StressPhase 2NCT00179569
Molecular Processes of the Relaxation Response in Older Adults
A Phase 2 study testing Relaxation response in people with Stress, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to examine the molecular (nitric oxide) and biochemical (epinephrine, norepinephrine, cortisol and ACTH) parameters that are associated with RR elicitation and which may counteract the effects of acute stress in the elderly. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Relaxation response
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Sep 2007
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60-80 years of age
- healthy individuals
- willing and able to attend treatment sessions
- willing to learn how to do and practice the relaxation-response
- access to a working telephone
- read and write English
Who cannot join
- Major medical or psychiatric illness
- asthma or seasonal allergies (resulting in nitric oxide levels >60 ppb)
- smoking
- previous relaxation-response practice
- current use of the following medications:systemic corticosteroids, anti-convulsants/psychotics, immunosuppressants, cytotoxic therapy, anabolic steroids, antidepressants (other than SSRIs), dicyclomine, bile acid binding resins, or sympathomimetic medication
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the molecular (nitric oxide) and biochemical (epinephrine, norepinephrine, cortisol and ACTH) parameters that are associated with RR elicitation and which may counteract the effects of acute stress in the elderly.
- Conditions
- Stress
- Being tested
- Relaxation response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation responseBehavioural
8 weeks of relaxation response training
What is being measured
The primary outcome is the main question the study is designed to answer.
A primary goal of this study is to quantify the magnitude of relaxation response elicitation by comparing oxygen consumption during rest versus during elicitation of the relaxation response in a sample of healthy older adults.
Measured: 8 weeks
Secondary outcomes (1)
A second area of interest is the relationship between exhaled levels of nitric oxide (NO) and oxygen consumption (VO2) during relaxation response elicitation.
Measured: 8 weeks
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 startAug 2005
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 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
- Investigators
- Jeffery A Dusek, PhD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179569
- Sponsor's protocol ID
- 2004P-000418
- Other IDs
- H75-CCH-123424, H75-CCH-119124
- Status last verified
- Nov 2007
- First submitted
- 13 Sep 2005
- Last updated
- 5 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Processes of the Relaxation Response in Older Adults
- ClinicalTrials.gov ID
- NCT00179569
- Acronym / sponsor ID
- 2004P-000418
- Conditions
- Stress
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Aug 2005
- Study completion
- Sep 2007 (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 purpose of this study is to examine the molecular (nitric oxide) and biochemical (epinephrine, norepinephrine, cortisol and ACTH) parameters that are associated with RR elicitation and which may counteract the effects of acute stress in the elderly.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 60-80 years of age
- healthy individuals
- willing and able to attend treatment sessions
- willing to learn how to do and practice the relaxation-response
- access to a working telephone
Key exclusion criteria (5 listed)
- Major medical or psychiatric illness
- asthma or seasonal allergies (resulting in nitric oxide levels >60 ppb)
- smoking
- previous relaxation-response practice
- current use of the following medications:systemic corticosteroids, anti-convulsants/psychotics, immunosuppressants, cytotoxic therapy, anabolic steroids, antidepressants (other than SSRIs), dicyclomine, bile acid binding resins, or sympathomimetic medication
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 response8 weeks of relaxation response training | Behavioural | – |
Primary outcome
A primary goal of this study is to quantify the magnitude of relaxation response elicitation by comparing oxygen consumption during rest versus during elicitation of the relaxation response in a sample of healthy older adults.
Time frame: 8 weeks
1 secondary outcome
A second area of interest is the relationship between exhaled levels of nitric oxide (NO) and oxygen consumption (VO2) during relaxation response elicitation.
Time frame: 8 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 5 Nov 2007.
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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.
Jeffery A Dusek, PhD 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 in people with Stress, 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 6 inclusion and 5 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 5 Nov 2007. 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?
A primary goal of this study is to quantify the magnitude of relaxation response elicitation by comparing oxygen consumption during rest versus during elicitation of the relaxation response in a sample of healthy older adults. (time frame: 8 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 5 Nov 2007.