Mindfulness-Based Meditation to Treat Stress in Unemployed Community Adults

NCT ID: NCT01628809

Last Updated: 2015-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-12-31

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.

Conditions

Stress; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Rest and Relaxation

three-day relaxation retreat without mindfulness components

Group Type: ACTIVE_COMPARATOR

Mindfulness-Based Stress Reduction

Intervention Type: BEHAVIORAL

three-day mindfulness-based meditation retreat program

Mindfulness-Based Meditation

three-day mindfulness-based meditation retreat

Group Type: EXPERIMENTAL

Mindfulness-Based Stress Reduction

Intervention Type: BEHAVIORAL

three-day mindfulness-based meditation retreat program

Interventions

Mindfulness-Based Stress Reduction

three-day mindfulness-based meditation retreat program

Intervention Type: BEHAVIORAL

Other Intervention Names

MBSR

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

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 52 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carnegie Mellon University

OTHER

Sponsor Role: lead

Responsible Party

David Creswell

Dr. J. David Creswell

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

J. David Creswell, PhD

Role: PRINCIPAL_INVESTIGATOR

Carnegie Mellon University

References

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.

Reference Type: DERIVED

PMID: 28323668 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27021514 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26048176 (View on PubMed)

Other Identifiers

HLS-2011

Identifier Type: -

Identifier Source: org_study_id