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Mindfulness-Based Meditation to Treat Stress in Unemployed Community Adults

Primary Purpose

Stress, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness-Based Stress Reduction
Sponsored by
Carnegie Mellon University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress focused on measuring MBSR, mindfulness, stress

Eligibility Criteria

24 Years - 52 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Rest and Relaxation

    Mindfulness-Based Meditation

    Arm Description

    three-day relaxation retreat without mindfulness components

    three-day mindfulness-based meditation retreat

    Outcomes

    Primary Outcome Measures

    Functional Neural Activity
    Neural response to emotionally evocative stimuli including stressors related to be unemployed

    Secondary Outcome Measures

    Brain volume
    Change in volume of brain areas associated with emotional reactivity
    Pro-inflammation
    Change in protein measures of inflammation
    Psychological Distress
    self-reported psychological distress
    Cortisol Levels
    Levels of cortisol were assessed from a small sample of participants' hair

    Full Information

    First Posted
    June 20, 2012
    Last Updated
    July 27, 2015
    Sponsor
    Carnegie Mellon University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01628809
    Brief Title
    Mindfulness-Based Meditation to Treat Stress in Unemployed Community Adults
    Official Title
    Stress Reduction and Healthy Living in Pittsburgh
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    October 2012 (Actual)
    Study Completion Date
    December 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Carnegie Mellon University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress, Inflammation
    Keywords
    MBSR, mindfulness, stress

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Rest and Relaxation
    Arm Type
    Active Comparator
    Arm Description
    three-day relaxation retreat without mindfulness components
    Arm Title
    Mindfulness-Based Meditation
    Arm Type
    Experimental
    Arm Description
    three-day mindfulness-based meditation retreat
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindfulness-Based Stress Reduction
    Other Intervention Name(s)
    MBSR
    Intervention Description
    three-day mindfulness-based meditation retreat program
    Primary Outcome Measure Information:
    Title
    Functional Neural Activity
    Description
    Neural response to emotionally evocative stimuli including stressors related to be unemployed
    Time Frame
    Change from randomization to 1 week
    Secondary Outcome Measure Information:
    Title
    Brain volume
    Description
    Change in volume of brain areas associated with emotional reactivity
    Time Frame
    Change from randomization to 1 week
    Title
    Pro-inflammation
    Description
    Change in protein measures of inflammation
    Time Frame
    from baseline to four-month follow-up
    Title
    Psychological Distress
    Description
    self-reported psychological distress
    Time Frame
    baseline to four month follow-up
    Title
    Cortisol Levels
    Description
    Levels of cortisol were assessed from a small sample of participants' hair
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    24 Years
    Maximum Age & Unit of Time
    52 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    J. David Creswell, PhD
    Organizational Affiliation
    Carnegie Mellon University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28323668
    Citation
    Taren AA, Gianaros PJ, Greco CM, Lindsay EK, Fairgrieve A, Brown KW, Rosen RK, Ferris JL, Julson E, Marsland AL, Creswell JD. Mindfulness Meditation Training and Executive Control Network Resting State Functional Connectivity: A Randomized Controlled Trial. Psychosom Med. 2017 Jul/Aug;79(6):674-683. doi: 10.1097/PSY.0000000000000466.
    Results Reference
    derived
    PubMed Identifier
    27021514
    Citation
    Creswell JD, Taren AA, Lindsay EK, Greco CM, Gianaros PJ, Fairgrieve A, Marsland AL, Brown KW, Way BM, Rosen RK, Ferris JL. Alterations in Resting-State Functional Connectivity Link Mindfulness Meditation With Reduced Interleukin-6: A Randomized Controlled Trial. Biol Psychiatry. 2016 Jul 1;80(1):53-61. doi: 10.1016/j.biopsych.2016.01.008. Epub 2016 Jan 29.
    Results Reference
    derived
    PubMed Identifier
    26048176
    Citation
    Taren AA, Gianaros PJ, Greco CM, Lindsay EK, Fairgrieve A, Brown KW, Rosen RK, Ferris JL, Julson E, Marsland AL, Bursley JK, Ramsburg J, Creswell JD. Mindfulness meditation training alters stress-related amygdala resting state functional connectivity: a randomized controlled trial. Soc Cogn Affect Neurosci. 2015 Dec;10(12):1758-68. doi: 10.1093/scan/nsv066. Epub 2015 Jun 5.
    Results Reference
    derived

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    Mindfulness-Based Meditation to Treat Stress in Unemployed Community Adults

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