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
  Purpose

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 Intervention
Stress
Inflammation
Behavioral: Mindfulness-Based Stress Reduction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Stress Reduction and Healthy Living in Pittsburgh

Further study details as provided by Carnegie Mellon University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 35
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   24 Years to 52 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01628809

Sponsors and Collaborators
Carnegie Mellon University
Investigators
Principal Investigator: J. David Creswell, PhD Carnegie Mellon University
  More Information

No publications provided

Responsible Party: David Creswell, Dr. J. David Creswell, Carnegie Mellon University
ClinicalTrials.gov Identifier: NCT01628809     History of Changes
Other Study ID Numbers: HLS-2011
Study First Received: June 20, 2012
Last Updated: June 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Carnegie Mellon University:
MBSR
mindfulness
stress

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014