Clinical trial NCT03856892: Breath, Stress and Health: a Biocultural Study of Hatha Yoga Practice
Official title: Breath, Stress and Health: a Biocultural Study of Hatha Yoga Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Physiological
Stress, Psychological
Keywords: Yoga
Breath-based yoga
Stress management
Meditation
Hatha yoga
Anxiety mitigation
Mental health
Longevity
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to contribute uniquely to stress, longevity, and mental health research in two ways: by identifying clear protocols of breath-based yoga-meditative practice based on original materials; that are subsequently assessed with established scientific stress, biochemical immunity and longevity markers, and validated psychological measures that relate to mental health.

Detailed description: This study aims to contribute uniquely to stress, longevity, and mental health research in two ways: by identifying clear protocols of breath-based yoga-meditative practice based on original materials; that are subsequently assessed with established scientific stress markers across the sympathetic-adreno-medullar (SAM) axis, biochemical immunity and longevity markers, and validated psychological measures as related to mental health. The study couples emic perspectives from the traditional yoga knowledge base, both textual and practice, with empirical measures from science as an opportunity to bridge these worlds as a first known study of hatha yoga to be tackled by the means and methods of biocultural anthropology. It therefore highlights the importance of context and detail in terms of assessing human behavioral practices, where accuracy in terms of definitions, technique detail, and original purported intentions and outcomes are addressed as relevant when measuring and explaining empirical outcomes under modern research mixed methods.

Eligibility criteria: Inclusion Criteria:

* Novice to breath-based yoga practice
* Multicultural international participant base
* Fluent in English comprehension and reading
* In general good health
* Have a smartphone or similar device in order to receive surveys on a dedicated app

Exclusion Criteria:

* none

Primary outcomes:
measure: Change in Heart Rate Variability (HRV) Between Study Arms
timeFrame: Baseline, up to 6 months
Secondary outcomes:
measure: Change in Heart Rate Variability (HRV) Between High and Low Participation Level
timeFrame: Baseline, up to 6 months
measure: Change in Skin Conductance Level (SCL) Between Study Arms
timeFrame: Baseline, up to 6 months
measure: Change in Skin conductance level (SCL) Between High and Low Participation Level
timeFrame: Baseline, up to 6 months
measure: Change in Skin Conductance Response Between Study Arms
timeFrame: Baseline, up to 6 months
measure: Change in Skin Conductance Response Between High and Low Participation Level
timeFrame: Baseline, up to 6 months
measure: Change in Reactive Oxygen Species (ROS) Levels Between Study Arms
timeFrame: Baseline, up to 6 months
measure: Change in Reactive Oxygen Species (ROS) Between High and Low Participation Level
timeFrame: Baseline, up to 6 months
measure: Change in Total Antioxidant Status (TAS) Between Study Arms
timeFrame: Baseline, up to 6 months
measure: Change in Total Antioxidant Status (TAS) Between High and Low Participation Level
timeFrame: Baseline, up to 6 months
measure: Change in Levels of Antioxidant Enzyme Glutathione (GSH) Between Study Arms
timeFrame: Baseline, up to 6 months
measure: Change in levels of antioxidant enzyme Glutathione (GSH) Between High and Low Participation Level
timeFrame: Baseline, up to 6 months
measure: Change in Levels of Circulating IL-6 Between Study Arms
timeFrame: Baseline, up to 6 months
measure: Change in levels of circulating IL-6 Between High and Low Participation Level
timeFrame: Baseline, up to 6 months
measure: Change in Levels of Circulating Tumor-Necrosis Factor-alpha (TNF-α) Between Study Arms
timeFrame: Baseline, up to 6 months
measure: Change in levels of circulating TNF-α Between High and Low Participation Level
timeFrame: Baseline, up to 6 months
measure: Change in Upper Abdominal Muscle Tension Between Study Arms
timeFrame: Baseline, up to 6 months
measure: Change in Upper Abdominal Muscle Tension Between High and Low Participation Level
timeFrame: Baseline, up to 6 months
measure: Change in Self-assessment Questions Covering "how do you feel" score
timeFrame: Baseline, up to 6 months
measure: Change in Perceived Stress Reactivity Scale (PSRS) Score
timeFrame: Baseline, up to 6 months
measure: Change in Perceived Stress Scale (PSS) Score
timeFrame: Baseline, up to 6 months
measure: Change in Difficulties in Emotion Regulation Scale (DERS) Score
timeFrame: Baseline, up to 6 months
measure: Change in Depression Anxiety and Stress Scale (DASS) Score
timeFrame: Baseline, up to 6 months
measure: Change in Penn State Worry Questionnaire (PSWQ) Score
timeFrame: Baseline, up to 6 months
measure: Change in Positive and Negative Affect Scale (PANAS) Score
timeFrame: Baseline, up to 6 months
measure: Change in Beck Depression Inventory (BDI-II) Score
timeFrame: Baseline, up to 6 months
measure: Change in Beck Anxiety Inventory (BAI-II) Score
timeFrame: Baseline, up to 6 months
measure: Change in Profile of Mood States (POMS) Score
timeFrame: Baseline, up to 6 months
measure: Change in Coping Self-efficacy Scale (CSES) Score
timeFrame: Baseline, up to 6 months
measure: Changes in Multidimensional Assessment of Interoceptive Awareness (MAIA) 8-Subscale Scores
timeFrame: Baseline, up to 6 months
measure: Change in Mindful Attention Awareness Scale (MAAS) Score
timeFrame: Baseline, up to 6 months
measure: Change in Compassion Scale (CS) Score
timeFrame: Baseline, up to 6 months
measure: Change in Self-Compassion Scale - Short Form (SCS-SF) Score
timeFrame: Baseline, up to 6 months
measure: Change in Five Facet Mindfulness Questionnaire (FFMQ) Score
timeFrame: Baseline, up to 6 months
measure: Change in Heartland Forgiveness Scale Score
timeFrame: Baseline, up to 6 months
measure: Change in Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) Score
timeFrame: Baseline, up to 6 months
measure: Change in Gratitude Questionnaire - Six Item Form (GQ-6) Score
timeFrame: Baseline, up to 6 months
measure: Change in Spiritual Meaning Scale (SMS) Score
timeFrame: Baseline, up to 6 months
measure: Change in Telomere Length (TL)
timeFrame: Baseline, up to 6 months
Other outcomes:
measure: Change in Brain-derived Neurotrophic Factor (BDNF) Level in Blood Serum Between Study Arms
timeFrame: Baseline, up to 6 months
measure: Change in Growth Hormone Level in Blood Serum Between Study Arms
timeFrame: Baseline, up to 6 months
measure: Change in Oxytocin Level in Blood Serum Between Study Arms
timeFrame: Baseline, up to 6 months
measure: Change in Ghrelin Level in Blood Serum Between Study Arms
timeFrame: Baseline, up to 6 months
measure: Change in Leptin Level in Blood Serum Between Study Arms
timeFrame: Baseline, up to 6 months
Locations:
city: Lonavla
country: India
facility: Kaivalyadhama Yoga Institute
state: Maharashtra
Study officials:
affiliation: Emory University
name: Paul Dallaghan, PhD
role: PRINCIPAL_INVESTIGATOR
References: