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Stress, PhysiologicalYogaNCT03856892

Breath, Stress and Health: a Biocultural Study of Hatha Yoga Practice

A study testing High Dose Yoga and Medium Dose Yoga in people with Stress, Physiological and Stress, Psychological, run by Emory University at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Stress, Physiological, Stress, Psychological
What is being tested?
High Dose Yoga and Medium Dose Yoga
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
1 siteIndia
Study dates
11 Jan 2019to 17 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country.

India1 site
  • Kaivalyadhama Yoga Institute

    Lonavla, Maharashtra, 410403

Other trials in India

About this study

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.

Read the 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.

Being tested
High Dose Yoga, Medium Dose Yoga
Keywords
Yoga, Breath-based yoga, Stress management, Meditation, Hatha yoga, Anxiety mitigation, Mental health, Longevity
Medical subject headings
Stress, Psychological, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Dose YogaOther

    Participants engage in an intensive full yoga practice of hatha breath-based practices and inner meditative techniques along with body-based asana. Intensive level uses breath, management of abdomen, inner focus in all practices. The "high dose" of yoga is an interpretation of the Translational Model of Yoga (TMY) and Yoga Process formula, both developed in this study's cultural research: a systematized psycho-physical yoga method of Hatha Zone (HZ) focus (below-navel, exhale, inner focus), incorporating key components of practice-focus-surrender (PFS) approach and repeat-engage-trust (RET) elements.

  • Medium Dose YogaOther

    The "medium dose" of yoga is a regular practice of primarily body-posture training with minimal reference to the breath, but with a longer period of time duration in training prior to intervention commencement. Participants have 5 months of pre-training before initiating the intervention.

Study groups in NCT03856892
Study groupRoleWhat they receive
Active Study GroupExperimentalParticipants randomized to the Active Study Group are asked to follow a daily routine of the three protocols of psycho-physical yoga component techniques: Slow Engaged Dynamic Asana (SEDA), Breath Regulated Engaged Meditation (BREM), Sound Heart Engaged Meditation (SHEM). This intervention involves more hours in daily practice to equate to a "high dose" of breath and meditative techniques.
Receives: Other: High Dose Yoga
Active ControlActive comparatorParticipants randomized to the Active Control study arm are asked to follow a daily routine of low-to mid-intensity body posture practice that is body-based and has minimal breath or meditative elements. This intervention involves fewer hours in daily practice to equate to a "medium dose" of body focused techniques
Receives: Other: Medium Dose Yoga
Passive ControlNo interventionParticipants randomized to the Passive Control study arm do not receive a study intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Heart Rate Variability (HRV) Between Study Arms

    Heart rate variability (HRV) is measured by electrocardiogram.

    Measured: Baseline, up to 6 months

Secondary outcomes (38)
  1. Change in Heart Rate Variability (HRV) Between High and Low Participation Level

    Heart rate variability (HRV) is measured by electrocardiogram. Participants will be categorized as higher teacher-rated "engaged participation" or lower teacher-rated "engaged participation" and these groups will be compared.

    Measured: Baseline, up to 6 months

  2. Change in Skin Conductance Level (SCL) Between Study Arms

    Skin conductance level (SCL) is measured by electrodermal activity (EDA).

    Measured: Baseline, up to 6 months

  3. Change in Skin conductance level (SCL) Between High and Low Participation Level

    Skin conductance level (SCL) is measured by electrodermal activity (EDA). Participants will be categorized as higher teacher-rated "engaged participation" or lower teacher-rated "engaged participation" and these groups will be compared.

    Measured: Baseline, up to 6 months

  4. Change in Skin Conductance Response Between Study Arms

    Skin conductance response is measured by electrodermal activity (EDA).

    Measured: Baseline, up to 6 months

  5. Change in Skin Conductance Response Between High and Low Participation Level

    Skin conductance response is measured by electrodermal activity (EDA). Participants will be categorized as higher teacher-rated "engaged participation" or lower teacher-rated "engaged participation" and these groups will be compared.

    Measured: Baseline, up to 6 months

  6. Change in Reactive Oxygen Species (ROS) Levels Between Study Arms

    Oxidative stress will be measured by ROS levels.

    Measured: Baseline, up to 6 months

  7. Change in Reactive Oxygen Species (ROS) Between High and Low Participation Level

    Oxidative stress will be measured by ROS levels. Participants will be categorized as higher teacher-rated "engaged participation" or lower teacher-rated "engaged participation" and these groups will be compared.

    Measured: Baseline, up to 6 months

  8. Change in Total Antioxidant Status (TAS) Between Study Arms

    Change in TAS will be measured by blood sample analysis.

    Measured: Baseline, up to 6 months

  9. Change in Total Antioxidant Status (TAS) Between High and Low Participation Level

    Change in TAS will be measured by blood sample analysis. Participants will be categorized as higher teacher-rated "engaged participation" or lower teacher-rated "engaged participation" and these groups will be compared.

    Measured: Baseline, up to 6 months

  10. Change in Levels of Antioxidant Enzyme Glutathione (GSH) Between Study Arms

    Glutathione (GSH) is an antioxidant capable of preventing damage to important cellular components caused by reactive oxygen species such as free radicals, peroxides, lipid peroxides, and heavy metals. Change in levels of GSH will be measured by blood sample analysis.

    Measured: Baseline, up to 6 months

  11. Change in levels of antioxidant enzyme Glutathione (GSH) Between High and Low Participation Level

    Glutathione (GSH) is an antioxidant capable of preventing damage to important cellular components caused by reactive oxygen species such as free radicals, peroxides, lipid peroxides, and heavy metals. Change in levels of GSH will be measured by blood sample analysis. Participants will be categorized as higher teacher-rated "engaged participation" or lower teacher-rated "engaged participation" and these groups will be compared.

    Measured: Baseline, up to 6 months

  12. Change in Levels of Circulating IL-6 Between Study Arms

    Interleukin 6 (IL-6) is an interleukin that acts as both a pro-inflammatory cytokine and an anti-inflammatory myokine. Levels of circulating IL-6 will be assessed by blood sample analysis.

    Measured: Baseline, up to 6 months

  13. Change in levels of circulating IL-6 Between High and Low Participation Level

    Interleukin 6 (IL-6) is an interleukin that acts as both a pro-inflammatory cytokine and an anti-inflammatory myokine. Levels of circulating IL-6 will be assessed by blood sample analysis. Participants will be categorized as higher teacher-rated "engaged participation" or lower teacher-rated "engaged participation" and these groups will be compared.

    Measured: Baseline, up to 6 months

  14. Change in Levels of Circulating Tumor-Necrosis Factor-alpha (TNF-α) Between Study Arms

    Tumor necrosis factor is a cell signaling protein (cytokine) involved in systemic inflammation. Change in levels of circulating TNF-α will be assessed by blood sample analysis.

    Measured: Baseline, up to 6 months

  15. Change in levels of circulating TNF-α Between High and Low Participation Level

    Tumor necrosis factor is a cell signaling protein (cytokine) involved in systemic inflammation. Change in levels of Circulating TNF-α will be assessed by blood sample analysis. Participants will be categorized as higher teacher-rated "engaged participation" or lower teacher-rated "engaged participation" and these groups will be compared.

    Measured: Baseline, up to 6 months

  16. Change in Upper Abdominal Muscle Tension Between Study Arms

    Upper abdominal muscular tension levels is assessed as Muscle Tone and Muscle Stiffness, and is measured by the MyotonPlus digital palpation device at a precise site on the upper region of the Rectus Abdominis (RA) muscle.

    Measured: Baseline, up to 6 months

  17. Change in Upper Abdominal Muscle Tension Between High and Low Participation Level

    Upper abdominal muscular tension levels is assessed as Muscle Tone and Muscle Stiffness, and is measured by the MyotonPlus digital palpation device at a precise site on the upper region of the Rectus Abdominis (RA) muscle.

    Measured: Baseline, up to 6 months

  18. Change in Self-assessment Questions Covering "how do you feel" score

    Self-assessment questions covering "how do you feel", with ongoing 3 daily-based questions once a week.

    Measured: Baseline, up to 6 months

  19. Change in Perceived Stress Reactivity Scale (PSRS) Score

    The Perceived Stress Reactivity Scale (PSRS), a 23-item questionnaire with 5 subscales (Prolonged Reactivity, Reactivity to Failure, Reactivity to Social Conflicts, Reactivity to Work Overload, and Reactivity to Social Evaluation) and 1 overall scale. The PSRS overall score ranges from 0 to 30 and higher scores are associated with increased symptoms of depression and sleep disturbances.

    Measured: Baseline, up to 6 months

  20. Change in Perceived Stress Scale (PSS) Score

    The Perceived Stress Scale (PSS) is a 10-item instrument assessing feelings and thoughts related to stress during the past month. Each item is rated on a 5-point scale ranging from never (0) to very often (4). Total scores range from 0 to 40 with higher scores indicating higher perceived stress.

