StressR&RNCT01857830
The Relaxation vs. Retreat Study
A study testing Meditation Retreat and Active Comparator Relaxation Group in people with Stress and Ageing, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this research study is to examine whether a short term meditation intervention can improve health, mood, and biological markers of cellular stress and aging in novice and experienced meditators compared to controls. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- What is being tested?
- Meditation Retreat and Active Comparator Relaxation Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jul 2013
- 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 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Women
- Age 30-60
- "Novice Meditator" (meditates for 30 minutes per week or less) or "Experienced Meditator" (meditates at 40 or more per week and for more than 6 months, and are self-selected/enrolled in the retreat)
Who cannot join
- Current or history of a major medical condition (such as cancer, heart disease, autoimmune disease, diabetes)
- Smokers (have not smoked regularly for the past 6 months)
- Currently taking antidepressants
- Post Traumatic Stress Disorder
- Currently taking Hormone Replacement Therapy or birth control pills
Trial locations and contacts
1 site in 1 country.
United States1 site
Chopra Center for Wellbeing
Carlsbad, California, 92009
About this study
Official title: The Effect of a Short Term Meditation Retreat on Markers of Cellular Stress and Aging
The purpose of this research study is to examine whether a short term meditation intervention can improve health, mood, and biological markers of cellular stress and aging in novice and experienced meditators compared to controls.
Read the detailed description
There are 3 parts to this research study, Part A, B, and C.
In Part A, participants complete a brief online questionnaire sent to them via email by the study coordinator.
During Part B of the study, participants stay at La Costa Resort in Carlsbad, CA for 6 nights and participate in a meditation retreat being held at the resort, or stay at the resort without participating in the retreat. During their stay, participants attend two in-person research assessments throughout the week. Assessments will be 4 days (96 hours) apart for all participants and will include a fasting blood draw, body measurements, and self-report questionnaires.
Part C of the study includes a brief online questionnaire that is completed 1 month after participants leave La Costa Resort.
This study includes 3 groups: a group of "novice meditators" from the greater San Diego Region that are randomized into either the 1) Relaxation (Control) group or 2) Retreat group. The third group is comprised of self-selected "experienced meditators" who are already enrolled in the retreat. In total, 99 participants were recruited for this study.
The Retreat group stays at La Costa Resort and attends a 6 day meditation retreat intervention as well as completes all research study assessments and questionnaires.
The Relaxation (Control) group stays at La Costa Resort for 6 nights, but does not attend the meditation retreat. They attend once daily lectures on science topics and complete all research study assessments and questionnaires.
The Experienced Retreat group participants have an ongoing meditation practice and have enrolled themselves in the April 2013 meditation retreat. All of the Experienced meditators attend the meditation retreat and complete all research study assessments and questionnaires.
- Being tested
- Meditation Retreat, Active Comparator Relaxation Group
- Keywords
- Telomerase, Telomere Length, Psychological Stress, Amyloid beta proteins, Meditation
- Medical subject headings
- Stress, Psychological, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meditation RetreatBehavioural
The intervention is a one week meditation and yoga retreat hosted at the La Costa Resort and Spa in Carlsbad, CA.
Active Comparator Relaxation GroupBehavioural
Participants are randomized to stay at La Costa Resort and Spa for 6 days. Participants will receive daily meals similar to the meals for those in the retreat group. Participants will also receive a daily one hour lecture on topics related to longevity and health.
| Study group | Role | What they receive |
|---|---|---|
| Meditation Retreat Group | Experimental | Participants in this group will participate in a 6 day meditation retreat at the La Costa Resort and Spa in Carlsbad, CA. They will be self-selected to participate in the retreat or are novice meditators randomized into this retreat. Receives: Behavioral: Meditation Retreat |
| Relaxation/Control Group | Active comparator | Participants in this group will stay at La Costa Resort and spa for a 6 day period and will participate in the Active Comparator Relaxation Group activities (i.e. series of lectures on longevity and health, shared meals, and other leisure activities). Receives: Behavioral: Active Comparator Relaxation Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telomerase
Participants blood will be drawn by licensed phlebotomist on the day after their arrival at La Costa Resort at their baseline assessment and again 96 hours later at their follow-up assessment. Telomerase will be measured at both time points.
Measured: Change from Baseline in Telomerase 96 hours later
Secondary outcomes (5)
Amyloid Beta Proteins
Participants blood will be drawn by licensed phlebotomist on the day after their arrival at La Costa Resort at their baseline assessment and again 96 hours later at their follow-up assessment. Amyloid beta protein levels will be measured in the blood at both time points.
Measured: Change from baseline in Amyloid Beta Proteins, 96 hours later
Psychological Well being
We will collect self reported measures of vitality, purpose in life, perceived stress, rumination, self-compassion, mindfulness, presence in the moment, mind wandering, depression, acceptance and action, and body responsiveness in questionnaires. Participants complete questionnaires before arriving at La Costa (baseline), after their stay (follow-up) and one month after they leave (1-month follow-up). Additionally, they complete daily questionnaires that ask about their daily experiences (emotions, stress).
Measured: Change from Baseline in psychological well being at 96 hours, and 1 month later.
Oxytocin
Plasma is saved from baseline and 96 hour followup for oxytocin assays.
Measured: Change from baseline in Oxytocin at 96 hours later.
Telomere Length
Participants blood will be drawn by licensed phlebotomist on the day after their arrival at La Costa Resort at their baseline assessment and again 96 hours later at their follow-up assessment. Telomere Length will be measured at both time points.
