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Mindfulness-Based Meditation to Treat Stress in Unemployed Community Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01628809
Recruitment Status : Completed
First Posted : June 27, 2012
Last Update Posted : July 28, 2015
Information provided by (Responsible Party):
David Creswell, Carnegie Mellon University

Brief Summary:
The purpose of this study is to determine the effects of a three-day mindfulness meditation retreat (vs. a three-day relaxation retreat) in stressed, unemployed, community adults on brain function, brain structure, and overall health and immunity.

Condition or disease Intervention/treatment Phase
Stress Inflammation Behavioral: Mindfulness-Based Stress Reduction Not Applicable

Detailed Description:

Chronic stress has been shown to be a significant risk factor for increased morbidity and mortality. Eight-week Mindfulness-Based Meditation programs (MBSR) have been shown to improve participants' health and well-being, including reducing inflammation and slowing the progression of chronic diseases such as HIV. The purpose of this study is to evaluate the potential benefits of a three-day mindfulness-based meditation retreat program (vs. an active rest and relaxation retreat control condition) on a highly stressed, unemployed, community adult population.

Participants are recruited from the Pittsburgh area and are randomly assigned to either the mindfulness-based retreat program or the rest and relaxation retreat program. All participants complete a psychosocial survey, blood work, and a baseline fMRI before completing the intervention. Participants complete a second fMRI immediately following the intervention and then additional blood work and psychosocial surveys at a four month follow-up timepoint. At each fMRI appointment, participants will complete neuroimaging tasks (where they will be presented with words, picture, and sounds) that will assess neuroreactivity, regulation responses, and brain volume before and after mindfulness meditation training.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Stress Reduction and Healthy Living in Pittsburgh
Study Start Date : January 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Active Comparator: Rest and Relaxation
three-day relaxation retreat without mindfulness components
Behavioral: Mindfulness-Based Stress Reduction
three-day mindfulness-based meditation retreat program
Other Name: MBSR

Experimental: Mindfulness-Based Meditation
three-day mindfulness-based meditation retreat
Behavioral: Mindfulness-Based Stress Reduction
three-day mindfulness-based meditation retreat program
Other Name: MBSR

Primary Outcome Measures :
  1. Functional Neural Activity [ Time Frame: Change from randomization to 1 week ]
    Neural response to emotionally evocative stimuli including stressors related to be unemployed

Secondary Outcome Measures :
  1. Brain volume [ Time Frame: Change from randomization to 1 week ]
    Change in volume of brain areas associated with emotional reactivity

  2. Pro-inflammation [ Time Frame: from baseline to four-month follow-up ]
    Change in protein measures of inflammation

  3. Psychological Distress [ Time Frame: baseline to four month follow-up ]
    self-reported psychological distress

  4. Cortisol Levels [ Time Frame: 1 day ]
    Levels of cortisol were assessed from a small sample of participants' hair

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   24 Years to 52 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • English-speaking adults between the ages of 24 and 52 years at time of entry
  • non-pregnant women only
  • currently unemployed
  • high levels of self-reported stress
  • geographically accessible and willing to travel to and attend all study sessions

Exclusion Criteria:

  • not able to attend scheduled three-day retreat
  • have regularly (>1 time per week) practiced a mind-body therapy anytime in the last six months (e.g., meditation, yoga, tai chi)
  • indicate any major physical health problems in the last six months
  • have more than 15 alcoholic drinks in the average week
  • have been diagnosed with a chronic disease (e.g. HIV, diabetes, arthritis)
  • use medications affecting cardiovascular or endocrine function
  • are left-handed
  • have metal in their bodies (including pacemakers and permanent piercings (e.g., bellyrings, but not dental fillings))
  • indicate regular use of psychotropic medication or psychotherapy in the last six months
  • cognitive impairment as indicated by a score lower than 23 on the Mini-Mental State examination
  • demonstrate low levels of stress due to unemployment
  • smokers
  • indicate use of recreational drugs in the past month
  • indicate feeling claustrophobic in confined spaces, such as an fMRI scanner
  • weigh over 350 lbs
  • have any neurological disorders
  • indicate any use of doctor prescribed cholesterol lowering medications (e.g., statins)
  • currently employed
  • not currently looking for a job

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 identifier (NCT number): NCT01628809

Sponsors and Collaborators
Carnegie Mellon University
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Principal Investigator: J. David Creswell, PhD Carnegie Mellon University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: David Creswell, Dr. J. David Creswell, Carnegie Mellon University Identifier: NCT01628809    
Other Study ID Numbers: HLS-2011
First Posted: June 27, 2012    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015
Keywords provided by David Creswell, Carnegie Mellon University:
Additional relevant MeSH terms:
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Pathologic Processes