Comparison of Two Behavioral Treatments for Stress Reduction

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00625807
First received: February 26, 2008
Last updated: December 3, 2009
Last verified: December 2009
  Purpose

Currently there are 2 popular stress reduction courses that are widely used in the US. Although they use somewhat similar techniques, it is currently unknown whether or not they work the same way, or if they are similarly effective at reducing stress. The study will directly compare these 2 courses. Participants will undergo approximately 4-5 hours of testing before and after each 8-week course.


Condition Intervention Phase
Stress
Behavioral: RR
Behavioral: MBSR
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Exploratory Analysis of RR and MBSR for Stress Reduction

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Brain activity (fMRI) [ Time Frame: Pre, post ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical and psychological well-being [ Time Frame: Pre, post, 3-months post ] [ Designated as safety issue: No ]
  • Emotion processing [ Time Frame: Pre, post ] [ Designated as safety issue: No ]
  • Attention [ Time Frame: Pre, post ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: January 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RR
One of the 2 stress reduction courses
Behavioral: RR
A well-validated 8 week stress reduction course. Classes meet once a week from 5-8:30 PM. Participants will be asked to perform stress reduction techniques each night for 25 minutes throughout the entire 8-week course
Active Comparator: MBSR
One of the 2 stress reduction courses
Behavioral: MBSR
A well-validated 8 week stress reduction course. Classes meet once a week from 5-8:30 PM. Participants will be asked to perform stress reduction techniques each night for 25 minutes throughout the entire 8-week course

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 25 to 55 years old
  • Good general health
  • Able to attend all 8 sessions of the course and practice the techniques each night for 25 minutes

Exclusion Criteria:

  • Psychiatric medications
  • Significant medical or psychological illness
  • Metalic implants (such as a pacemaker or artificial joints) that are not MRI compatible.
  • Claustrophobia
  • Pregnancy
  • Previous head trauma or neurological disorder
  • Previous experience with yoga or meditation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00625807

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02119
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Sara Lazar, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Sara Lazar, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00625807     History of Changes
Other Study ID Numbers: R21 AT003425-01A2, R21AT003425-01A2, SL1
Study First Received: February 26, 2008
Last Updated: December 3, 2009
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Stress
meditation
stress reduction
fMRI
behavioral

ClinicalTrials.gov processed this record on April 16, 2014