AgingNCT03056105
The Psychobiological Effects of Participation in a One-Month Insight Meditation Retreat
An observational study of Aging, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study was to examine how participation in a 1 month intensive Insight (vipassana) Meditation retreat (a) affects biological markers of cellular aging, social affiliation, and inflammation, which are important for physical health, longevity, and behavior, and (b) to relate observed biological… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Residential Insight Meditation Retreat
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2013to 4 Feb 2014
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults with meditation experience
Who may be able to join
- Previous meditation experience equivalent to two 5-10 day residential meditation retreats
Who cannot join
- Disclosure of potentially contagious blood-borne illness (e.g., HIV, Hepatitis, etc.) or other illnesses that might interfere with telomere or telomerase measurement
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Davis, California, 95616
About this study
Official title: The Psychobiological Effects of a One-Month Insight Meditation Retreat, a Sub-study of The Shamatha Project: A Longitudinal, Randomized Waitlist Control Study of Cognitive, Emotional, and Neural Effects of Intensive Meditation Training
The purpose of this study was to examine how participation in a 1 month intensive Insight (vipassana) Meditation retreat (a) affects biological markers of cellular aging, social affiliation, and inflammation, which are important for physical health, longevity, and behavior, and (b) to relate observed biological changes to baseline levels and changes in psychological traits, which may underlie improvements in personal adaptive functioning.
Read the detailed description
The investigators are specifically assessing the effects of retreat on telomere length and telomerase levels in participants' white blood cells, as well as plasma levels of interlukin-6 (IL-6), to assess how the retreat experience impacts these markers of cellular aging and inflammation. The hypotheses are that retreat participation will increase both telomere length and telomerase activity, but decrease IL-6 levels. The investigators will also assess the impact of retreat participation on oxytocin-a hormone involved in a number of physiological and behavioral processes, including affiliative bonds and stress responses-the hypothesis being that participation in the retreat will increase plasma oxytocin levels. The investigators will then explore how these and other biomarkers relate to psychological processes and personality traits, which may also be altered by participation in the meditation retreat.
- Conditions
- Aging
- Being tested
- Residential Insight Meditation Retreat
- Keywords
- Well-being, affiliation, inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Residential Insight Meditation RetreatOther
Retreats at Spirit Rock Meditation Center were led by teams of 6 experienced teachers. Participants practiced "noble silence"-refraining from eye contact as well as verbal and written communication-except during meetings with teachers. Teachers lead guided Insight meditation practices, as well as meditations on loving-kindness, compassion, empathetic joy, and equanimity. The daily schedule consisted of sitting and walking meditation sessions (30-45 mins) totaling 8-10 hours/day, meals, and short work meditations (sweeping, dishes, etc.). Seated meditation was practiced as a group in a meditation hall with approximately 80 participants. Walking meditation took place in adjoining halls or on the grounds. Participants lived on-site during the retreat and were provided with a vegetarian diet.
| Study group | Role | What they receive |
|---|---|---|
| Retreat | Participants registered for a one-month, residential Insight Meditation retreat held at Spirit Rock Meditation Center in either February or March, 2013 Receives: Other: Residential Insight Meditation Retreat | |
| Comparison | Experienced meditators from the Spirit Rock Meditation Community |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telomerase
an enzyme that repairs the shortening of telomeres that occurs during aging
Measured: change from the start of retreat to three weeks into the retreat period
Telomere length
the repetitive sequence of DNA that serves as a protective cap to eukaryotic chromosomes, which protects from degradation and instability and is related to longevity
Measured: change from the start of retreat to three weeks into the retreat period
Interleukin-6
a primary measure of inflammation, which is influenced by psychological stress
Measured: change from the start of retreat to three weeks into the retreat period
Oxytocin
an affiliative hormone associated with social bonding in both men and women, and which downregulates inflammatory cytokines
Measured: change from the start of retreat to three weeks into the retreat period
Secondary outcomes (16)
Arginine Vasopressin
a less commonly studied affiliative hormone also associated with close social bonds
Measured: two measurements, three weeks apart
Brain Derived Neurotrophic Factor
a protein related to neuroplasticity, learning, and memory, which is decreased in depression
Measured: two measurements, three weeks apart
pro- and anti-inflammatory cytokines (IL-1b, IL-2, IL-4, IL-5, IL-10, IL-12 (p70), IL-13, IFN-γ, TNF-α)
a family of proteins involved in generating and regulating the immune system
Measured: two measurements, three weeks apart
State-Trait Anxiety Inventory
10 item scale designed to assess trait-anxiety (STAI; Spielberger et al., 1983)
Measured: two measurements, three weeks apart
Lifestyle Profile II
Assesses health-promoting lifestyle factors (Walker et al., 1987)
Measured: two measurements, three weeks apart
Experience in Close Relationships, short form
Assesses attachment anxiety (fear of rejection or abandonment) and avoidance (avoidance of intimacy and interdependence) (ECR-12: Lafontaine et al., 2015)
Measured: two measurements, three weeks apart
Mysticism Scale
Assesses mystical experience and religious interpretation (M-Scale; Hood, 1975)
Measured: two measurements, three weeks apart
Non-attachment Scale
Assesses non-attachment from a Buddhist perspective (NAS; Sahdra, Shaver \& Brown, 2010)
Measured: two measurements, three weeks apart
Self-Assessed Wisdom Scale
Assess five dimensions of wisdom: 1) Experience, 2) Emotional Regulation, 3) Reminiscence and Reflectiveness, 4) Openness, 5) Humor (SAWS; Webster, 2003)
Measured: two measurements, three weeks apart
Ego Resiliency Scale
Assesses the ability to adapt one's level of control temporarily up or down as circumstances dictate (EGO; Block \& Kremen, 1996)
Measured: two measurements, three weeks apart
Five Facet Mindfulness Questionnaire
Assesses five facets of mindfulness: 1) Non-reactivity to Inner Experience, 2) Observing 3) Acting with Awareness, 4) Describing, and 5) Non-judging of Experience (FFMQ; Baer et al., 2006)
Measured: two measurements, three weeks apart
Center for Epidemiological Studies Depression Scale
Assesses depressive symptomatology (CES-D; Radloff, 1977)
Measured: two measurements, three weeks apart
Psychological Wellbeing Scale
Assess autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance (PWBS; Ryff, 1989)
Measured: two measurements, three weeks apart
Three Dimensional Wisdom Scale
Assess three dimensions of wisdom: 1) Cognitive, 2) Reflective, and 3) Affective (3-DWS; Ardelt, 2003)
Measured: two measurements, three weeks
Big Five Inventory
Assesses extraversion, agreeableness, conscientiousness, openness to experience, neuroticism (BFI; Goldberg, 1993)
Measured: two measurements, three weeks
Difficulties in Emotion Regulation Scale
Assesses non-acceptance to one's emotional responses, difficulty achieving goals, impulsiveness, lack of emotional awareness, access to emotion regulation strategies, emotional clarity (DERS; Gratz \& Roemer, 2004)
Measured: two measurements, three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start3 Feb 2013
- Primary completion4 Feb 2014
- Study completion4 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, University of Barcelona
- Responsible party
- Sponsor
- Investigators
- Clifford D Saron, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056105
- Sponsor's protocol ID
- 230734
- Status last verified
- May 2017
- First submitted
- 10 Feb 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Conklin QA, King BG, Zanesco AP, Lin J, Hamidi AB, Pokorny JJ, Alvarez-Lopez MJ, Cosin-Tomas M, Huang C, Kaliman P, Epel ES, Saron CD. Insight meditation and telomere biology: The effects of intensive retreat and the moderating role of personality. Brain Behav Immun. 2018 May;70:233-245. doi: 10.1016/j.bbi.2018.03.003. Epub 2018 Mar 5.
PubMed 29518528
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Psychobiological Effects of a One-Month Insight Meditation Retreat, a Sub-study of The Shamatha Project: A Longitudinal, Randomized Waitlist Control Study of Cognitive, Emotional, and Neural Effects of Intensive Meditation Training
- ClinicalTrials.gov ID
- NCT03056105
- Acronym / sponsor ID
- 230734
- Conditions
- Aging
- Keywords
- Well-being, affiliation, inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- University of California, San Francisco, University of Barcelona
- Study start
- 3 Feb 2013 (actual)
- Primary completion
- 4 Feb 2014 (actual)
- Study completion
- 4 Feb 2014 (actual)
- First posted
- 17 Feb 2017 (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 purpose of this study was to examine how participation in a 1 month intensive Insight (vipassana) Meditation retreat (a) affects biological markers of cellular aging, social affiliation, and inflammation, which are important for physical health, longevity, and behavior, and (b) to relate observed biological changes to baseline levels and changes in psychological traits, which may underlie improvements in personal adaptive functioning.
