- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03056105
The Psychobiological Effects of Participation in a One-Month Insight Meditation Retreat
May 24, 2017 updated by: University of California, Davis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
66
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Davis, California, United States, 95616
- University of California, Davis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy adults with meditation experience
Description
Inclusion Criteria:
- Previous meditation experience equivalent to two 5-10 day residential meditation retreats
Exclusion Criteria:
- Disclosure of potentially contagious blood-borne illness (e.g., HIV, Hepatitis, etc.) or other illnesses that might interfere with telomere or telomerase measurement
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Retreat
Participants registered for a one-month, residential Insight Meditation retreat held at Spirit Rock Meditation Center in either February or March, 2013
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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.
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Comparison
Experienced meditators from the Spirit Rock Meditation Community
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Telomerase
Time Frame: change from the start of retreat to three weeks into the retreat period
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an enzyme that repairs the shortening of telomeres that occurs during aging
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change from the start of retreat to three weeks into the retreat period
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Telomere length
Time Frame: change from the start of retreat to three weeks into the retreat period
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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
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change from the start of retreat to three weeks into the retreat period
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Interleukin-6
Time Frame: change from the start of retreat to three weeks into the retreat period
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a primary measure of inflammation, which is influenced by psychological stress
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change from the start of retreat to three weeks into the retreat period
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Oxytocin
Time Frame: change from the start of retreat to three weeks into the retreat period
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an affiliative hormone associated with social bonding in both men and women, and which downregulates inflammatory cytokines
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change from the start of retreat to three weeks into the retreat period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arginine Vasopressin
Time Frame: two measurements, three weeks apart
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a less commonly studied affiliative hormone also associated with close social bonds
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two measurements, three weeks apart
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Brain Derived Neurotrophic Factor
Time Frame: two measurements, three weeks apart
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a protein related to neuroplasticity, learning, and memory, which is decreased in depression
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two measurements, three weeks apart
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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
|
a family of proteins involved in generating and regulating the immune system
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two measurements, three weeks apart
|
State-Trait Anxiety Inventory
Time Frame: two measurements, three weeks apart
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10 item scale designed to assess trait-anxiety (STAI; Spielberger et al., 1983)
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two measurements, three weeks apart
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Lifestyle Profile II
Time Frame: two measurements, three weeks apart
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Assesses health-promoting lifestyle factors (Walker et al., 1987)
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two measurements, three weeks apart
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Experience in Close Relationships, short form
Time Frame: two measurements, three weeks apart
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Assesses attachment anxiety (fear of rejection or abandonment) and avoidance (avoidance of intimacy and interdependence) (ECR-12: Lafontaine et al., 2015)
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two measurements, three weeks apart
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Mysticism Scale
Time Frame: two measurements, three weeks apart
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Assesses mystical experience and religious interpretation (M-Scale; Hood, 1975)
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two measurements, three weeks apart
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Non-attachment Scale
Time Frame: two measurements, three weeks apart
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Assesses non-attachment from a Buddhist perspective (NAS; Sahdra, Shaver & Brown, 2010)
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two measurements, three weeks apart
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Self-Assessed Wisdom Scale
Time Frame: two measurements, three weeks apart
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Assess five dimensions of wisdom: 1) Experience, 2) Emotional Regulation, 3) Reminiscence and Reflectiveness, 4) Openness, 5) Humor (SAWS; Webster, 2003)
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two measurements, three weeks apart
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Ego Resiliency Scale
Time Frame: two measurements, three weeks apart
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Assesses the ability to adapt one's level of control temporarily up or down as circumstances dictate (EGO; Block & Kremen, 1996)
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two measurements, three weeks apart
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Five Facet Mindfulness Questionnaire
Time Frame: two measurements, three weeks apart
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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)
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two measurements, three weeks apart
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Center for Epidemiological Studies Depression Scale
Time Frame: two measurements, three weeks apart
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Assesses depressive symptomatology (CES-D; Radloff, 1977)
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two measurements, three weeks apart
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Psychological Wellbeing Scale
Time Frame: two measurements, three weeks apart
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Assess autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance (PWBS; Ryff, 1989)
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two measurements, three weeks apart
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Three Dimensional Wisdom Scale
Time Frame: two measurements, three weeks
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Assess three dimensions of wisdom: 1) Cognitive, 2) Reflective, and 3) Affective (3-DWS; Ardelt, 2003)
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two measurements, three weeks
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Big Five Inventory
Time Frame: two measurements, three weeks
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Assesses extraversion, agreeableness, conscientiousness, openness to experience, neuroticism (BFI; Goldberg, 1993)
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two measurements, three weeks
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Difficulties in Emotion Regulation Scale
Time Frame: two measurements, three weeks
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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)
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two measurements, three weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gene Expression of genes relating to inflammation and telomere regulation
Time Frame: two measurements, three weeks
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PBMC RNA for exploratory gene expression studies
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two measurements, three weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Clifford D Saron, PhD, University of California, Davis
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 3, 2013
Primary Completion (Actual)
February 4, 2014
Study Completion (Actual)
February 4, 2014
Study Registration Dates
First Submitted
February 10, 2017
First Submitted That Met QC Criteria
February 16, 2017
First Posted (Actual)
February 17, 2017
Study Record Updates
Last Update Posted (Actual)
May 30, 2017
Last Update Submitted That Met QC Criteria
May 24, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 230734
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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