Women's Healthy Aging and Menopause; (WHAM)

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

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 Overview

• Status: Not yet recruiting
• Conditions: Health Education; Meditation
• Intervention / Treatment: Behavioral: Women's Health Education (WHE); Behavioral: Transcendental Meditation (TM)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Redwine, PhD; Phone Number: 305-243-5267; Email: lss61@miami.edu
• Study Contact Backup: Name: Jacqueline Allen-Magers, MS; Email: jacqueline.am@miu.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. ≥130 systolic blood pressure (SBP) ≤160 and/or 84 ≥ diastolic blood pressure (DBP) ≤100.
2. Perceived stress scale (PSS-4) > 5
3. Able to give informed consent.
4. Understand study procedures and comply with them for the length of the study.
5. Ages between 50 and 80 years.
6. Post-menopausal ≥ 1 year since last menstruation
7. Reads and speaks English
8. UHealth patients
9. Working at least part-time

Exclusion Criteria:

1. Currently in a meditation program.
2. Meditates more than once per week
3. Recent stroke or cerebral neurologic impairment.
4. Current uses of mood stabilizers or antipsychotics.
5. Has been diagnosed with bipolar disorder, schizophrenia, or substance use disorder.
6. Inability to give written informed consent in English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Transcendental Meditation (TM); 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).
Active Comparator: 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.	Behavioral: Women's Health Education (WHE); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 3 years
Recruitment feasibility-Reasons for not participating	A checklist completed by recruiters (schedule, time commitment, topic, ineligible, other)	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.	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)	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.	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.	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.	Baseline and 12 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.	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.	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.	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.	Baseline, 8, 12, and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability quantitative - Satisfaction with interventions	Satisfaction with interventions Likert Scale (0-4, with 0 as not at all satisfied and 4 as extremely satisfied).	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)	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.	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.	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.	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.	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.	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.	Baseline, 8, 12, and 24 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Edward R Schwartz, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Adherence Interventions; Medication Adherence; Health Education; Therapeutics; Mind-Body Therapies; Complementary Therapies; Spiritual Therapies; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Relaxation Therapy; Meditation
• Other Study ID Numbers: 20250622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No