MeditationNCT07314827
Women's Healthy Aging and Menopause; (WHAM)
A study testing Transcendental Meditation (TM) and Women's Health Education (WHE) in people with Meditation and Health Education, run by University of Miami at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Meditation, Health Education
- What is being tested?
- Transcendental Meditation (TM) and Women's Health Education (WHE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥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
Show all 9Show fewer
- Reads and speaks English
- UHealth patients
- Working at least part-time
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jacqueline Allen-Magers, MS contact
About this study
Official title: 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.
- Conditions
- Meditation, Health Education
- Being tested
- Transcendental Meditation (TM), Women's Health Education (WHE)
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcendental Meditation (TM)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Transcendental Meditation (TM) | Experimental | 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. Receives: Behavioral: Transcendental Meditation (TM) |
| Women's Health Education (WHE) | Active comparator | 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. Receives: Behavioral: Women's Health Education (WHE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 years
Recruitment feasibility-Reasons for not participating
A checklist completed by recruiters (schedule, time commitment, topic, ineligible, other)
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 weeks
Secondary outcomes (8)
Acceptability quantitative - Satisfaction with interventions
Satisfaction with interventions Likert Scale (0-4, with 0 as not at all satisfied and 4 as extremely satisfied).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 8, 12, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeditationStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E. Robert Schwartz, University of Miami
- Investigators
- Edward R Schwartz, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314827
- Sponsor's protocol ID
- 20250622
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Examining the Comparison of Transcendental Meditation Versus Health Education on Psychological and Hemodynamic Function in Post-menopausal Women
- ClinicalTrials.gov ID
- NCT07314827
- Acronym / sponsor ID
- 20250622
- Conditions
- Meditation, Health Education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcendental Meditation (TM) | Experimental | Behavioral: 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. |
| Women's Health Education (WHE) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Transcendental Meditation (TM) |
| 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. | Behavioural | Women's Health Education (WHE) |
Primary outcome
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.
Recruitment feasibility-Reasons for not participating
Time frame: up to 3 years
A checklist completed by recruiters (schedule, time commitment, topic, ineligible, other)
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.
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)
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.
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.
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.
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.
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.
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.
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacqueline Allen-Magers, MS contact
Edward R Schwartz, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcendental Meditation (TM) and Women's Health Education (WHE) in people with Meditation and Health Education, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Redwine, PhD (305-243-5267, lss61@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment feasibility-The number of individuals approached vs participate. (time frame: up to 3 years). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.