HealthyPhase 2NCT00179595
Does the Relaxation Response Inhibit Acute Stress?
A Phase 2 study testing relaxation response- meditation in people with Healthy, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purposes of this study are: 1. To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults. 2. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- relaxation response- meditation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Oct 2011
- Phase
- Phase 2
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy individual
- age:18-49 years
- able to read and understand English
- able to attend al study visits
- access to a telephone (to schedule visits)
Who cannot join
- current smoking
- asthma
- current use of any prescription or psychoactive medications or supplements
- either:
- no prior experience with RR eliciting techniques
- at least 3 years of regular RR elicitation (at least 20 min/day)
Show all 10Show fewer
- BMI >30
- exhaled nitric oxide levels >60 ppb
- abnormal lab values (Hct <32,creatinine >1.3, glucose >200
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth-Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The purposes of this study are:
- To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.
- To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.
Since stress is a factor in the development of many health conditions, a further understanding of the mechanisms of the RR should be developed. The project is designed to determine how the RR can improve the quality of life that has been adversely affected by stress.
Read the detailed description
The purposes of this study are:
- To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.
- To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.
Since stress is a factor in the development of many health conditions, a further understanding of the mechanisms of the RR should be developed. The project is designed to determine how the RR can improve the quality of life that has been adversely affected by stress.
- Conditions
- Healthy
- Being tested
- relaxation response- meditation
- Keywords
- nitric oxide, volumetric oxygen consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relaxation response- meditationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.
Secondary outcomes (1)
To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMay 2002
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Herbert Benson, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179595
- Sponsor's protocol ID
- 2001P001747
- Other IDs
- H75-CCH-123424, H75-CCH-119124
- Status last verified
- Feb 2017
- First submitted
- 13 Sep 2005
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Relaxation Response Inhibit Acute Stress?
- ClinicalTrials.gov ID
- NCT00179595
- Acronym / sponsor ID
- 2001P001747
- Conditions
- Healthy
- Keywords
- nitric oxide, volumetric oxygen consumption
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- May 2002
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 16 Sep 2005 (estimated)
- 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 purposes of this study are:
- To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.
- To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.
Since stress is a factor in the development of many health conditions, a further understanding of the mechanisms of the RR should be developed. The project is designed to determine how the RR can improve the quality of life that has been adversely affected by stress.
Detailed description
The purposes of this study are:
- To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.
- To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.
Since stress is a factor in the development of many health conditions, a further understanding of the mechanisms of the RR should be developed. The project is designed to determine how the RR can improve the quality of life that has been adversely affected by stress.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy individual
- age:18-49 years
- able to read and understand English
- able to attend al study visits
- access to a telephone (to schedule visits)
Key exclusion criteria (10 listed)
- current smoking
- asthma
- current use of any prescription or psychoactive medications or supplements
- either:
- BMI >30
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 |
|---|---|---|
| relaxation response- meditation | Behavioural | – |
Primary outcome
To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.
1 secondary outcome
To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.
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 16 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Herbert Benson, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing relaxation response- meditation in people with Healthy, run by Beth Israel Deaconess Medical Center 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 5 inclusion and 10 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 16 Feb 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.. 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 16 Feb 2017; AzTrials last refreshed its copy on 5 Nov 2026.