Mindfulness-Based Group Visits for Menopause

MK
BA
Overseen ByBeth A Steinberg, PhD, RN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help women manage menopause symptoms through mindfulness and group support. Participants will attend eight monthly group sessions that combine health education, mindfulness exercises, and community discussions. The researchers aim to determine if these sessions, called "Navigating Menopause with a Mindfulness-Based Group Medical Visit," can reduce menopause symptoms, alleviate stress, and improve overall well-being. Women who have experienced irregular periods for at least three months and are dealing with menopause symptoms may be suitable for this trial. Sessions occur in person at The Ohio State University Center for Integrative Health. As an unphased trial, this study provides participants with the opportunity to explore innovative approaches to managing menopause symptoms in a supportive group setting.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, such as hormone therapy, hormonal contraceptives, hormone-altering medications, probiotics, and specific herbal supplements like Siberian rhubarb, Black cohosh, and Chaste tree berry, to participate in this trial.

What prior data suggests that this mindfulness-based group medical visit is safe for women experiencing menopause?

Research has shown that mindfulness-based activities are generally safe and manageable for most people. Studies have found that these practices can reduce anxiety, depression, and stress in women experiencing menopause, with no major side effects reported.

Mindfulness activities, such as those used in group medical visits, have improved symptoms and quality of life without medication. Participants often report better sleep, reduced stress, and improved mood. This suggests that this treatment is both effective and safe for most people.12345

Why are researchers excited about this trial?

Researchers are excited about the Mindfulness-Based Group Medical Visit for menopause because it offers a holistic approach that differs from traditional hormone replacement therapies and medications focused solely on symptom management. This treatment combines mindfulness practices, lifestyle education, and community support, providing a comprehensive way to address both physical and emotional well-being during menopause. By focusing on lifestyle changes and mental health, this approach aims to empower women with tools to manage their symptoms naturally, which is a shift from conventional treatments that often involve pharmaceuticals.

What evidence suggests that this mindfulness-based group visit is effective for menopause?

Research has shown that mindfulness activities can greatly help with menopause symptoms. Studies have found that these activities improve quality of life and reduce anxiety, stress, and depression in women experiencing menopause. One review found that mindfulness improved sleep and eased menopause symptoms overall. Another study showed that women who practiced mindfulness experienced fewer symptoms and better mental health. Overall, mindfulness appears to be a promising way to manage menopause symptoms. Participants in this trial will engage in a mindfulness-based group medical visit program designed to explore these benefits.13567

Are You a Good Fit for This Trial?

This trial is for women going through perimenopause or menopause who are interested in group-based, non-drug approaches to manage symptoms. Participants should be able to attend monthly group sessions and complete health assessments before, during, and after the program.

Inclusion Criteria

I am able to take part in the Mindfulness in Motion study activities.
WiFi connectivity or LTE to allow use of MyCap when not at OSU study site
I am between 40 and 60 years old.
See 4 more

Exclusion Criteria

I have gone through menopause due to surgery.
Inability to read and/or understand English (consent and questionnaires in English)
Current severe alcohol or substance abuse disorder
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend eight monthly group medical visits incorporating physical assessments, education on Lifestyle Medicine, mindfulness practices, and community discussions.

8 months
8 visits (in-person, monthly)

Follow-up

Participants are monitored for safety and effectiveness after the group medical visits, with assessments of stress, microbiome, and quality of life.

4 months

What Are the Treatments Tested in This Trial?

Interventions

  • Navigating Menopause with a Mindfulness-Based Group Medical Visit

Trial Overview

The study tests eight monthly group medical visits that combine lifestyle medicine education, mindfulness practices, physical check-ups, and supportive discussions led by trained professionals. The goal is to see if these sessions help with stress, symptoms, gut health, and quality of life.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Intervention GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials
891
Recruited
2,659,000+

Citations

A Pilot Study to Evaluate the Effects of Lifestyle Medicine ...

The purpose of this study is to assess the effectiveness of eight monthly group medical visits mindfulness practices, measures of your ...

Mindfulness-Based Stress Reduction (MBSR) or ... - PMC

This randomized controlled trial aimed to evaluate the effectiveness of Mindfulness-based Stress Reduction (MBSR) in reducing menopause-related symptoms.

The effectiveness of mindfulness-based interventions on ...

Systematic review indicates mindfulness-based interventions (MBIs) improve menopausal symptoms, mental health, and quality of life.

CBT and Mindfulness-Based Interventions for the ...

The meta-analysis revealed that both CBT and MBIs significantly improved anxiety and depressive symptoms in menopausal women.

Mindfulness-based Educational Intervention on Anxiety, ...

This study investigates the impact of a mindfulness-based educational intervention on anxiety, depression, stress, and quality of life in ...

The effects of mindfulness-based interventions on anxiety ...

This meta-analysis examines the effectiveness of MBIs in improving anxiety, depression, stress, and mindfulness scores in menopausal women.

The Impact of Mindfulness Practices on Menopausal ...

Together, these data suggest that integrating mindfulness‑based stress reduction or similar practices can be a safe, non‑pharmacologic ...