SKY Breath Meditation for Mental Health

Recruiting at 1 trial location

Overseen By Ritu Aneja, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Lithium

Disqualifiers: Dementia, Hypertension, Cancer, others

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

Compensation: Varies

Number of Visits: 13

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests SKY Breath Meditation to determine its effectiveness in improving mental health by reducing stress through breathing techniques, yoga, and emotional resilience training. Researchers aim to evaluate the meditation's effectiveness by analyzing changes in blood samples and using wearable devices to monitor participants. Healthy individuals over 21, without conditions like asthma or depression, and who do not regularly meditate, may be ideal candidates. Participants will attend in-person sessions and continue practicing at home for eight weeks. A control group will be observed without intervention but can try the meditation for free afterward. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on mental health and stress reduction.

What prior data suggests that the SKY Breath Meditation is safe for mental health?

Research has shown that SKY Breath Meditation is generally safe and well-tolerated. One study with 129 doctors found that SKY significantly reduced stress, anxiety, and depression, with no major side effects reported. The study also noted improvements in mental health and mindfulness.

SKY Breath Meditation employs specific breathing techniques and meditation to manage stress. As a non-invasive practice, it is considered very safe.

Overall, evidence suggests that SKY Breath Meditation is safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SKY Breath Meditation for mental health because it offers a unique approach compared to traditional treatments like medication or talk therapy. Unlike these standard methods, SKY Breath Meditation focuses on a combination of breathwork, emotional resilience training, yoga, and leadership skills to tackle stress and mental health issues. Its distinctive breathing techniques are designed to rapidly reduce stress responses and correct autonomic imbalances, which is a novel mechanism of action. This holistic approach not only targets mental well-being but also empowers participants with skills for personal growth and resilience, potentially offering quicker and more sustainable results.

What evidence suggests that SKY Breath Meditation is effective for mental health?

Studies have shown that SKY Breath Meditation, which participants in this trial may receive, can greatly reduce stress, anxiety, and depression. In a trial with 129 doctors, those who practiced SKY reported significant improvements in their mental health. SKY employs specific breathing techniques to manage the body's stress response. Research shows that these techniques can enhance emotional strength and overall well-being. Evidence suggests that SKY could effectively improve mental health by lowering stress and anxiety levels. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy adults over 21 who can understand English at a 5th-grade level and commit to follow-up sessions of SKY Breath Meditation. It's not for those underweight or obese, recent surgery patients, pregnant women, heavy drinkers, smokers, regular meditators, or with certain medical/psychiatric conditions.

Inclusion Criteria

Minimum 5th grade equivalent competency in English

I am over 21 and willing to follow the study's requirements.

I agree to complete all weekly follow-up sessions for SKY Breath practice.

Exclusion Criteria

Heavy alcohol drinker (per CDC definition, 8 or more drinks per week for women, 15 or more drinks per week for men)

I have not had major surgery in the last 3 months.

I am currently taking lithium or medication that contains lithium.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 1 year

Pre-Intervention Assessment

Participants complete behavioral questionnaires and provide blood samples for biological assays

Up to 2 weeks

1 visit (in-person)

SKY Intervention

Participants attend in-person SKY sessions over three consecutive days, including breathwork, emotional resilience training, yoga, and leadership skills

3 days

3 visits (in-person)

Follow-up

Participants engage in daily remote SKY sessions and weekly in-person reinforcement sessions, with continuous physiological monitoring and logging of practice engagement

8 weeks

8 visits (in-person), daily remote sessions

Post-Intervention Assessment

Participants provide a third blood sample and complete a post-intervention questionnaire

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Health Enhancement Program
• SKY Breath Meditation

Trial Overview The study tests how SKY Breath Meditation affects DNA methylation in blood samples before and after the practice. It also looks at changes in behavior, gene expression patterns (transcriptomics), protein levels (proteomics), and physiological responses.

How Is the Trial Designed?

Group I: SKY Experimental Treatment 1 Intervention

In-person SKY sessions will be 3 hours long on each of 3 consecutive days, and participants must be willing to attend all 3 sessions. Each session comprises a combination of breathwork, emotional resilience training, yoga, and leadership skills. The SKY technique includes a unique set of standardized breathing techniques to rapidly reduce neuroendocrine stress responses and the autonomic imbalance due to sympathetic overdrive. 8 weeks of online and/or in-person sessions will be delivered to participants in the follow-up period after the initial in-person intervention. They will receive intermittent reminders about their daily practice during the 8-week follow-up period. The participants will be asked to engage in daily 30 minute SKY sessions remotely, that is led by an instructor. Each participant will be required to log in the number of times a week they practice. In addition, weekly 60-minute reinforcement sessions will be conducted, in-person.

Group II: Control Active Control 1 Intervention

Waitlist control participants will not be provided any intervention. However, they will have the same schedule for data and biological specimen collection as the SKY intervention participants. They will be provided an opportunity to take the SKY retreat free of charge at the end of the follow up period.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

Loma Linda University

Collaborator

Trials

322

Recruited

267,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07220421

Foundational Programs to Combat Clinician Stress The SKY Breathing and Sahaj Meditation program involves teaching cyclical breathing techniques with various hand positions and a Guided ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2814344

Sudarshan Kriya Yoga Breathing and a Meditation ... This randomized clinical trial of 129 practicing physicians found that SKY significantly reduced stress, anxiety, and depression on the 42-Item Depression, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10831575/

Sudarshan Kriya Yoga Breathing and a Meditation ... This randomized clinical trial of 129 practicing physicians found that SKY significantly reduced stress, anxiety, and depression.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05523414

The Effect of SKY Breath Meditation on Health and Well ... Primary outcomes also include preliminary effectiveness at the physiological level using a wearable device used for continuous monitoring. Secondary outcome ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12453132/

A Comprehensive Yogic Breathing Program: Evidence for Use ... This review aims to compile evidence for the use of SKY in medicine and also explore the mechanism through which it acts based on published ...

6. trialx.com trialx.com/clinical-trials/listings/238050/the-effect-of-sky-breath-meditation-on-health-and-well-being/

The Effect of SKY Breath Meditation on Health and Well- ... Primary outcomes also include preliminary effectiveness at the physiological level using a wearable device used for continuous monitoring.

7. medrxiv.org medrxiv.org/content/10.1101/2025.01.04.25319992v1.full-text

Effects of Sudarshan Kriya Yoga (SKY) Breath Meditation ... A 2020 study showed that the SKY breath meditation improved depression, stress, mental health, mindfulness, positive affect, and social ...