NCT00636129

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

September 19, 2011

Status Verified

September 1, 2011

Enrollment Period

4.2 years

First QC Date

March 7, 2008

Last Update Submit

September 16, 2011

Conditions

Stress

Keywords

relaxationrelaxation responsemeditationnitric oxidestress managementstressRelaxation Techniques

Study Arms (1)

1

Relaxation Response + Stress Management Curriculum

Behavioral: Relaxation Response + Stress Management Curriculum

Interventions

Relaxation Response + Stress Management CurriculumBEHAVIORAL

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.

1

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy subjects ages 18-49.

You may qualify if:

  • Age 18-49
  • Healthy subjects

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benson-Henry Institute for Mind Body Medicine

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood Serum Plasma

Study Officials

  • Herbert Benson, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Emeritus, Benson-Henry Institute for Mind Body Medicine

Study Record Dates

First Submitted

March 7, 2008

First Posted

March 14, 2008

Study Start

December 1, 2006

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

September 19, 2011

Record last verified: 2011-09

Locations

US(1)