    Measured: Baseline, up to 6 months

  21. Change in Difficulties in Emotion Regulation Scale (DERS) Score

    The Difficulties in Emotion Regulation Scale (DERS) is a 36-item instrument assessing emotion dysregulation and includes six subscales (non-acceptance of emotions, difficulty with goal-directed behavior in the presence of negative emotions, difficulty controlling impulses in the presence of negative emotions, lack of awareness of emotions, limited use of effective emotion regulation strategies, and lack of understanding of emotions). Responses are scaled from 1 (almost never) to 5 (almost always). Total raw scores range from 36 to 180; certain items are reverse scored so that higher scores indicate increased difficulty with emotion regulation.

    Measured: Baseline, up to 6 months

  22. Change in Depression Anxiety and Stress Scale (DASS) Score

    The DASS is a 42-item self-administered questionnaire designed to measure the magnitude of three negative emotional states: depression, anxiety, and stress. The DASS-Depression focuses on reports of low mood, motivation, and self-esteem, DASS-anxiety on physiological arousal, perceived panic, and fear, and DASS-stress on tension and irritability. Individual patient scores on the DASS subscales can be interpreted by converting them to z-scores and comparing to the normative values contained within the DASS manual. A z-score < 0.5 is considered to be within the normal range, a z-score of 0.5 to 1.0 is mild, 1.0 to 2.0 is moderate, 2.0 to 3.0 is considered severe, and z-scores > 3 are considered to be extremely severe depression/anxiety/stress.

    Measured: Baseline, up to 6 months

  23. Change in Penn State Worry Questionnaire (PSWQ) Score

    The Penn State Worry Questionnaire (PSWQ) is a self-administered, 16-item, Likert-type scale designed to measure the trait of worry. Responses to items are rated from 1 to 5 where less worry = 1 and a lot of worry = 5. Total scores range from 16 to 80 and higher scores indicate greater severity of the trait of worry.

    Measured: Baseline, up to 6 months

  24. Change in Positive and Negative Affect Scale (PANAS) Score

    The Positive and Negative Affect Scale (PANAS) consists of 10 positively and 10 negatively valanced word items. Items are rated by the participant for the extent they are feeling this "right now" on a scale of 1- slightly or not at all through 5- extremely. Total scores can range from 10 to 50, with higher scores representing higher levels of positive effect and lower scores having negative effect.

    Measured: Baseline, up to 6 months

  25. Change in Beck Depression Inventory (BDI-II) Score

    The BDI-II is a self-report 21-item scale used to assess the current severity of depression. Each item is rated on a four-point scale (0 to 3) with possible total scores ranging from 0 to 63. Scores provide a measure of the severity of self-reported depression: 0 -9 minimal, 10 -16 mild, 17-29 moderate, and 30 - 63 severe.

    Measured: Baseline, up to 6 months

  26. Change in Beck Anxiety Inventory (BAI-II) Score

    The BAI-II is a 21-item self-report measure of anxiety symptoms, rated on a 4-point Likert scale. Items are rated from 0 = not at all to 3 = severely. Total scores range from 0 to 63 and higher scores indicate greater anxiety.

    Measured: Baseline, up to 6 months

  27. Change in Profile of Mood States (POMS) Score

    The Profile of Mood States (POMS) scale is a 30-item psychological rating scale used to assess transient, distinct mood states. Participants rate the extent to which they feel unhappy, blue, lonely, gloomy, and worthless on a scale from 0 (not at all) to 4 (extremely). Scores range from 0 to 120 with higher scores reflecting a more negative mood state.

    Measured: Baseline, up to 6 months

  28. Change in Coping Self-efficacy Scale (CSES) Score

    The CSES is a 26-item scale that measures one's perceived ability to cope with life's difficulties. Responses are given on a scale from 0 to 10 where 0 = cannot do at all and 10 = certain can do. Total scores range from 0 to 260 where higher scores indicate greater self-efficacy with coping skills.

    Measured: Baseline, up to 6 months

  29. Changes in Multidimensional Assessment of Interoceptive Awareness (MAIA) 8-Subscale Scores

    The Multidimensional Assessment of Interoceptive Awareness (MAIA) assesses various aspects of interoception with 8 subscales of: Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, and Trusting. The subscales include 3 to 7 items and scored by taking the average of the item responses. Responses are given on a 6-point scale where "never" = 0 and "always" = 5. Total scores for each subscale range from 0 to 5 and higher scores indicate greater levels of interoceptive awareness.

