IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Biochemical and Physiological Changes Associated With Differing Durations of Relaxation Response Training
This study has been completed.
Sponsor:
Massachusetts General Hospital
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
| 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 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 ICMJE | Completed | |||
| Estimated Enrollment ICMJE | 30 | |||
| Completion Date | March 2011 | |||
| Primary Completion Date | March 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
| Sex/Gender |
|
|||
| 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 | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| 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 |
|
|||
| PRS Account | 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 |
||||