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

Tracking Information
First Submitted Date	March 7, 2008
First Posted Date	March 14, 2008
Last Update Posted Date	September 19, 2011
Study Start Date	December 2006
Actual Primary Completion Date	March 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00636129 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Biochemical and Physiological Changes Associated With Differing Durations of Relaxation Response Training
Official Title	Biochemical and Physiological Changes Associated With Differing Durations of Relaxation Response Training
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).
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 Type	Observational
Study Design	Observational Model: Case-Only; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA; Description: Whole blood Serum Plasma
Sampling Method	Non-Probability Sample
Study Population	Healthy subjects ages 18-49.
Condition	Stress
Intervention	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.
Study Groups/Cohorts	1; Relaxation Response + Stress Management Curriculum; Intervention: Behavioral: Relaxation Response + Stress Management Curriculum
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Estimated Enrollment; (submitted: March 13, 2008)	30
Original Estimated Enrollment	Same as current
Actual Study Completion Date	March 2011
Actual Primary Completion Date	March 2011 (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 49 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00636129
Other Study ID Numbers	MIT COUHES 577
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Herbert Benson, Massachusetts General Hospital
Study Sponsor	Massachusetts General Hospital
Collaborators	Not Provided
Investigators	Principal Investigator: Herbert Benson, MD Benson-Henry Institute for Mind Body Medicine at Massachusetts General Hosptial
PRS Account	Massachusetts General Hospital
Verification Date	September 2011