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Mindfulness-Based Meditation to Treat Stress in Unemployed Community Adults

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
David Creswell, Carnegie Mellon University
ClinicalTrials.gov Identifier:
NCT01628809
First received: June 20, 2012
Last updated: June 25, 2012
Last verified: June 2012

June 20, 2012
June 25, 2012
January 2011
October 2012   (final data collection date for primary outcome measure)
Functional Neural Activity [ Time Frame: Change from randomization to 1 week ] [ Designated as safety issue: No ]
Neural response to emotionally evocative stimuli including stressors related to be unemployed
Same as current
Complete list of historical versions of study NCT01628809 on ClinicalTrials.gov Archive Site
  • Brain volume [ Time Frame: Change from randomization to 1 week ] [ Designated as safety issue: No ]
    Change in volume of brain areas associated with emotional reactivity
  • Pro-inflammation [ Time Frame: from baseline to four-month follow-up ] [ Designated as safety issue: No ]
    Change in protein measures of inflammation
  • Psychological Distress [ Time Frame: baseline to four month follow-up ] [ Designated as safety issue: No ]
    self-reported psychological distress
  • Cortisol Levels [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Levels of cortisol were assessed from a small sample of participants' hair
Same as current
Not Provided
Not Provided
 
Mindfulness-Based Meditation to Treat Stress in Unemployed Community Adults
Stress Reduction and Healthy Living in Pittsburgh

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Stress
  • Inflammation
Behavioral: Mindfulness-Based Stress Reduction
three-day mindfulness-based meditation retreat program
Other Name: MBSR
  • Active Comparator: Rest and Relaxation
    three-day relaxation retreat without mindfulness components
    Intervention: Behavioral: Mindfulness-Based Stress Reduction
  • Experimental: Mindfulness-Based Meditation
    three-day mindfulness-based meditation retreat
    Intervention: Behavioral: Mindfulness-Based Stress Reduction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
35
December 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
24 Years to 52 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01628809
HLS-2011
No
David Creswell, Carnegie Mellon University
Carnegie Mellon University
Not Provided
Principal Investigator: J. David Creswell, PhD Carnegie Mellon University
Carnegie Mellon University
June 2012

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