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.
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.
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.
- Conditions
- Stress, Physiological, Stress, Psychological
- 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 group | Role | What they receive |
|---|---|---|
| Active Study Group | Experimental | Participants 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 Control | Active comparator | Participants 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 Control | No intervention | Participants 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.
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)
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
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
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
Change in Skin Conductance Response Between Study Arms
Skin conductance response is measured by electrodermal activity (EDA).
Measured: Baseline, up to 6 months
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
Change in Reactive Oxygen Species (ROS) Levels Between Study Arms
Oxidative stress will be measured by ROS levels.
Measured: Baseline, up to 6 months
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted27 Feb 2019
- Study start11 Jan 2019
- Primary completion17 Sep 2019
- Study completion17 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PhysiologicalStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carol Worthman, Emory University
- Investigators
- Paul Dallaghan, PhD, Principal investigator, Emory University
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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breath, Stress and Health: a Biocultural Study of Hatha Yoga Practice
- ClinicalTrials.gov ID
- NCT03856892
- Acronym / sponsor ID
- Yoga / IRB00107267
- Conditions
- Stress, Physiological, Stress, Psychological
- Keywords
- Yoga, Breath-based yoga, Stress management, Meditation, Hatha yoga, Anxiety mitigation, Mental health, Longevity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Study Group | Experimental | Other: High Dose YogaParticipants 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. |
| Active Control | Active comparator | Other: Medium Dose YogaParticipants 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 |
| Passive Control | No intervention | –Participants randomized to the Passive Control study arm do not receive a study intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Dose YogaParticipants 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. | Other | Active Study Group |
| Medium Dose YogaThe "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. | Other | Active Control |
Primary outcome
Change in Heart Rate Variability (HRV) Between Study Arms
Time frame: Baseline, up to 6 months
Heart rate variability (HRV) is measured by electrocardiogram.
38 secondary outcomes
Change in Heart Rate Variability (HRV) Between High and Low Participation Level
Time frame: Baseline, up to 6 months
Change in Skin Conductance Level (SCL) Between Study Arms
Time frame: Baseline, up to 6 months
Change in Skin conductance level (SCL) Between High and Low Participation Level
Time frame: Baseline, up to 6 months
Change in Skin Conductance Response Between Study Arms
Time frame: Baseline, up to 6 months
Change in Skin Conductance Response Between High and Low Participation Level
Time frame: Baseline, up to 6 months
Change in Reactive Oxygen Species (ROS) Levels Between Study Arms
Time frame: Baseline, up to 6 months
Change in Reactive Oxygen Species (ROS) Between High and Low Participation Level
Time frame: Baseline, up to 6 months
Change in Total Antioxidant Status (TAS) Between Study Arms
Time frame: Baseline, up to 6 months
Change in Total Antioxidant Status (TAS) Between High and Low Participation Level
Time frame: Baseline, up to 6 months
Change in Levels of Antioxidant Enzyme Glutathione (GSH) Between Study Arms
Time frame: Baseline, up to 6 months
Change in levels of antioxidant enzyme Glutathione (GSH) Between High and Low Participation Level
Time frame: Baseline, up to 6 months
Change in Levels of Circulating IL-6 Between Study Arms
Time frame: Baseline, up to 6 months
Change in levels of circulating IL-6 Between High and Low Participation Level
Time frame: Baseline, up to 6 months
Change in Levels of Circulating Tumor-Necrosis Factor-alpha (TNF-α) Between Study Arms
Time frame: Baseline, up to 6 months
Change in levels of circulating TNF-α Between High and Low Participation Level
Time frame: Baseline, up to 6 months
Change in Upper Abdominal Muscle Tension Between Study Arms
Time frame: Baseline, up to 6 months
Change in Upper Abdominal Muscle Tension Between High and Low Participation Level
Time frame: Baseline, up to 6 months
Change in Self-assessment Questions Covering "how do you feel" score
Time frame: Baseline, up to 6 months
Change in Perceived Stress Reactivity Scale (PSRS) Score
Time frame: Baseline, up to 6 months
Change in Perceived Stress Scale (PSS) Score
Time frame: Baseline, up to 6 months
Change in Difficulties in Emotion Regulation Scale (DERS) Score
Time frame: Baseline, up to 6 months
Change in Depression Anxiety and Stress Scale (DASS) Score
Time frame: Baseline, up to 6 months
Change in Penn State Worry Questionnaire (PSWQ) Score
Time frame: Baseline, up to 6 months
Change in Positive and Negative Affect Scale (PANAS) Score
Time frame: Baseline, up to 6 months
Change in Beck Depression Inventory (BDI-II) Score
Time frame: Baseline, up to 6 months
Change in Beck Anxiety Inventory (BAI-II) Score
Time frame: Baseline, up to 6 months
Change in Profile of Mood States (POMS) Score
Time frame: Baseline, up to 6 months
Change in Coping Self-efficacy Scale (CSES) Score
Time frame: Baseline, up to 6 months
Changes in Multidimensional Assessment of Interoceptive Awareness (MAIA) 8-Subscale Scores
Time frame: Baseline, up to 6 months
Change in Mindful Attention Awareness Scale (MAAS) Score
Time frame: Baseline, up to 6 months
Change in Compassion Scale (CS) Score
Time frame: Baseline, up to 6 months
Change in Self-Compassion Scale - Short Form (SCS-SF) Score
Time frame: Baseline, up to 6 months
Change in Five Facet Mindfulness Questionnaire (FFMQ) Score
Time frame: Baseline, up to 6 months
Change in Heartland Forgiveness Scale Score
Time frame: Baseline, up to 6 months
Change in Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) Score
Time frame: Baseline, up to 6 months
Change in Gratitude Questionnaire - Six Item Form (GQ-6) Score
Time frame: Baseline, up to 6 months
Change in Spiritual Meaning Scale (SMS) Score
Time frame: Baseline, up to 6 months
Change in Telomere Length (TL)
Time frame: Baseline, up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Individual participant dataSharing planned: Yes. Individual participant data will be made available for sharing with other researchers following deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Dallaghan, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
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.