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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Herbert Benson, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00636129
First received: March 7, 2008
Last updated: September 16, 2011
Last verified: September 2011
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: 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

Whole blood Serum Plasma


Estimated Enrollment: 30
Study Start Date: December 2006
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
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
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: 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

No publications provided

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
Study First Received: March 7, 2008
Last Updated: September 16, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014