Mindfulness-Based Meditation to Treat Stress in Unemployed Community Adults

Inflammation Clinical Trial

Official title:

Stress Reduction and Healthy Living in Pittsburgh

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01628809
• Other study ID #: HLS-2011
• Status: Completed
• Phase: N/A
• First received: June 20, 2012
• Last updated: July 27, 2015
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: July 2015
• Source: Carnegie Mellon University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Years to 52 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Stress

Intervention

Behavioral:
• Mindfulness-Based Stress Reduction
three-day mindfulness-based meditation retreat program

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Carnegie Mellon University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Neural Activity	Neural response to emotionally evocative stimuli including stressors related to be unemployed	Change from randomization to 1 week	No
Secondary	Brain volume	Change in volume of brain areas associated with emotional reactivity	Change from randomization to 1 week	No
Secondary	Pro-inflammation	Change in protein measures of inflammation	from baseline to four-month follow-up	No
Secondary	Psychological Distress	self-reported psychological distress	baseline to four month follow-up	No
Secondary	Cortisol Levels	Levels of cortisol were assessed from a small sample of participants' hair	1 day	No