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Biochemical and Physiological Changes Associated With Differing Durations of Relaxation Response Training
This study is currently recruiting participants.
Verified by Massachusetts General Hospital, March 2008
First Received: March 7, 2008   Last Updated: March 13, 2008   History of Changes
Sponsored by: Massachusetts General Hospital
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00636129
  Purpose

We are looking at the effects of Stress Management and Relaxation Response training on stress hormones (like adrenalin and cortisol), immune function and physiology (heart rate, breathing rate, muscle tension).


Condition Intervention
Stress
Behavioral: Relaxation Response + Stress Management Curriculum

U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Biochemical and Physiological Changes Associated With Differing Durations of Relaxation Response Training

Further study details as provided by Massachusetts General Hospital:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Whole blood Serum Plasma


Estimated Enrollment: 30
Study Start Date: December 2006
Groups/Cohorts Assigned Interventions
1
Relaxation Response + Stress Management Curriculum
Behavioral: Relaxation Response + Stress Management Curriculum
Subjects will receive 8 weeks of Stress Management curriculum and guidance through 20 minute Relaxation Response with a research coordinator. They will also practice 20 minutes of Relaxation Response at home daily.

Detailed Description:

The primary aim of this study is to determine whether differing durations of relaxation response (RR) training will be associated with different degrees of change in physiological, psychological, hormonal, molecular and immunological markers. Prior studies have reported reduction on many of these parameters after 8 weeks of RR training. However, we now seek to understand the degree to which incremental decreases in these parameters are exhibited at 0, 4, and 8 weeks of RR practice in 30 healthy adults. Furthermore, we will explore correlations between levels of exhaled nitric oxide or plasma nitrites/nitrates and oxygen consumption during RR elicitation. We will also examine any associations between changes in oxygen consumption and psychological factors, physiological parameters, and biochemical outcomes. Lastly, we will bank plasma and peripheral blood cells from these samples for future assessments of immune markers, cell typing and gene expression.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy subjects ages 18-49.

Criteria

Inclusion Criteria:

  • Age 18-49
  • Healthy subjects

Exclusion Criteria:

  • Taking medication
  • Asthma or allergies
  • Prior regular relaxation practice
  • Body Mass Index >39
  • Beck Depression Inventory (BDI) score indicates possible clinical depression
  • Current mental health treatment
  • Diagnosis of severe mental illness
  • Using hormonal birth control
  • Females: pregnant or trying to conceive
  • Exhaled Nitric Oxide (NO) levels > 60PPB
  • Hematocrit < 32%
  • Blood glucose < 50 or > 200
  • Creatinine > 1.3
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636129

Contacts
Contact: Megan M Foret 617-732-9747 bhiresearchstudies@partners.org

Locations
United States, Massachusetts
Benson-Henry Institute for Mind Body Medicine Recruiting
Chestnut Hill, Massachusetts, United States, 02467
Principal Investigator: Herbert Benson, MD            
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Herbert Benson, MD Benson-Henry Institute for Mind Body Medicine at Massachusetts General Hosptial
  More Information

Additional Information:
No publications provided

Responsible Party: The Benson-Henry Institute for Mind Body Medicine ( Dr. Herbert Benson, MD )
Study ID Numbers: MIT COUHES 577
Study First Received: March 7, 2008
Last Updated: March 13, 2008
ClinicalTrials.gov Identifier: NCT00636129     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
relaxation
relaxation response
meditation
nitric oxide
stress management
stress
Relaxation Techniques

Study placed in the following topic categories:
Nitric Oxide
Stress

ClinicalTrials.gov processed this record on May 07, 2009