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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

Tracking Information
First Submitted Date  ICMJE February 26, 2008
First Posted Date  ICMJE February 28, 2008
Results First Submitted Date  ICMJE December 10, 2017
Results First Posted Date  ICMJE August 7, 2018
Last Update Posted Date August 7, 2018
Study Start Date  ICMJE January 2008
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 26, 2008)
Brain activity (fMRI) [ Time Frame: Pre, post ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2008)
  • Physical and psychological well-being [ Time Frame: Pre, post, 3-months post ]
  • Emotion processing [ Time Frame: Pre, post ]
  • Attention [ Time Frame: Pre, post ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Behavioral Treatments for Stress Reduction
Official Title  ICMJE Exploratory Analysis of the Relaxation Response (RR) and Mindfulness Based Stress Reduction (MBSR) for Stress Reduction
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Stress
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Program A - Relaxation Response (RR)
    One of the 2 stress reduction courses
    Intervention: Behavioral: RR
  • Active Comparator: Program B - Mindfullness-based stress reduction (MBSR)
    One of the 2 stress reduction courses
    Intervention: Behavioral: MBSR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2018)
50
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2008)
60
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00625807
Other Study ID Numbers  ICMJE R21AT003425-01A2( U.S. NIH Grant/Contract )
R21AT003425-01A2 ( U.S. NIH Grant/Contract )
SL1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sara W Lazar, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Sara Lazar, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP