Biochemical and Physiological Changes Associated With Differing Durations of Relaxation Response Training
This study has been completed.
Sponsor:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00636129
First Posted: March 14, 2008
Last Update Posted: September 19, 2011
Information provided by (Responsible Party):
Herbert Benson, Massachusetts General Hospital
| Tracking Information | ||||
|---|---|---|---|---|
| First Submitted Date | March 7, 2008 | |||
| First Posted Date | March 14, 2008 | |||
| Last Update Posted Date | September 19, 2011 | |||
| Start Date | December 2006 | |||
| 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 | 30 | |||
| Completion Date | March 2011 | |||
| Primary Completion Date | March 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
|
|||
| Sex/Gender |
|
|||
| 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 |
|
|||
| PRS Account | Massachusetts General Hospital | |||
| Verification Date | September 2011 | |||