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

NCT ID: NCT00636129

Last Updated: 2011-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-12-31

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Stress

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Relaxation Response + Stress Management Curriculum

Relaxation Response + Stress Management Curriculum

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Herbert Benson

Director Emeritus, Benson-Henry Institute for Mind Body Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Herbert Benson, MD

Role: PRINCIPAL_INVESTIGATOR

Benson-Henry Institute for Mind Body Medicine at Massachusetts General Hosptial

Locations

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Benson-Henry Institute for Mind Body Medicine

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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MIT COUHES 577

Identifier Type: -

Identifier Source: org_study_id

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