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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03553745
Other study ID # 2017P001710
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date February 23, 2021

Study information

Verified date February 2021
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 71
Est. completion date February 23, 2021
Est. primary completion date February 23, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Gentle Yoga Intervention
10-week exercise program structured around gentle yoga practice.
Rigorous Yoga Intervention
10-week exercise program structured around rigorous yoga practice.
Physical Exercise Intervention
10-week exercise program structured around cardiovascular exercise.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Massachusetts General Hospital University of Toronto, Yoga Science Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Peripheral Inflammatory Markers of Stress by collecting Dried Blood Spot (DBS) 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
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