    Measured: Baseline, up to 6 months

  30. Change in Mindful Attention Awareness Scale (MAAS) Score

    The Mindful Attention Awareness Scale (MAAS) is a 15-item instrument assessing mindfulness (attention to what is occurring in the present). Responses are given on a 6-point scale where "almost always" = 1 and "almost never" = 6. The total score is the average of responses to the 15 items and ranges from 1 to 6 where higher scores indicate greater mindfulness to the present moment.

    Measured: Baseline, up to 6 months

  31. Change in Compassion Scale (CS) Score

    The Compassion Scale (CS) is a 16-item instrument assessing compassion for others. Responses are given on a 5-point scale where "almost never" = 1 and "almost always" = 5. The total score is the average of responses to the 16 items and ranges from 1 to 5 where higher scores indicate greater compassion towards others.

    Measured: Baseline, up to 6 months

  32. Change in Self-Compassion Scale - Short Form (SCS-SF) Score

    The Self-Compassion Scale - Short Form (SCS-SF) is a 12-item instrument assessing self-compassion. Responses are given on a 5-point scale where "almost never" = 1 and "almost always" = 5. The total score is the average of responses to the 12 items and ranges from 1 to 5 where higher scores indicate greater self-compassion.

    Measured: Baseline, up to 6 months

  33. Change in Five Facet Mindfulness Questionnaire (FFMQ) Score

    The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item instrument with five subscales of: Observing, Describing, Acting with Awareness, Nonjudging, and Nonreactivity. Responses are given on a 5-point scale where "never or very rarely true" = 1 and "very often or always true" = 5. Scores can be obtained for each subscale and for a total score by averaging item responses. Total scores range from 1 to 5 where higher scores indicate greater mindfulness.

    Measured: Baseline, up to 6 months

  34. Change in Heartland Forgiveness Scale Score

    The Heartland Forgiveness Scale is an 18-item instrument assessing dispositional forgiveness, with 3 subscales of: Forgiveness of Self, Forgiveness of Others, and Forgiveness of Situations. Responses are given on a 7-point scale where "almost always false of me" = 1 and "almost always true of me" = 7. Total scores for each subscale range from 6 to 42, and the overall total score ranges from 18 to 126. Higher scores indicate greater dispositional forgiveness.

    Measured: Baseline, up to 6 months

  35. Change in Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) Score

    The Cognitive and Affective Mindfulness Scale- Revised (CAMS-R) instrument assessing mindfulness with 12 items. Responses are given on a 4-point scale where "rarely/not at all" = 1 and "almost always" = 5. The total score ranges from 12 to 48 and higher scores indicate greater mindfulness.

    Measured: Baseline, up to 6 months

  36. Change in Gratitude Questionnaire - Six Item Form (GQ-6) Score

    The Gratitude Questionnaire - Six Item Form (GQ-6) instrument measures the experience of gratitude in daily life with 6 items. Responses are given on a 7-point scale where "strongly disagree" = 1 and "strongly agree" = 7. The total score is the average of responses to the 6 items and ranges from 1 to 7 where higher scores indicate greater gratitude.

    Measured: Baseline, up to 6 months

  37. Change in Spiritual Meaning Scale (SMS) Score

    The Spiritual Meaning Scale (SMS) measures an individuals belief that life has a purpose, will, or way. The 14 items are rated on a 5-point Likert scale where "I totally disagree" = 1 and "I totally agree" = 5. Total scores range from 14 to 70 where higher scores indicate greater feelings of spiritual meaning.

    Measured: Baseline, up to 6 months

  38. Change in Telomere Length (TL)

    Telomeres are caps at the ends of chromosomes that, based on primary research, are shown to shorten each time a cell divides. Telomere length (TL) is used as is a marker of cellular aging as shorter telomeres indicate limited cellular life, an indicator of senescence, used overall to comment on longevity of those being measured. Population studies use telomere length (TL) in studies of population health and lifespan. Telomere length (TL) will be measured by blood sample analysis.

    Measured: Baseline, up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2019
  2. Study start11 Jan 2019
  3. Primary completion17 Sep 2019
  4. Study completion17 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03856892
Sponsor's protocol ID
IRB00107267
Acronym
Yoga
Status last verified
Oct 2023
First submitted
26 Feb 2019
Last updated
6 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data will be made available for sharing with other researchers following deidentification.

Questions about this trial

What is this clinical trial studying?

A study testing High Dose Yoga and Medium Dose Yoga in people with Stress, Physiological and Stress, Psychological, run by Emory University at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Heart Rate Variability (HRV) Between Study Arms (time frame: Baseline, up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.

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