NCT01628809

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 27, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

1.8 years

First QC Date

June 20, 2012

Last Update Submit

July 27, 2015

Conditions

StressInflammation

Keywords

MBSRmindfulnessstress

Outcome Measures

Primary Outcomes (1)

  • Functional Neural Activity

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

    Change from randomization to 1 week

Secondary Outcomes (4)

  • Brain volume

    Change from randomization to 1 week

  • Pro-inflammation

    from baseline to four-month follow-up

  • Psychological Distress

    baseline to four month follow-up

  • Cortisol Levels

    1 day

Study Arms (2)

Rest and Relaxation

ACTIVE COMPARATOR

three-day relaxation retreat without mindfulness components

Behavioral: Mindfulness-Based Stress Reduction

Mindfulness-Based Meditation

EXPERIMENTAL

three-day mindfulness-based meditation retreat

Behavioral: Mindfulness-Based Stress Reduction

Interventions

Mindfulness-Based Stress ReductionBEHAVIORAL

three-day mindfulness-based meditation retreat program

Also known as: MBSR
Mindfulness-Based MeditationRest and Relaxation

Eligibility Criteria

Age24 Years - 52 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 28323668DERIVED

  • 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.

    PMID: 27021514DERIVED

  • 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.

    PMID: 26048176DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • J. David Creswell, PhD

    Carnegie Mellon University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. J. David Creswell

Study Record Dates

First Submitted

June 20, 2012

First Posted

June 27, 2012

Study Start

January 1, 2011

Primary Completion

October 1, 2012

Study Completion

December 1, 2012

Last Updated

July 28, 2015

Record last verified: 2015-07