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Biochemical and Physiological Changes Associated With Differing Durations of Relaxation Response Training

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ClinicalTrials.gov Identifier: NCT00636129
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : September 19, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Stress Behavioral: Relaxation Response + Stress Management Curriculum

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.

Study Design

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Biochemical and Physiological Changes Associated With Differing Durations of Relaxation Response Training
Study Start Date : December 2006
Primary Completion Date : March 2011
Study Completion Date : March 2011
Groups and Cohorts

Group/Cohort Intervention/treatment
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.


Outcome Measures

Biospecimen Retention:   Samples With DNA
Whole blood Serum Plasma

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636129


Locations
United States, Massachusetts
Benson-Henry Institute for Mind Body Medicine
Boston, Massachusetts, United States, 02114
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:
Responsible Party: Herbert Benson, Director Emeritus, Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00636129     History of Changes
Other Study ID Numbers: MIT COUHES 577
First Posted: March 14, 2008    Key Record Dates
Last Update Posted: September 19, 2011
Last Verified: September 2011

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