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Comparison of Two Behavioral Treatments for Stress Reduction

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ClinicalTrials.gov Identifier: NCT00625807
Recruitment Status : Completed
First Posted : February 28, 2008
Results First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Sara W Lazar, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Stress
Interventions Behavioral: RR
Behavioral: MBSR
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Relaxation Response (RR) Mindfulness Based Stress Reduction (MBSR)
Hide Arm/Group Description

One of the 2 stress reduction courses

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

One of the 2 stress reduction courses

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

Period Title: Overall Study
Started 22 28
Completed 20 20
Not Completed 2 8
Reason Not Completed
schedule conflict             2             8
Arm/Group Title Relaxation Response MBSR Total
Hide Arm/Group Description

One of the 2 stress reduction courses

Relaxation Response: A well-validated 8 week stress reduction course. Participants will be asked to perform stress reduction techniques from the Relaxation Response Program each night for 20 minutes throughout the entire 8-week course

One of the 2 stress reduction courses

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 from the MBSR program each night for 20 minutes throughout the entire 8-week course

Total of all reporting groups
Overall Number of Baseline Participants 22 28 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 28 participants 50 participants
39  (8.7) 37  (4.7) 37.9  (6.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 28 participants 50 participants
Female
15
  68.2%
18
  64.3%
33
  66.0%
Male
7
  31.8%
10
  35.7%
17
  34.0%
1.Primary Outcome
Title Brain Activity (fMRI) During the Body Scan Meditation
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Relaxation Response (RR) Mindfulness Based Stress Reduction (MBSR)
Hide Arm/Group Description:

One of the 2 stress reduction courses

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

One of the 2 stress reduction courses

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

Overall Number of Participants Analyzed 16 18
Measure Type: Number
Unit of Measure: voxels
74 82
2.Primary Outcome
Title Five Facet Mindfulness Questionnaire
Hide Description 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.
Time Frame Pre, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Individuals who completed at least one measure at post
Arm/Group Title Relaxation Response MBSR
Hide Arm/Group Description:

One of the 2 stress reduction courses

A well-validated 8 week stress reduction course. Participants were asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Meditation techniques focused on developing relaxation

One of the 2 stress reduction courses

A well-validated 8 week stress reduction course. Participants were asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Meditation techniques focused on developing mindfulness

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre 130.8  (17.7) 125.3  (17.7)
week 8 144.2  (20.6) 139.1  (21.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relaxation Response, MBSR
Comments ANOVA for group by time interaction
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value > 0.1
Comments Cohen's d = 0.5
Method ANOVA
Comments [Not Specified]
3.Primary Outcome
Title Perceived Stress Scale
Hide Description 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
Time Frame Pre, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Individuals who completed at least one measure at post
Arm/Group Title Relaxation Response MBSR
Hide Arm/Group Description:

One of the 2 stress reduction courses

A well-validated 8 week stress reduction course. Participants were asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Meditation techniques focused on developing relaxation

One of the 2 stress reduction courses

A well-validated 8 week stress reduction course. Participants were asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Meditation techniques focused on developing mindfulness

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre 14.1  (6.6) 18.4  (6.7)
week 8 11.3  (5.5) 12.3  (5.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relaxation Response, MBSR
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.103
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Primary Outcome
Title Penn State Worry Questionnaire
Hide Description 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.
Time Frame Pre, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Individuals who completed at least one measure at post
Arm/Group Title Relaxation Response MBSR
Hide Arm/Group Description:

One of the 2 stress reduction courses

A well-validated 8 week stress reduction course. Participants were asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Meditation techniques focused on developing relaxation

One of the 2 stress reduction courses

A well-validated 8 week stress reduction course. Participants were asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Meditation techniques focused on developing mindfulness

Overall Number of Participants Analyzed 19 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre 42.6  (11.9) 50.5  (13.1)
week 8 37.7  (10.1) 44.3  (12.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relaxation Response
Comments within group change pre to week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .022
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MBSR
Comments [Not Specified]
Type of Statistical Test Other
Comments within group change from pre to week 8
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Primary Outcome
Title Anxiety Severity Index
Hide Description 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.
Time Frame Pre, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Individuals who completed at least one measure at post
Arm/Group Title Relaxation Response MBSR
Hide Arm/Group Description:

One of the 2 stress reduction courses

A well-validated 8 week stress reduction course. Participants were asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Meditation techniques focused on developing relaxation

One of the 2 stress reduction courses

A well-validated 8 week stress reduction course. Participants were asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Meditation techniques focused on developing mindfulness

Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre 29.8  (7.3) 31.9  (9.4)
week 8 25.4  (5.7) 30.9  (8.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relaxation Response
Comments within group change from pre to week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .015
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MBSR
Comments within group change from pre to week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .53
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Self Compassion
Hide Description This scale assesses one's ability to be forgiving and kind to oneself in difficult circumstances. Scores range from 1-5. Higher scores mean more self compassion.
Time Frame Pre, week 8
Hide Outcome Measure Data
Hide Analysis Population Description
individuals who completed the measure at week 8
Arm/Group Title Relaxation Response MBSR
Hide Arm/Group Description:

One of the 2 stress reduction courses

A well-validated 8 week stress reduction course. Participants were asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Meditation techniques focused on developing relaxation

One of the 2 stress reduction courses

A well-validated 8 week stress reduction course. Participants were asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Meditation techniques focused on developing mindfulness

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
pre 2.9  (.67) 3.1  (.6)
week 8 3.2  (.72) 3.6  (.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relaxation Response
Comments within group change from pre to week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .06
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MBSR
Comments within group change from pre to post
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 2 months
Adverse Event Reporting Description Participants were given a daily log in which to record their daily meditation practice, overall stress levels, and any information about their practice or unusual occurances that they wished to share with the study team. Any individual who missed a class or dropped out of the study were contacted to determine the reason.
 
Arm/Group Title Relaxation Response MBSR
Hide Arm/Group Description

One of the 2 stress reduction courses

Program A: 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 20 minutes throughout the entire 8-week course

One of the 2 stress reduction courses

Program B: 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 20 minutes throughout the entire 8-week course

All-Cause Mortality
Relaxation Response MBSR
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/28 (0.00%) 
Hide Serious Adverse Events
Relaxation Response MBSR
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/28 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Relaxation Response MBSR
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/28 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sara Lazar
Organization: Massachusetts General Hospital
Phone: 617-724-2256
EMail: slazar@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Sara W Lazar, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00625807    
Other Study ID Numbers: R21AT003425-01A2 ( U.S. NIH Grant/Contract )
R21AT003425-01A2 ( U.S. NIH Grant/Contract )
SL1
First Submitted: February 26, 2008
First Posted: February 28, 2008
Results First Submitted: December 10, 2017
Results First Posted: August 7, 2018
Last Update Posted: August 7, 2018