Does the Relaxation Response Inhibit Acute Stress?

The purposes of this study are:

1. To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.
2. To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.

Since stress is a factor in the development of many health conditions, a further understanding of the mechanisms of the RR should be developed. The project is designed to determine how the RR can improve the quality of life that has been adversely affected by stress.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Behavioral: relaxation response- meditation

Detailed Description

The purposes of this study are:

1. To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.
2. To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.

Since stress is a factor in the development of many health conditions, a further understanding of the mechanisms of the RR should be developed. The project is designed to determine how the RR can improve the quality of life that has been adversely affected by stress.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth-Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy individual
• age:18-49 years
• able to read and understand English
• able to attend al study visits
• access to a telephone (to schedule visits)

Exclusion Criteria:

• current smoking
• asthma
• current use of any prescription or psychoactive medications or supplements

• either:

  1. no prior experience with RR eliciting techniques
  2. at least 3 years of regular RR elicitation (at least 20 min/day)
• BMI >30
• exhaled nitric oxide levels >60 ppb
• abnormal lab values (Hct <32,creatinine >1.3, glucose >200
• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.

Secondary Outcome Measures

Outcome Measure
To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Herbert Benson, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2002
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Actual): February 16, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: nitric oxide, volumetric oxygen consumption
• Other Study ID Numbers: 2001P001747; H75-CCH-123424; H75-CCH-119124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO