Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

March 7, 2008
September 16, 2011
December 2006
March 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00636129 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Biochemical and Physiological Changes Associated With Differing Durations of Relaxation Response Training
Biochemical and Physiological Changes Associated With Differing Durations of Relaxation Response Training

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).

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood Serum Plasma

Non-Probability Sample

Healthy subjects ages 18-49.

Stress
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.
1
Relaxation Response + Stress Management Curriculum
Intervention: Behavioral: Relaxation Response + Stress Management Curriculum
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 49 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00636129
MIT COUHES 577
No
Herbert Benson, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Herbert Benson, MD Benson-Henry Institute for Mind Body Medicine at Massachusetts General Hosptial
Massachusetts General Hospital
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP