Does the Relaxation Response Inhibit Acute Stress?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Beth Israel Deaconess Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00179595
First received: September 13, 2005
Last updated: October 30, 2007
Last verified: October 2007
  Purpose

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.


Condition Intervention Phase
Healthy
Behavioral: relaxation response- meditation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Does the Relaxation Response Inhibit Acute Stress?

Further study details as provided by Beth Israel Deaconess Medical Center:

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

Estimated Enrollment: 140
Study Start Date: May 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179595

Contacts
Contact: Jeffery A Dusek, PhD 617-991-0102 jdusek@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth-Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jeffery A Dusek, PhD    617-991-0201 ext 212    jdusek@bidmc.harvard.edu   
Principal Investigator: Herbert Benson, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Herbert Benson, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00179595     History of Changes
Other Study ID Numbers: 2001-P-001747, H75-CCH-123424, H75-CCH-119124
Study First Received: September 13, 2005
Last Updated: October 30, 2007
Health Authority: United States: Institutional Review Board
United States: Centers for Disease Control and Prevention
United States: Food and Drug Administration
United States: Department of Health and Human Services
United States: National Institutes of Health
United States: Office for Human Research Protections

Keywords provided by Beth Israel Deaconess Medical Center:
nitric oxide, volumetric oxygen consumption

ClinicalTrials.gov processed this record on August 28, 2014