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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
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
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 moreSecondary study objectives
Brief-COPE
Epigenetic (DNA Methylation) changes
Gene expression changes
+6 moreOther study objectives
Assessment of changes in mitochondrial DNA damage-associated molecular patterns (mtDNA DAMPs) from blood serum.
Cytokine changes in serum samples
Serum biomarkers
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
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,621 Previous Clinical Trials
2,290,933 Total Patients Enrolled
M.D. Anderson Cancer CenterOTHER
3,039 Previous Clinical Trials
1,799,656 Total Patients Enrolled
Loma Linda UniversityOTHER
312 Previous Clinical Trials
260,860 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery in the last 3 months.I am currently taking lithium or medication that contains lithium.I have not been diagnosed with severe mental health conditions like depression, bipolar, or schizophrenia.I am over 21 and willing to follow the study's requirements.I am currently on hormone-replacement therapy.My BMI is over 35.I experience long-lasting confusion or have trouble breathing.I have a major medical condition like dementia, severe hypertension, or diabetes.I agree to complete all weekly follow-up sessions for SKY Breath practice.
Research Study Groups:
This trial has the following groups:- Group 1: SKY
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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