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Behavioral Intervention

SKY Breath Meditation for Mental Health

N/A

Waitlist Available

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how SKY Breath Meditation affects DNA, behavior, physiology, and more.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

SKY Breath Meditation is generally considered safe but may cause discomfort like lightheadedness or emotional distress during initial practices. Long-term side effects are not well documented but could include changes in mood or stress levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence rate

Heart rate variability

Recruitment rate

+3 more

Secondary study objectives

Brief-COPE

Epigenetic (DNA Methylation) changes

Gene expression changes

+6 more

Other study objectives

Assessment of changes in mitochondrial DNA damage-associated molecular patterns (mtDNA DAMPs) from blood serum.

Cytokine changes in serum samples

Serum biomarkers

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SKYExperimental Treatment1 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: ControlActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SKY

2016

N/A

~30

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