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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

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.

Condition or disease Intervention/treatment Phase
Stress Behavioral: RR Behavioral: MBSR Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Active Comparator: Program A - Relaxation Response (RR)
One of the 2 stress reduction courses
Behavioral: RR
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
Behavioral: MBSR
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 25 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

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

Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02119
Sponsors and Collaborators
Massachusetts General Hospital
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Sara Lazar, PhD Massachusetts General Hospital

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Responsible Party: Sara W Lazar, Associate Research Scientist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00625807     History of Changes
Other Study ID Numbers: R21AT003425-01A2 ( U.S. NIH Grant/Contract )
R21AT003425-01A2 ( U.S. NIH Grant/Contract )
SL1
First Posted: February 28, 2008    Key Record Dates
Results First Posted: August 7, 2018
Last Update Posted: August 7, 2018
Last Verified: July 2018

Keywords provided by Sara W Lazar, Massachusetts General Hospital:
Stress
meditation
stress reduction
fMRI
behavioral