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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • California
      • Davis, California, United States, 95616
        • University of California, Davis

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Retreat
Participants registered for a one-month, residential Insight Meditation retreat held at Spirit Rock Meditation Center in either February or March, 2013
Other: Residential Insight Meditation Retreat
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.
Comparison
Experienced meditators from the Spirit Rock Meditation Community

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
change from the start of retreat to three weeks into the retreat period
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
change from the start of retreat to three weeks into the retreat period
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
change from the start of retreat to three weeks into the retreat period
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
change from the start of retreat to three weeks into the retreat period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Arginine Vasopressin
Time Frame: two measurements, three weeks apart
a less commonly studied affiliative hormone also associated with close social bonds
two measurements, three weeks apart
Brain Derived Neurotrophic Factor
Time Frame: two measurements, three weeks apart
a protein related to neuroplasticity, learning, and memory, which is decreased in depression
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
a family of proteins involved in generating and regulating the immune system
two measurements, three weeks apart
State-Trait Anxiety Inventory
Time Frame: two measurements, three weeks apart
10 item scale designed to assess trait-anxiety (STAI; Spielberger et al., 1983)
two measurements, three weeks apart
Lifestyle Profile II
Time Frame: two measurements, three weeks apart
Assesses health-promoting lifestyle factors (Walker et al., 1987)
two measurements, three weeks apart
Experience in Close Relationships, short form
Time Frame: two measurements, three weeks apart
Assesses attachment anxiety (fear of rejection or abandonment) and avoidance (avoidance of intimacy and interdependence) (ECR-12: Lafontaine et al., 2015)
two measurements, three weeks apart
Mysticism Scale
Time Frame: two measurements, three weeks apart
Assesses mystical experience and religious interpretation (M-Scale; Hood, 1975)
two measurements, three weeks apart
Non-attachment Scale
Time Frame: two measurements, three weeks apart
Assesses non-attachment from a Buddhist perspective (NAS; Sahdra, Shaver & Brown, 2010)
two measurements, three weeks apart
Self-Assessed Wisdom Scale
Time Frame: two measurements, three weeks apart
Assess five dimensions of wisdom: 1) Experience, 2) Emotional Regulation, 3) Reminiscence and Reflectiveness, 4) Openness, 5) Humor (SAWS; Webster, 2003)
two measurements, three weeks apart
Ego Resiliency Scale
Time Frame: two measurements, three weeks apart
Assesses the ability to adapt one's level of control temporarily up or down as circumstances dictate (EGO; Block & Kremen, 1996)
two measurements, three weeks apart
Five Facet Mindfulness Questionnaire
Time Frame: two measurements, three weeks apart
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)
two measurements, three weeks apart
Center for Epidemiological Studies Depression Scale
Time Frame: two measurements, three weeks apart
Assesses depressive symptomatology (CES-D; Radloff, 1977)
two measurements, three weeks apart
Psychological Wellbeing Scale
Time Frame: two measurements, three weeks apart
Assess autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance (PWBS; Ryff, 1989)
two measurements, three weeks apart
Three Dimensional Wisdom Scale
Time Frame: two measurements, three weeks
Assess three dimensions of wisdom: 1) Cognitive, 2) Reflective, and 3) Affective (3-DWS; Ardelt, 2003)
two measurements, three weeks
Big Five Inventory
Time Frame: two measurements, three weeks
Assesses extraversion, agreeableness, conscientiousness, openness to experience, neuroticism (BFI; Goldberg, 1993)
two measurements, three weeks
Difficulties in Emotion Regulation Scale
Time Frame: two measurements, three weeks
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)
two measurements, three weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gene Expression of genes relating to inflammation and telomere regulation
Time Frame: two measurements, three weeks
PBMC RNA for exploratory gene expression studies
two measurements, three weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Davis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of California, San Francisco
University of Barcelona

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 4, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 4, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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