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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 7, 2008

Last Updated Date

September 16, 2011

Start Date ^ICMJE

December 2006

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00636129 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

Stress

Intervention ^ICMJE

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 Group/Cohort (s)

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 ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

March 2011

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 49 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00636129

Other Study ID Numbers ^ICMJE

MIT COUHES 577

Has Data Monitoring Committee

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Herbert Benson, Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Herbert Benson, MD

Benson-Henry Institute for Mind Body Medicine at Massachusetts General Hosptial

Information Provided By

Massachusetts General Hospital

Verification Date

September 2011

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

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