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| ID | Type | Description | Link |
|---|---|---|---|
| UAB | Other Grant/Funding Number | UAB |
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| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
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The goal of this pilot SKY (Sudarshan Kriya Yoga) Breath Meditation study is to establish feasibility and acceptability of the intervention; and investigate preliminary effectiveness of the intervention at the DNA methylation, RNA and protein levels in blood samples collected from participants before and after the 8 week SKY intervention. Primary outcomes also include preliminary effectiveness at the physiological level using a wearable device used for continuous monitoring. Secondary outcome measures include behavioral inventories.
The present study will recruit up to 60 participants in the SKY intervention and up to 60 participants in the control group. Recruitment is expected to take up to a year. After providing informed consent, participants will be randomly assigned to the SKY intervention group, or a waitlist control group. Interventions will be performed in-person in San Diego.
Prior to interventions, each participant will be asked to fill out behavioral questionnaires containing surveys and standardized cognitive measurements. Participants will be also asked to provide blood samples for biological assays (epigenetics, transcriptomics and proteomics). All participants will be scheduled for the questionnaire data collection and specimen collection up to two weeks preceding the start of either intervention. Participants will be asked to wear a Garmin vivoSmart5 smartwatch to collect physiological measures.
The SKY intervention will be administered in-person over three sessions over three consecutive days. All participants (SKY and control) will be asked to provide a second blood sample at the end of the third session of the SKY intervention. SKY participants will then engage in a remotely administered follow-up over up to eight weeks' time with the option to attend daily remotely-led breathwork sessions for 30 minutes. Participants will be asked to log daily practice engagement using online surveys through the eight-week follow-up period. Reminders will be provided to the participant intermittently during this time. During the period of eight weeks, the participants will return for 1-hour in-person follow-up SKY sessions once a week. They will be required to attend at least 75% of these weekly sessions. After 8 weeks of follow up, participants will provide a third sample of blood, and perform a post-intervention questionnaire.
Control participants will also have a similar schedule of data and biological sample collection as the SKY group. Waitlist controls will be provided the opportunity to attend the SKY retreat free of charge at the conclusion of the follow up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SKY | Experimental | 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. |
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| Control | No 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKY | Behavioral | The SKY intervention will be administered in-person over three sessions spread over three consecutive days by qualified instructors. Participants will then be followed up over eight weeks' time, where they will be given the option to attend daily 35 minute breathwork sessions, again, guided by experienced instructors. Participants will be required to log whether or not they practiced for each day in the eight-week period. They will also receive intermittent reminders about their daily practice during the 8-week follow-up period. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Descriptive statistics will be used to compute the proportion of screen-eligible participants enrolled by consent. Proportions will be computed, along with 95% confidence intervals, to indicate the precision of the point estimate. | Up to 1 year |
| Refusal rate | Descriptive statistics will be used to compute the proportion of screen-eligible individuals who refused to participate. Proportions will be computed, along with 95% confidence intervals, to indicate the precision of the point estimate. | Up to 1 year |
| Retention rate | Among the participants who originally attended the 3-day workshop, descriptive statistics will be used to compute proportion of participants that complete all 8 SKY follow-up study visits. Proportions will be computed, along with 95% confidence intervals, to indicate the precision of the point estimate. | Week to week during 8 weeks |
| Adherence rate | Descriptive statistics will be used to compute the frequency of home practice completion, weekly, by the intervention participants. Proportions will be computed, along with 95% confidence intervals, to indicate the precision of the point estimate. | 8 weeks during intervention period |
| Heart rate variability | Heart rate variability will be collected using the Garmin vivosmart5 watch | Continuous monitoring over 8-week intervention |
| Respiration rate | Respiration rate will be measured using the Garmin vivosmart5 watch |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress Scale | The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Lower values indicate less stress. | Pre/post 8-week intervention |
| Brief-COPE |
| Measure | Description | Time Frame |
|---|---|---|
| Cytokine changes in serum samples | Cytokine changes will be measured using ELISA assay on the blood sample collected and a standard ELISA panel for pro-inflammatory cytokines will be used to detect changes in their levels post intervention. | Pre/post 8-week intervention |
| Assessment of changes in mitochondrial DNA damage-associated molecular patterns (mtDNA DAMPs) from blood serum. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site: Confidential | San Diego | California | 92129 | United States |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001008 | Anxiety Disorders |
| D000092862 | Psychological Well-Being |
| D053120 | Respiratory Aspiration |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
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Participants are assigned to either the SKY arm or the control arm, that practices the HEP.
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Only the Principal investigator and study coordinator will have access to identifying information. They will de-identify the data and then send this de-identified data (sequencing data and the other clinical, demographic and behavioral data) into an easily accessible set of files for further analysis by the remaining team members. They will also make sure there are no medical record numbers, intervention type, or other identifying information in this dataset, and that the data is blinded in this respect. The files will be stored behind a secure firewall, so that it can only be accessed with permission by the members of the study group. The data will denote the SKY and control groups as Arm 1 & Arm 2 without indicating whether they refer to SKY or the control groups.
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| Continuous monitoring over 8-week intervention |
The Brief-COPE is a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. Higher scores indicate difficulty with coping. |
| Pre/post 8-week intervention |
| Pittsburgh Sleep Quality Assessment | The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. Higher scores indicate more sleep disturbances. | Pre/post 8-week intervention |
| Mini-Mood and Anxiety Symptom Questionnaire | The Mood and Anxiety Symptom Questionnaire (MASQ) is an instrument containing a range of symptoms relevant to depression and anxiety. Items are evaluated for Distress, Anxiety, Depression with higher scores on subcomponents indicate more extreme levels of each metric. | Pre/post 8-week intervention |
| SF-12v2 | The SF-12v2 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Higher scores indicate better physical and mental health. | Pre/post 8-week intervention |
| Social-Connectedness Scale | The social connectedness scale assesses the degree to which persons feel connected to others in their social environment. Higher scores indicate more social connectedness. The Social Connectedness Scale Revised [SCS-R; Cronbach's Alpha=0.94] will be used to measure social connectedness. | Pre/post 8-week intervention |
| Epigenetic (DNA Methylation) changes | DNA Methylation changes in SKY and control groups (pre vs post interventions) will be measured by EPIC v2 array and whole-genome bisulfite sequencing (WGBS). Data analyses will be performed utilizing previously published standard pipelines. | Pre/post 8 week intervention, and Day 3 (midpoint) |
| Gene expression changes | RNA level changes between SKY and control groups will be examined. | Pre/post 8 week intervention, and Day 3 (midpoint) |
| Proteomic changes | Protein level changes between SKY and control groups will be examined. | Pre/post 8 week intervention |
Cell-free DNA will be eluted to a specified serum volume and used for the mtDNA DAMPs assays. |
| Pre/post 8-week intervention |
| Serum biomarkers | Serum samples will be collected using standard procedures from the blood samples and immunoassayed using enzyme-linked immunosorbent assay to detect serum biomarkers | Pre/post 8-week intervention |
| D012120 |
| Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |