StressNCT01628809
Mindfulness-Based Meditation to Treat Stress in Unemployed Community Adults
A study testing Mindfulness-Based Stress Reduction in people with Stress and Inflammation, run by Carnegie Mellon University.
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. Read more about this study
- Who is it for?
- Ages 24 to 52 years
- Conditions the study is for
- Stress, Inflammation
- What is being tested?
- Mindfulness-Based Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 52 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
About this study
Official title: Stress Reduction and Healthy Living in Pittsburgh
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.
Read the 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
- Being tested
- Mindfulness-Based Stress Reduction
- Keywords
- MBSR, mindfulness, stress
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress ReductionBehavioural
Also called MBSR
three-day mindfulness-based meditation retreat program
| Study group | Role | What they receive |
|---|---|---|
| Rest and Relaxation | Active comparator | three-day relaxation retreat without mindfulness components Receives: Behavioral: Mindfulness-Based Stress Reduction |
| Mindfulness-Based Meditation | Experimental | three-day mindfulness-based meditation retreat Receives: Behavioral: Mindfulness-Based Stress Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Neural Activity
Neural response to emotionally evocative stimuli including stressors related to be unemployed
Measured: Change from randomization to 1 week
Secondary outcomes (4)
Brain volume
Change in volume of brain areas associated with emotional reactivity
Measured: Change from randomization to 1 week
Pro-inflammation
Change in protein measures of inflammation
Measured: from baseline to four-month follow-up
Psychological Distress
self-reported psychological distress
Measured: baseline to four month follow-up
Cortisol Levels
Levels of cortisol were assessed from a small sample of participants' hair
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startJan 2011
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carnegie Mellon University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Creswell, Carnegie Mellon University
- Investigators
- J. David Creswell, PhD, Principal investigator, Carnegie Mellon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628809
- Sponsor's protocol ID
- HLS-2011
- Status last verified
- Jul 2015
- First submitted
- 20 Jun 2012
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28323668Creswell 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.
PubMed 27021514Taren 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.
PubMed 26048176
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Reduction and Healthy Living in Pittsburgh
- ClinicalTrials.gov ID
- NCT01628809
- Acronym / sponsor ID
- HLS-2011
- Conditions
- Stress, Inflammation
- Keywords
- MBSR, mindfulness, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Carnegie Mellon UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rest and Relaxation | Active comparator | Behavioral: Mindfulness-Based Stress Reductionthree-day relaxation retreat without mindfulness components |
| Mindfulness-Based Meditation | Experimental | Behavioral: Mindfulness-Based Stress Reductionthree-day mindfulness-based meditation retreat |
Who may qualify
- Ages
- 24 to 52 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Stress ReductionAlso: MBSRthree-day mindfulness-based meditation retreat program | Behavioural | Mindfulness-Based Meditation, Rest and Relaxation |
Primary outcome
Functional Neural Activity
Time frame: Change from randomization to 1 week
Neural response to emotionally evocative stimuli including stressors related to be unemployed
4 secondary outcomes
Brain volume
Time frame: Change from randomization to 1 week
Pro-inflammation
Time frame: from baseline to four-month follow-up
Psychological Distress
Time frame: baseline to four month follow-up
Cortisol Levels
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
- Derived from this study: PubMed 28323668Taren 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.
- Derived from this study: PubMed 27021514Creswell 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.
- Derived from this study: PubMed 26048176Taren 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.
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. David Creswell, PhD principal investigator
Carnegie Mellon University
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction in people with Stress and Inflammation, run by Carnegie Mellon University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Neural Activity (time frame: Change from randomization to 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01628809, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.