- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03553745
How Body Awareness Promotes Mental Health During Yoga and Physical Exercise
February 23, 2021 updated by: Sara W Lazar, Massachusetts General Hospital
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 Overview
Status
Completed
Conditions
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
Enrollment (Actual)
71
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02129
- Massachusetts General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
10-week exercise program structured around cardiovascular exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
14 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2018
Primary Completion (Actual)
February 23, 2021
Study Completion (Actual)
February 23, 2021
Study Registration Dates
First Submitted
March 1, 2018
First Submitted That Met QC Criteria
May 30, 2018
First Posted (Actual)
June 12, 2018
Study Record Updates
Last Update Posted (Actual)
February 25, 2021
Last Update Submitted That Met QC Criteria
February 23, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017P001710
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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