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

Completed

• Conditions: Stress
• Interventions: Behavioral: Relaxation Response + Stress Management Curriculum

• Registration Number: NCT00636129
• Lead Sponsor: Massachusetts General Hospital

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 Timeline

• Study Start: 2006-12
• Study First Submitted: 2008-03-07
• Study First Submitted QC: 2008-03-13
• Study First Posted: 2008-03-14
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-16
• Last Update Posted: 2011-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Relaxation Response + Stress Management Curriculum	Relaxation Response + Stress Management Curriculum

Trial Locations

Locations (1)

Benson-Henry Institute for Mind Body Medicine; 🇺🇸 Boston, Massachusetts, United States