How Body Awareness Promotes Mental Health During Yoga and Physical Exercise
1 other identifier
interventional
71
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2018
CompletedStudy Start
First participant enrolled
March 1, 2018
CompletedFirst Posted
Study publicly available on registry
June 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2021
CompletedFebruary 25, 2021
February 1, 2021
3 years
March 1, 2018
February 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Interoceptive Acuity
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.
14 weeks
Secondary Outcomes (1)
Peripheral Inflammatory Markers of Stress by collecting Dried Blood Spot (DBS)
14 weeks
Study Arms (3)
Gentle Yoga Program
EXPERIMENTALProgram 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.
Rigorous Yoga Program
EXPERIMENTALProgram 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.
Cardiovascular Exercise Program
EXPERIMENTALProgram 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.
Interventions
10-week exercise program structured around gentle yoga practice.
10-week exercise program structured around rigorous yoga practice.
10-week exercise program structured around cardiovascular exercise.
Eligibility Criteria
You may qualify if:
- years of age
- Have negative mood symptoms (depression, anxiety, stress)
- Is healthy and independent enough in daily life to attend study classes
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Yoga Science Foundationcollaborator
- University of Torontocollaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02129, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Sara Lazar, PhD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 1, 2018
First Posted
June 12, 2018
Study Start
March 1, 2018
Primary Completion
February 23, 2021
Study Completion
February 23, 2021
Last Updated
February 25, 2021
Record last verified: 2021-02