Comparison of Two Behavioral Treatments for Stress Reduction
Exploratory Analysis of the Relaxation Response (RR) and Mindfulness Based Stress Reduction (MBSR) for Stress Reduction
2 other identifiers
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 26, 2008
CompletedFirst Posted
Study publicly available on registry
February 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
August 7, 2018
CompletedAugust 7, 2018
July 1, 2018
1.8 years
February 26, 2008
December 10, 2017
July 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Brain Activity (fMRI) During the Body Scan Meditation
Seed based functional connectivity analysis was performed using the Connectivity Toolbox (CONN) implemented within the Statistical Parametric Mapping program (SPM8; Welcome Department of Cognitive Neurology). Our seeds were located in the right inferior frontal gyrus pars opercularis (MNI coordinates: 54, 14, 16) and the dorsal anterior insula (MNI coordinates: 32, 20, 0). Note - MRI data from some subjects was either missing, not collected, or corrupted, and so the analyses were performed on just the subject of subjects who had complete datasets. This assessment reflects the total number of voxels per group.
Week 8
Five Facet Mindfulness Questionnaire
The Five Facet Mindfulness Questionnaire (FFMQ) has been developed as a reliable and valid comprehensive instrument for assessing different aspects of mindfulness in community samples. Scores range from 39-195 with higher scores meaning more mindfulness.
Pre, 8 weeks
Perceived Stress Scale
The PSS is brief, validated and widely used psychological instrument for assessing a subject's perception of stress change. Scores range from 0-40 with higher scores meaning more stress
Pre, 8 weeks
Penn State Worry Questionnaire
The Penn State Worry Questionnaire (PSWQ) is a standard self-report questionnaire that is designed to assess symptoms of General Anxiety Disorder. scores range from 16-80 with higher scores meaning more stress.
Pre, 8 weeks
Anxiety Severity Index
the Anxiety Sensitivity Index (ASI) is a measure of individuals discomfort with a variety of sensations associated with anxiety and panic and tends to be substantially higher in those with panic disorder (and attacks) than in those with General Anxiety Disorder. Scores range from 0 - 64. Lower scores mean lower anxiety.
Pre, 8 weeks
Secondary Outcomes (1)
Self Compassion
Pre, week 8
Study Arms (2)
Program A - Relaxation Response (RR)
ACTIVE COMPARATOROne of the 2 stress reduction courses
Program B - Mindfullness-based stress reduction (MBSR)
ACTIVE COMPARATOROne of the 2 stress reduction courses
Interventions
A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing relaxation
A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing mindfulness
Eligibility Criteria
You may qualify if:
- to 60 years old
- Good general health
- Able to attend all 8 sessions of the course and practice the techniques each night for 25 minutes
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02119, United States
MeSH Terms
Conditions
Results Point of Contact
- Title
- Sara Lazar
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Sara Lazar, PhD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Research Scientist
Study Record Dates
First Submitted
February 26, 2008
First Posted
February 28, 2008
Study Start
January 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
August 7, 2018
Results First Posted
August 7, 2018
Record last verified: 2018-07