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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Negative Thoughts Mild Depression Stress Behavioral: Gentle Yoga Intervention Behavioral: Rigorous Yoga Intervention Behavioral: Physical Exercise Intervention Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: How Body Awareness Promotes Mental Health During Yoga and Physical Exercise
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : June 16, 2019
Estimated Study Completion Date : December 4, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: Gentle Yoga Intervention
10-week exercise program structured around gentle yoga practice.

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.
Behavioral: Rigorous Yoga Intervention
10-week exercise program structured around rigorous yoga practice.

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.
Behavioral: Physical Exercise Intervention
10-week exercise program structured around cardiovascular exercise.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553745


Contacts
Contact: Muhlis B Cindik 617-643-6628 stressreducion@partners.org
Contact: Tanaporn Ormtavesub 617-643-6628 stressreduction@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02129
Contact: Sara Lazar, PhD    617-643-6628    lazar@nmr.mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Yoga Science Foundation
University of Toronto
Investigators
Principal Investigator: Sara Lazar, PhD Mass. General Hospital

Responsible Party: Sara W Lazar, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03553745     History of Changes
Other Study ID Numbers: 2017P001710
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No