Does the Relaxation Response Inhibit Acute Stress? | NCT00179595

Studies
Does the Relaxation Response Inhibit Acute Stress?

NCT00179595

Sponsor

Beth Israel Deaconess Medical Center

Status

Completed

Last Update Posted

Feb 16, 2017Actual

Enrollment

140Estimated

Phase

Phase 2

Conditions

Healthy

Interventions

relaxation response- meditation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2002

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2017

Last Update Posted Date

Feb 16, 2017Actual

Name	Class
Centers for Disease Control and Prevention	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purposes of this study are:

To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.
To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.

Since stress is a factor in the development of many health conditions, a further understanding of the mechanisms of the RR should be developed. The project is designed to determine how the RR can improve the quality of life that has been adversely affected by stress.

Detailed Description

The purposes of this study are:

To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.
To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Name	Type	Description	Arm Group Labels	Other Names
relaxation response- meditation	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.

Secondary Outcomes

Measure	Description	Time Frame
To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy individual
age:18-49 years
able to read and understand English
able to attend al study visits
access to a telephone (to schedule visits)

Exclusion Criteria:

current smoking
asthma
current use of any prescription or psychoactive medications or supplements
either:
1. no prior experience with RR eliciting techniques
2. at least 3 years of regular RR elicitation (at least 20 min/day)
BMI >30
exhaled nitric oxide levels >60 ppb
abnormal lab values (Hct <32,creatinine >1.3, glucose >200
pregnancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Herbert Benson, MD	Beth Israel Deaconess Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beth-Israel Deaconess Medical Center		Boston	Massachusetts	02215	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Type	Description	Link
H75-CCH-123424
H75-CCH-119124