Measured: Change from Baseline in Telomere Length, 96 hours later
Gene Expression
Participants blood will be drawn by licensed phlebotomist on the day after their arrival at La Costa Resort at their baseline assessment and again 96 hours later at their follow-up assessment. Patterns of gene expression (specifically on genes related to aging) will be measured at both time points.
Measured: Change from Baseline in Gene Expression, 96 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2013
- Study completionJul 2013
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 University of California, San FranciscoThe 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
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elissa Epel, PhD, Principal investigator, University of California, San FranciscoEli Puterman, PhD, Principal investigator, University of California, San FranciscoElizabeth Blackburn, PhD, Principal investigator, University of California, San FranciscoJue Lin, PhD, Principal investigator, University of California, San FranciscoSamantha Schilf, BA, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857830
- Sponsor's protocol ID
- 12-1039
- Acronym
- R&R
- Status last verified
- Aug 2013
- First submitted
- 25 Apr 2013
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Short Term Meditation Retreat on Markers of Cellular Stress and Aging
- ClinicalTrials.gov ID
- NCT01857830
- Acronym / sponsor ID
- R&R / 12-1039
- Keywords
- Telomerase, Telomere Length, Psychological Stress, Amyloid beta proteins, Meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 20 May 2013 (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 research study is to examine whether a short term meditation intervention can improve health, mood, and biological markers of cellular stress and aging in novice and experienced meditators compared to controls.
Detailed description
There are 3 parts to this research study, Part A, B, and C.
In Part A, participants complete a brief online questionnaire sent to them via email by the study coordinator.
During Part B of the study, participants stay at La Costa Resort in Carlsbad, CA for 6 nights and participate in a meditation retreat being held at the resort, or stay at the resort without participating in the retreat. During their stay, participants attend two in-person research assessments throughout the week. Assessments will be 4 days (96 hours) apart for all participants and will include a fasting blood draw, body measurements, and self-report questionnaires.
Part C of the study includes a brief online questionnaire that is completed 1 month after participants leave La Costa Resort.
This study includes 3 groups: a group of "novice meditators" from the greater San Diego Region that are randomized into either the 1) Relaxation (Control) group or 2) Retreat group. The third group is comprised of self-selected "experienced meditators" who are already enrolled in the retreat. In total, 99 participants were recruited for this study.
The Retreat group stays at La Costa Resort and attends a 6 day meditation retreat intervention as well as completes all research study assessments and questionnaires.
The Relaxation (Control) group stays at La Costa Resort for 6 nights, but does not attend the meditation retreat. They attend once daily lectures on science topics and complete all research study assessments and questionnaires.
The Experienced Retreat group participants have an ongoing meditation practice and have enrolled themselves in the April 2013 meditation retreat. All of the Experienced meditators attend the meditation retreat and complete all research study assessments and questionnaires.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meditation Retreat Group | Experimental | Behavioral: Meditation RetreatParticipants in this group will participate in a 6 day meditation retreat at the La Costa Resort and Spa in Carlsbad, CA. They will be self-selected to participate in the retreat or are novice meditators randomized into this retreat. |
| Relaxation/Control Group | Active comparator | Behavioral: Active Comparator Relaxation GroupParticipants in this group will stay at La Costa Resort and spa for a 6 day period and will participate in the Active Comparator Relaxation Group activities (i.e. series of lectures on longevity and health, shared meals, and other leisure activities). |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- Women
- Age 30-60
- "Novice Meditator" (meditates for 30 minutes per week or less) or "Experienced Meditator" (meditates at 40 or more per week and for more than 6 months, and are self-selected/enrolled in the retreat)
Key exclusion criteria (5 listed)
- Current or history of a major medical condition (such as cancer, heart disease, autoimmune disease, diabetes)
- Smokers (have not smoked regularly for the past 6 months)
- Currently taking antidepressants
- Post Traumatic Stress Disorder
- Currently taking Hormone Replacement Therapy or birth control pills
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 |
|---|---|---|
| Meditation RetreatThe intervention is a one week meditation and yoga retreat hosted at the La Costa Resort and Spa in Carlsbad, CA. | Behavioural | Meditation Retreat Group |
| Active Comparator Relaxation GroupParticipants are randomized to stay at La Costa Resort and Spa for 6 days. Participants will receive daily meals similar to the meals for those in the retreat group. Participants will also receive a daily one hour lecture on topics related to longevity and health. | Behavioural | Relaxation/Control Group |
Primary outcome
Telomerase
Time frame: Change from Baseline in Telomerase 96 hours later
Participants blood will be drawn by licensed phlebotomist on the day after their arrival at La Costa Resort at their baseline assessment and again 96 hours later at their follow-up assessment. Telomerase will be measured at both time points.
5 secondary outcomes
Amyloid Beta Proteins
Time frame: Change from baseline in Amyloid Beta Proteins, 96 hours later
Psychological Well being
Time frame: Change from Baseline in psychological well being at 96 hours, and 1 month later.
Oxytocin
Time frame: Change from baseline in Oxytocin at 96 hours later.
Telomere Length
Time frame: Change from Baseline in Telomere Length, 96 hours later
Gene Expression
Time frame: Change from Baseline in Gene Expression, 96 hours later
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 21 Aug 2013.
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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.
Elissa Epel, PhD principal investigator
University of California, San Francisco
Eli Puterman, PhD principal investigator
University of California, San Francisco
Elizabeth Blackburn, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation Retreat and Active Comparator Relaxation Group in people with Stress and Ageing, run by University of California, San Francisco 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 4 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 21 Aug 2013. 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?
Telomerase (time frame: Change from Baseline in Telomerase 96 hours later). 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 21 Aug 2013.