Negative ThoughtsNCT03553745
How Body Awareness Promotes Mental Health During Yoga and Physical Exercise
A study testing Gentle Yoga Intervention, Rigorous Yoga Intervention and Physical Exercise Intervention in people with Negative Thoughts and Mild Depression, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Negative Thoughts, Mild Depression, Stress
- What is being tested?
- Gentle Yoga Intervention, Rigorous Yoga Intervention and Physical Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 23 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-55 years of age
- Have negative mood symptoms (depression, anxiety, stress)
- Is healthy and independent enough in daily life to attend study classes
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02129
About this study
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.
Read the 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.
- Conditions
- Negative Thoughts, Mild Depression, Stress
- Being tested
- Gentle Yoga Intervention, Rigorous Yoga Intervention, Physical Exercise Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentle Yoga InterventionBehavioural
10-week exercise program structured around gentle yoga practice.
Rigorous Yoga InterventionBehavioural
10-week exercise program structured around rigorous yoga practice.
Physical Exercise InterventionBehavioural
10-week exercise program structured around cardiovascular exercise.
| Study group | Role | What they receive |
|---|---|---|
| Gentle Yoga Program | Experimental | 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. Receives: Behavioral: Gentle Yoga Intervention |
| Rigorous Yoga Program | Experimental | 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. Receives: Behavioral: Rigorous Yoga Intervention |
| Cardiovascular Exercise Program | Experimental | 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. Receives: Behavioral: Physical Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 weeks
Secondary outcomes (1)
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.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start1 Mar 2018
- Primary completion23 Feb 2021
- Study completion23 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Negative ThoughtsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Yoga Science Foundation, University of Toronto
- Responsible party
- Principal investigator, Sara W Lazar, Massachusetts General Hospital
- Investigators
- Sara Lazar, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553745
- Sponsor's protocol ID
- 2017P001710
- Status last verified
- Feb 2021
- First submitted
- 1 Mar 2018
- Last updated
- 25 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Body Awareness Promotes Mental Health During Yoga and Physical Exercise
- ClinicalTrials.gov ID
- NCT03553745
- Acronym / sponsor ID
- 2017P001710
- Conditions
- Negative Thoughts, Mild Depression, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Yoga Science Foundation, University of Toronto
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 23 Feb 2021 (actual)
- Study completion
- 23 Feb 2021 (actual)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gentle Yoga Program | Experimental | Behavioral: Gentle Yoga InterventionProgram 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 | Experimental | Behavioral: Rigorous Yoga InterventionProgram 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 | Experimental | Behavioral: Physical Exercise InterventionProgram 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-55 years of age
- Have negative mood symptoms (depression, anxiety, stress)
- Is healthy and independent enough in daily life to attend study classes
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gentle Yoga Intervention10-week exercise program structured around gentle yoga practice. | Behavioural | Gentle Yoga Program |
| Rigorous Yoga Intervention10-week exercise program structured around rigorous yoga practice. | Behavioural | Rigorous Yoga Program |
| Physical Exercise Intervention10-week exercise program structured around cardiovascular exercise. | Behavioural | Cardiovascular Exercise Program |
Primary outcome
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.
1 secondary outcome
Peripheral Inflammatory Markers of Stress by collecting Dried Blood Spot (DBS)
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Lazar, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gentle Yoga Intervention, Rigorous Yoga Intervention and Physical Exercise Intervention in people with Negative Thoughts and Mild Depression, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Interoceptive Acuity (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.