Detailed description
The investigators are specifically assessing the effects of retreat on telomere length and telomerase levels in participants' white blood cells, as well as plasma levels of interlukin-6 (IL-6), to assess how the retreat experience impacts these markers of cellular aging and inflammation. The hypotheses are that retreat participation will increase both telomere length and telomerase activity, but decrease IL-6 levels. The investigators will also assess the impact of retreat participation on oxytocin-a hormone involved in a number of physiological and behavioral processes, including affiliative bonds and stress responses-the hypothesis being that participation in the retreat will increase plasma oxytocin levels. The investigators will then explore how these and other biomarkers relate to psychological processes and personality traits, which may also be altered by participation in the meditation retreat.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retreat | – | Other: Residential Insight Meditation RetreatParticipants registered for a one-month, residential Insight Meditation retreat held at Spirit Rock Meditation Center in either February or March, 2013 |
| Comparison | – | –Experienced meditators from the Spirit Rock Meditation Community |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults with meditation experience
Key inclusion criteria (1 listed)
- Previous meditation experience equivalent to two 5-10 day residential meditation retreats
Key exclusion criteria (1 listed)
- Disclosure of potentially contagious blood-borne illness (e.g., HIV, Hepatitis, etc.) or other illnesses that might interfere with telomere or telomerase measurement
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 |
|---|---|---|
| Residential Insight Meditation RetreatRetreats at Spirit Rock Meditation Center were led by teams of 6 experienced teachers. Participants practiced "noble silence"-refraining from eye contact as well as verbal and written communication-except during meetings with teachers. Teachers lead guided Insight meditation practices, as well as meditations on loving-kindness, compassion, empathetic joy, and equanimity. The daily schedule consisted of sitting and walking meditation sessions (30-45 mins) totaling 8-10 hours/day, meals, and short work meditations (sweeping, dishes, etc.). Seated meditation was practiced as a group in a meditation hall with approximately 80 participants. Walking meditation took place in adjoining halls or on the grounds. Participants lived on-site during the retreat and were provided with a vegetarian diet. | Other | Retreat |
Primary outcome
Telomerase
Time frame: change from the start of retreat to three weeks into the retreat period
an enzyme that repairs the shortening of telomeres that occurs during aging
Telomere length
Time frame: change from the start of retreat to three weeks into the retreat period
the repetitive sequence of DNA that serves as a protective cap to eukaryotic chromosomes, which protects from degradation and instability and is related to longevity
Interleukin-6
Time frame: change from the start of retreat to three weeks into the retreat period
a primary measure of inflammation, which is influenced by psychological stress
Oxytocin
Time frame: change from the start of retreat to three weeks into the retreat period
an affiliative hormone associated with social bonding in both men and women, and which downregulates inflammatory cytokines
16 secondary outcomes
Arginine Vasopressin
Time frame: two measurements, three weeks apart
Brain Derived Neurotrophic Factor
Time frame: two measurements, three weeks apart
pro- and anti-inflammatory cytokines (IL-1b, IL-2, IL-4, IL-5, IL-10, IL-12 (p70), IL-13, IFN-γ, TNF-α)
Time frame: two measurements, three weeks apart
State-Trait Anxiety Inventory
Time frame: two measurements, three weeks apart
Lifestyle Profile II
Time frame: two measurements, three weeks apart
Experience in Close Relationships, short form
Time frame: two measurements, three weeks apart
Mysticism Scale
Time frame: two measurements, three weeks apart
Non-attachment Scale
Time frame: two measurements, three weeks apart
Self-Assessed Wisdom Scale
Time frame: two measurements, three weeks apart
Ego Resiliency Scale
Time frame: two measurements, three weeks apart
Five Facet Mindfulness Questionnaire
Time frame: two measurements, three weeks apart
Center for Epidemiological Studies Depression Scale
Time frame: two measurements, three weeks apart
Psychological Wellbeing Scale
Time frame: two measurements, three weeks apart
Three Dimensional Wisdom Scale
Time frame: two measurements, three weeks
Big Five Inventory
Time frame: two measurements, three weeks
Difficulties in Emotion Regulation Scale
Time frame: two measurements, three 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 30 May 2017.
- Derived from this study: PubMed 29518528Conklin QA, King BG, Zanesco AP, Lin J, Hamidi AB, Pokorny JJ, Alvarez-Lopez MJ, Cosin-Tomas M, Huang C, Kaliman P, Epel ES, Saron CD. Insight meditation and telomere biology: The effects of intensive retreat and the moderating role of personality. Brain Behav Immun. 2018 May;70:233-245. doi: 10.1016/j.bbi.2018.03.003. Epub 2018 Mar 5.
- Individual participant dataSharing planned: Undecided
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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.
Clifford D Saron, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by University of California, Davis 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 1 inclusion and 1 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 30 May 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.
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 the start of retreat to three weeks into the retreat period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03056105, which also lists 1 linked publication.
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 30 May 2017.