
Health Status and Medications
Participants self-report current health status and provide details on prescribed medications, including type, dosage, and frequency. This measure tracks changes in medication use over time.
Time frame: Baseline, 8, 12, and 24 weeks