Mindfulness for Stress Reduction

(BEING Mindful Trial)

Overseen By Sharon Ruyak, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of New Mexico

Disqualifiers: Major medical illness

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether mindfulness activities, such as meditation or yoga, can reduce stress and burnout among faculty and staff at the University of New Mexico's College of Nursing. Researchers seek to assess whether these activities improve feelings of belonging and physical health markers, like heart rate variability, which measures stress and relaxation. Participants will practice either meditation or yoga twice a week, complete surveys, and use a smart device to track changes. Ideal participants work at the College of Nursing, live in New Mexico, are generally in good health, and own a smartphone. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance well-being and workplace satisfaction.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on mindfulness practices like meditation and yoga, so it's unlikely that medication changes are required.

What prior data suggests that these mindfulness interventions are safe for stress reduction?

A previous study found that mindfulness meditation effectively lowers stress. Research has reviewed over 200 studies and shows that mindfulness-based therapy, including meditation, significantly reduces stress. This type of meditation is usually considered safe, with very few risks reported, though few studies have explored potential harmful effects.

For yoga, research suggests it is generally safe and well-tolerated. Yoga combines breathing, posture, and meditation, and is known for its benefits in reducing stress and improving mood and quality of life. Yoga instructors often offer modifications to make sessions accessible and reduce the risk of injury.

Both mindfulness meditation and yoga have strong evidence supporting their safety and effectiveness in reducing stress and enhancing well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using mindfulness meditation and yoga for stress reduction because these methods focus on holistic, non-pharmaceutical approaches to managing stress. Mindfulness meditation emphasizes developing awareness and equanimity through practices like zazen and kinhin, which help individuals cultivate a sustained mindfulness practice. Meanwhile, mindfulness yoga integrates breathwork, physical postures, and meditation to improve self-regulation and stress response. Unlike traditional stress-relief options like medication or therapy, these practices aim to unite mind, body, and spirit, offering a potentially safer and more natural way to enhance well-being and quality of life.

What evidence suggests that this trial's treatments could be effective for stress reduction?

Research has shown that mindfulness meditation, one of the treatments in this trial, can effectively reduce stress, anxiety, and depression, particularly in healthcare workers. A review of over 200 studies found that mindfulness-based therapies excel at lowering stress. Another study found that these practices can alter cortisol levels, a hormone related to stress, in healthy adults.

Similarly, yoga, another treatment option in this trial, improves mood, well-being, and stress management. It combines breathing exercises, physical poses, and meditation to connect the mind and body. Both mindfulness meditation and yoga, as studied in this trial, offer promising benefits for reducing stress and enhancing mental health. ^{1 3 6 7 8}

Who Is on the Research Team?

Sharon Ruyak

Principal Investigator

UNM HSC

Are You a Good Fit for This Trial?

This pilot study is for faculty and staff at the University of New Mexico College of Nursing who are over 18, in good health, employed by UNM CON, living in New Mexico, can attend six weeks of sessions, and have a smartphone. It excludes those with major medical conditions or any issues that prevent participation according to sports medicine guidelines.

Inclusion Criteria

Willing to complete research assessments

Own a smart phone

In general good health

Exclusion Criteria

I do not have a major illness that prevents me from joining the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants engage in mindfulness-based interventions (meditation or yoga) to improve psychosocial and physiological outcomes

6 weeks

Regular in-person sessions

Follow-up

Participants are monitored for changes in psychosocial and physiological outcomes post-intervention

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness Meditation
• Yoga

Trial Overview The trial tests if mindfulness-based interventions (MBI) like meditation or yoga can reduce stress and burnout while increasing belongingness among participants. It will measure feasibility through interviews and track changes in psychosocial factors like anxiety and physiological measures such as heart rate variability before and after the intervention.

How Is the Trial Designed?

Group I: Mindfulness Meditation Experimental Treatment 1 Intervention

Meditation is a practice of mental exercises designed to increase focus and cultivate a desire to relieve suffering in self and other. Many religious traditions have a form of meditation based practice. This study will focus on two forms of meditation both of which are focused on right mindfulness: 1) zazen which is a seated meditation primarily focused on the breath, posture, and sensation without attaching judgment. This is meant to develop awareness, equanimity, and insight, and 2) kinhin which is a walking meditation which is meant to connect mindfulness in one's movement by synchronizing breath and movement. It also focuses on development of awareness, equanimity, and insight. The two activities combined help the individual to nurture a thread of mindfulness. Instructors have developed a protocol to standardize the delivery of the meditation. Participants are requested to attend two meditation sessions per week.

Group II: Mindfulness Yoga Active Control 1 Intervention

Yoga is a holistic, multidimensional practice. There are three fundamental limbs of yoga: 1) breathwork (pranyanma), 2) physical postures with breathing techniques (asanas), and 3) meditation and visualization (Dhyana).) Yoga practice unites the mind, body and spirit leading to psychophysiological changes within the individual including improved self-regulation ability and stress response, mood, well-being, and quality of life. Yoga instructors will offer modifications and props such as blocks to ensure sessions are accessible to individuals of various abilities and minimize the risk of injury. Instructors have developed a detailed manual to standardize the delivery of the yoga intervention. Participants are requested to attend two yoga sessions per week.

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7511255/

The Effectiveness of Mindfulness-Based Stress Reduction ... The reviewed literature suggested that MBSR was effective in reducing HCPs experiences of anxiety, depression and stress.

2. apa.org apa.org/topics/mindfulness/meditation

Mindfulness meditation: A research-proven way to reduce ... Researchers reviewed more than 200 studies of mindfulness among healthy people and found mindfulness-based therapy was especially effective for reducing stress ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0306453023003931

Effectiveness of stress management interventions to ... Meta-analytic evidence suggests stress management interventions are effective in changing cortisol levels in healthy adults.

4. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/1809754

Meditation Programs for Psychological Stress and Well-being Among the 9 RCTs evaluating the effect on pain, we found moderate evidence that mindfulness-based stress reduction reduces pain severity to a small degree when ...

5. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2024.1347336/full

Exploring the sustained impact of the Mindfulness-Based ... Results: The findings revealed that the effectiveness of the MBSR program varied at different times and across different variables. Immediately ...

6. nccih.nih.gov nccih.nih.gov/health/meditation-and-mindfulness-effectiveness-and-safety

Meditation and Mindfulness: Effectiveness and Safety | NCCIH Meditation and mindfulness practices usually are considered to have few risks. However, few studies have examined these practices for potentially harmful ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2769761

Effect of a Brief Mindfulness-Based Program on Stress in ... This randomized clinical trial found that this brief mindfulness-based intervention was an effective and feasible means to reduce stress in health care ...

8. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2021.724126/full

Mindfulness Is Associated With Lower Stress and Higher ... Mindfulness was associated with lower perceived stress and higher work engagement in both cross-sectional and longitudinal analyses.