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NCT Number: NCT07314827

Women's Healthy Aging and Menopause; (WHAM)

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.

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Key information

Age range

50 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥130 systolic blood pressure (SBP) ≤160 and/or 84 ≥ diastolic blood pressure (DBP) ≤100.
  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Transcendental Meditation (TM)

Behavioral

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).

Women's Health Education (WHE)

Behavioral

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.

Primary outcomes

  1. Recruitment feasibility-The number of individuals approached vs participate.

    Time frame: up to 3 years

    Recruiters will record the numbers of individuals who agree to participate vs interested in hearing about the study.

  2. Recruitment feasibility-Reasons for not participating

    Time frame: up to 3 years

    A checklist completed by recruiters (schedule, time commitment, topic, ineligible, other)

  3. Attendance feasibility - Training sessions attended by TM and WHE group

    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.

  4. Compliance feasibility - The number of meditation sessions per week for the TM participants.

    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)

  5. Stress - Perceived Stress Scale-10 (PSS-10)

    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.

  6. Depressed mood - Patient Health Questionnaire-9, (PHQ-9)

    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.

  7. Anxiety - Generalized Anxiety Disorder-7, (GAD-7)

    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.

  8. Pain - Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Pain Intensity

    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.

  9. Menopausal Symptoms - Greene Climacteric Scale (GCS)

    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.

  10. Fruits and Vegetables Intake

    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.

  11. 24-hour Hemodynamic Monitoring

    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.

Secondary outcomes

  1. Acceptability quantitative - Satisfaction with interventions

    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).

  2. Acceptability qualitative - Strengths and weaknesses of the interventions

    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)

  3. Mental Well-being - Warwick-Edinburgh Mental Well-being Scale (WEMWBS)

    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.

  4. Insomnia - Insomnia Severity Index (ISI)

    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.

  5. Primary Care Probable Post-Traumatic Stress Disorder (PTSD) Screen for Diagnostic and Statistical Manual for Mental Disorders (DSM-5) (PC-PTSD-5)

    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.

  6. Brief Resilience Scale (BRS)

    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.

  7. Leisure Time Exercise Questionnaire (LTEQ)

    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.

  8. Health Status and Medications

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jacqueline Allen-Magers, MS

CONTACT

[email protected]

Laura Redwine, PhD

CONTACT

[email protected]

305-243-5267

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

A Feasibility Study Examining the Comparison of Transcendental Meditation Versus Health Education on Psychological and Hemodynamic Function in Post-menopausal Women

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 2, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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