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Completed

NCT Number: NCT01628809

Mindfulness-Based Meditation to Treat Stress in Unemployed Community Adults

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.

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Key information

Age range

24 year–52 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Stress Reduction

Behavioral

three-day mindfulness-based meditation retreat program

Other names: MBSR

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Carnegie Mellon University

Other

Registry information

Official study title

Stress Reduction and Healthy Living in Pittsburgh

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 27, 2012
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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