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Not yet recruiting NCT07314827

Women's Healthy Aging and Menopause; (WHAM)

No phase Interventional Meditation Health Education

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcendental Meditation (TM), Women's Health Education (WHE).
Who it may be relevant to
Registry conditions: Meditation, Health Education. Basic parameters: 50 years — 80 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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
  • 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.

Primary outcome measures

  • Recruitment feasibility-The number of individuals approached vs participate. [Time frame: up to 3 years]
  • Recruitment feasibility-Reasons for not participating [Time frame: up to 3 years]
  • Attendance feasibility - Training sessions attended by TM and WHE group [Time frame: 12 weeks]
  • Compliance feasibility - The number of meditation sessions per week for the TM participants. [Time frame: 12 and 24 weeks]
  • Stress - Perceived Stress Scale-10 (PSS-10) [Time frame: Baseline, 8, 12, and 24 weeks]
  • Depressed mood - Patient Health Questionnaire-9, (PHQ-9) [Time frame: Baseline, 8, 12, and 24 weeks]
  • Anxiety - Generalized Anxiety Disorder-7, (GAD-7) [Time frame: Baseline, 8, 12, and 24 weeks]
  • Pain - Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Pain Intensity [Time frame: Baseline, 8, 12, and 24 weeks]
  • Menopausal Symptoms - Greene Climacteric Scale (GCS) [Time frame: Baseline, 8, 12, and 24 weeks]
  • Fruits and Vegetables Intake [Time frame: Baseline, 8, 12, and 24 weeks]
Secondary outcome measures (8)
  • Acceptability quantitative - Satisfaction with interventions [Time frame: 12-weeks post interventions]
  • Acceptability qualitative - Strengths and weaknesses of the interventions [Time frame: 12-weeks post intervention]
  • Mental Well-being - Warwick-Edinburgh Mental Well-being Scale (WEMWBS) [Time frame: Baseline, 8, 12, and 24 weeks]
  • Insomnia - Insomnia Severity Index (ISI) [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) [Time frame: Baseline, 8, 12, and 24 weeks]
  • Brief Resilience Scale (BRS) [Time frame: Baseline, 8, 12, and 24 weeks]
  • Leisure Time Exercise Questionnaire (LTEQ) [Time frame: Baseline, 8, 12, and 24 weeks]
  • Health Status and Medications [Time frame: Baseline, 8, 12, and 24 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT07314827 · 20250622

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