Mindfulness-Based Meditation to Treat Stress in Unemployed Community Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Stress Reduction and Healthy Living in Pittsburgh

Conditions
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Stress, Inflammation

Intervention / Treatment
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* Behavioral: Mindfulness-Based Stress Reduction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 52 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rest and Relaxation<br>three-day relaxation retreat without mindfulness components | Behavioral: Mindfulness-Based Stress Reduction<br>* three-day mindfulness-based meditation retreat program<br>* Other names: MBSR;|
| Experimental: Mindfulness-Based Meditation<br>three-day mindfulness-based meditation retreat | Behavioral: Mindfulness-Based Stress Reduction<br>* three-day mindfulness-based meditation retreat program<br>* Other names: MBSR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Neural Activity | Neural response to emotionally evocative stimuli including stressors related to be unemployed | Change from randomization to 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain volume | Change in volume of brain areas associated with emotional reactivity | Change from randomization to 1 week | 
| Pro-inflammation | Change in protein measures of inflammation | from baseline to four-month follow-up | 
| Psychological Distress | self-reported psychological distress | baseline to four month follow-up | 
| Cortisol Levels | Levels of cortisol were assessed from a small sample of participants' hair | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MBSR, mindfulness, stress