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How Body Awareness Promotes Mental Health During Yoga and Physical Exercise

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ClinicalTrials.gov Identifier: NCT03553745
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Collaborators:
Yoga Science Foundation
University of Toronto
Information provided by (Responsible Party):
Sara W Lazar, Massachusetts General Hospital

March 1, 2018
June 12, 2018
June 12, 2018
March 1, 2018
June 16, 2019   (Final data collection date for primary outcome measure)
Change in Interoceptive Acuity [ Time Frame: 14 weeks ]
Interoceptive acuity will be assessed at baseline, week 12 and week 14. Data collection at three time points will be used to assess changes in interoceptive acuity over the timeline.
Same as current
No Changes Posted
Peripheral Inflammatory Markers of Stress by collecting Dried Blood Spot (DBS) [ Time Frame: 14 weeks ]
Dried Blood Spot (DBS) will be collected at baseline, week 12 and week 14. This will be used to assess changes in levels of peripheral markers of inflammation (C-reactive protein, cytokines [IL-6]) in the blood as an indicator of stress.
Same as current
Not Provided
Not Provided
 
How Body Awareness Promotes Mental Health During Yoga and Physical Exercise
How Body Awareness Promotes Mental Health During Yoga and Physical Exercise
The integrity of interoceptive networks is linked to resilience against depressive symptoms, whereas degradation of these networks is linked to apathy and deficits in emotion processing. The goal of this study is to compare two major styles of yoga and cardiovascular exercise through a 10-week training program to promote interoceptive awareness. The researchers hypothesize that improvement in affective symptomatology will be correlated with better interoceptive development. Changes in mood related symptoms and interoception will be assessed at baseline, week 12 and week 14, in a cohort of adults aged 18-55.
A recent annual survey of U.S. college freshman has found consistently declining levels of emotional health over the past 25 years. Exposure to such stress can have profound longitudinal effects on well being, influencing risk for disease later in life. Physical exercise is linked to benefits across a variety of physical and psychological domains. While the affective and physiological consequences of exercise are well-documented, how they work to improve subjective well-being is unclear. It has been suggested that exercise promotes well-being by increasing interoception. The integrity of interoceptive networks is linked to resilience against depressive symptoms, whereas degradation of these networks is linked to apathy and deficits in emotion processing. The goal of this study is to compare two major styles of yoga and cardiovascular exercise through a 10-week training program to promote interoceptive awareness. The researchers hypothesize that improvement in affective symptomatology will be correlated with better interoceptive development. Changes in mood related symptoms and interoception will be assessed at baseline, week 12 and week 14, in a cohort of adults aged 18-55.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Negative Thoughts
  • Mild Depression
  • Stress
  • Behavioral: Gentle Yoga Intervention
    10-week exercise program structured around gentle yoga practice.
  • Behavioral: Rigorous Yoga Intervention
    10-week exercise program structured around rigorous yoga practice.
  • Behavioral: Physical Exercise Intervention
    10-week exercise program structured around cardiovascular exercise.
  • Experimental: Gentle Yoga Program
    Program will meet twice a week for a 10-week period. Participants will be a part of gentle yoga sessions led by instructors specializing in the area.
    Intervention: Behavioral: Gentle Yoga Intervention
  • Experimental: Rigorous Yoga Program
    Program will meet twice a week for a 10-week period. Participants will be a part of rigorous yoga sessions led by instructors specializing in the area.
    Intervention: Behavioral: Rigorous Yoga Intervention
  • Experimental: Cardiovascular Exercise Program
    Program will meet twice a week for a 10-week period. Participants will be a part of cardiovascular exercise sessions led by instructors specializing in the area.
    Intervention: Behavioral: Physical Exercise Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Same as current
December 4, 2019
June 16, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18-55 years of age
  • Have negative mood symptoms (depression, anxiety, stress)
  • Is healthy and independent enough in daily life to attend study classes

Exclusion Criteria:

  • Pregnant women or women who are planning to become pregnant during the study period
  • History of structural brain disease, mass lesion, stroke, epilepsy
  • History of addictive disorder or significant substance abuse
  • Neurological disorders or reversible causes of dementia
  • Suicidality or history of psychosis
  • Currently attending regular yoga or aerobic exercise practice, or participated in more than 6 formal meditation, aerobic, or yoga classes in the past 12 months
  • Self-reported cognitive impairment and other disorders which may preclude safe participation in the program including acute major depression, bipolar or severe personality disorder
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact: Muhlis B Cindik 617-643-6628 stressreducion@partners.org
Contact: Tanaporn Ormtavesub 617-643-6628 stressreduction@partners.org
United States
 
 
NCT03553745
2017P001710
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Sara W Lazar, Massachusetts General Hospital
Massachusetts General Hospital
  • Yoga Science Foundation
  • University of Toronto
Principal Investigator: Sara Lazar, PhD Mass. General Hospital
Massachusetts General Hospital
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP