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OpenTrials
Completed

NCT Number: NCT00636129

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

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).

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Key information

Conditions

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Benson-Henry Institute for Mind Body Medicine

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Relaxation Response + Stress Management Curriculum

Behavioral

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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Mar 14, 2008
Registry last updated
Sep 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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