University of Miami
Miami, Florida, 33136, United States
NCT Number: NCT07314827
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.
Trial opening soon.
Get Notified50 year–80 year
Female
Interventional
Not applicable
Miami, Florida, 33136, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: up to 3 years
Recruiters will record the numbers of individuals who agree to participate vs interested in hearing about the study.
Time frame: up to 3 years
A checklist completed by recruiters (schedule, time commitment, topic, ineligible, other)
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12-weeks post 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 intervention
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: Baseline, 8, 12, and 24 weeks
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
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
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
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
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
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.
Contact information is provided by the study sponsor or research team.
Jacqueline Allen-Magers, MS
CONTACT
Laura Redwine, PhD
CONTACT
University of Miami
Other
A Feasibility Study Examining the Comparison of Transcendental Meditation Versus Health Education on Psychological and Hemodynamic Function in Post-menopausal Women
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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