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

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636129
• Other study ID #: MIT COUHES 577
• Status: Completed
• Phase: N/A
• First received: March 7, 2008
• Last updated: September 16, 2011
• Start date: December 2006
• Est. completion date: March 2011

Study information

• Verified date: September 2011
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
United States	Benson-Henry Institute for Mind Body Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

External Links

•   Benson Henry Institute Home Page