The Relaxation vs. Retreat Study

Stress Clinical Trial

— R&R  

Official title:

The Effect of a Short Term Meditation Retreat on Markers of Cellular Stress and Aging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857830
• Other study ID #: 12-1039
• Status: Completed
• Phase: N/A
• First received: April 25, 2013
• Last updated: August 19, 2013
• Start date: April 2013
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Ageing
• Stress
• Wellbeing

Intervention

Behavioral:
• Meditation Retreat
The intervention is a one week meditation and yoga retreat hosted at the La Costa Resort and Spa in Carlsbad, CA.
• Active Comparator Relaxation Group
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.

Locations

Country	Name	City	State
United States	Chopra Center for Wellbeing	Carlsbad	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline in Telomerase 96 hours later	No
Secondary	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.	Change from baseline in Amyloid Beta Proteins, 96 hours later	No
Secondary	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).	Change from Baseline in psychological well being at 96 hours, and 1 month later.	No
Secondary	Oxytocin	Plasma is saved from baseline and 96 hour followup for oxytocin assays.	Change from baseline in Oxytocin at 96 hours later.	No
Secondary	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.	Change from Baseline in Telomere Length, 96 hours later	No
Secondary	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.	Change from Baseline in Gene Expression, 96 hours later	No