Kaivalyadhama Yoga Institute
Lonavla, Maharashtra, 410403, India
NCT Number: NCT03856892
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Lonavla, Maharashtra, 410403, India
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline, up to 6 months
Heart rate variability (HRV) is measured by electrocardiogram.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
Skin conductance level (SCL) is measured by electrodermal activity (EDA).
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
Skin conductance response is measured by electrodermal activity (EDA).
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
Oxidative stress will be measured by ROS levels.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
Change in TAS will be measured by blood sample analysis.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
Self-assessment questions covering "how do you feel", with ongoing 3 daily-based questions once a week.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
Brain-derived neurotrophic factor is a member of the neurotrophin family of growth factors, will be measured by blood sample analysis.
Time frame: Baseline, up to 6 months
Change in Growth Hormone level will be measured by blood sample analysis.
Time frame: Baseline, up to 6 months
Change in Oxytocin level will be measured by blood sample analysis.
Time frame: Baseline, up to 6 months
Change in Ghrelin level will be measured by blood sample analysis.
Time frame: Baseline, up to 6 months
Change in Leptin level will be measured by blood sample analysis.
Emory University
Other
Acronym: Yoga
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05523414
Anxiety, Anxiety Disorders
San Diego, California, United States
View Trial DetailsNCT06573034
Behavior, Behavioral Symptoms
Charlotte, North Carolina, United States
View Trial DetailsNCT07220421
Anxiety Disorders, Behavior
Boston, Massachusetts, United States
View Trial DetailsNCT05589571
Behavior, Behavioral Symptoms
Boca Raton, Florida, United States
View Trial Details