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
|Condition or disease||Intervention/treatment||Phase|
|Stress||Behavioral: RR Behavioral: MBSR||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Exploratory Analysis of the Relaxation Response (RR) and Mindfulness Based Stress Reduction (MBSR) for Stress Reduction|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
Active Comparator: Program A - Relaxation Response (RR)
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
Active Comparator: Program B - Mindfullness-based stress reduction (MBSR)
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
- Brain Activity (fMRI) During the Body Scan Meditation [ Time Frame: Week 8 ]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.
- Five Facet Mindfulness Questionnaire [ Time Frame: Pre, 8 weeks ]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.
- Perceived Stress Scale [ Time Frame: Pre, 8 weeks ]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
- Penn State Worry Questionnaire [ Time Frame: Pre, 8 weeks ]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.
- Anxiety Severity Index [ Time Frame: Pre, 8 weeks ]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.
- Self Compassion [ Time Frame: Pre, week 8 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625807
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02119|
|Principal Investigator:||Sara Lazar, PhD||Massachusetts General Hospital|