Does the Relaxation Response Inhibit Acute Stress? - Full Text View

Sponsors and Collaborators:	Beth Israel Deaconess Medical Center Centers for Disease Control and Prevention
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00179595

Purpose

The purposes of this study are:

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

Drug Information available for: Nitric oxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
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:

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

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

Centers for Disease Control and Prevention

Investigators

Principal Investigator:

Herbert Benson, MD

Beth Israel Deaconess Medical Center

More Information

Study ID Numbers:	2001-P-001747, H75-CCH-123424, H75-CCH-119124
Study First Received:	September 13, 2005
Last Updated:	October 30, 2007
ClinicalTrials.gov Identifier:	NCT00179595
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

Study placed in the following topic categories:

Nitric Oxide
Stress
Healthy

ClinicalTrials.gov processed this record on January 14, 2009