Wisconsin Center for the Neuroscience and Psychophysiology of Meditation
2 other identifiers
interventional
457
1 country
4
Brief Summary
The Wisconsin Center for the Neuroscience and Psychophysiology of Meditation will be a highly focused center dedicated to novel and cutting edge research on the mechanisms by which meditation works. The core set of hypotheses for this Center focus on the mechanisms of two common meditation practices: Mindfulness Meditation (MM) and Loving-Kindness/Compassion Meditation (LKM-CO), both taught in Mindfulness-Based Stress Reduction (MBSR). The investigators will study both Long-Term Meditators (LTMs) as well as meditation-naïve participants (MNPs). The latter group will be randomly assigned to MBSR, a rigorously matched comparison intervention called the Health Enhancement Program (HEP; MacCoon et al., 2012), or to a Wait List (WL) control group. This will give us a comprehensive view of changes that are produced by meditation practices per se, changes generically associated with interventions designed to promote well-being, and changes that might be effects of repeating testing protocols across multiple occasions. In addition, the inclusion of both novice and experienced meditators provides a wide range of practice experience that will provide critical information on dose-related effects, information that is lacking in the research literature today. Each of the projects is focused on examining the brain mechanisms and peripheral biological correlates of meditation. Project 1 (Davidson) will examine the impact of the explicit use of mindfulness and loving-kindness/compassion strategies on emotion regulation, specifically neural, biobehavioral and hormonal indices of reactivity to and recovery from pictures of human suffering and flourishing. Project 2 (Rosenkranz) will investigate the brain to periphery pathways through which psychological factors contribute to the expression of asthma symptoms. In addition, it will examine the efficacy of meditation training in reducing the inflammatory response to an allergen in asthmatic individuals by reducing the reactivity of emotion-related neural circuitry. Project 3 (Tononi) will examine whether the previously reported increase in gamma oscillations during Non-REM (NREM) sleep in meditators is associated with changes in sleep mentation (Ferrarelli et al. 2013). In addition, project 3 will examine relations between meditation-induced changes in brain activity during sleep and brain activity and cognitive function during wakefulness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2014
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2014
CompletedFirst Posted
Study publicly available on registry
June 6, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2019
CompletedAugust 3, 2021
May 1, 2019
4.2 years
May 27, 2014
July 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in temporal dynamics of response to emotional anticipation task (fMRI) as a result of short term meditation practice OR 8 week training in meditation or health wellness interventions.
baseline, 3 months, 10 months
Change in slope measure of diurnal cortisol following a well-being intervention relative to baseline.
baseline (pre-intervention), 3 months (post-intervention), 10 months (follow-up)
Difference between groups (MBSR, WL) on change in lung function from pre-training to post-training
baseline (pre), 3 months (post-intervention)
Study Arms (6)
MNP with Asthma: Mindfulness Based Stress Reduction
ACTIVE COMPARATORMNP w/ Asthma: Wait List Control
NO INTERVENTIONMNP, no asthma - Mindfulness Based Stress Reduction
ACTIVE COMPARATORMNP, no asthma: Health Enhancement Program
ACTIVE COMPARATORMNP, no asthma - Wait List Control
NO INTERVENTIONLong Term Meditator
ACTIVE COMPARATORInterventions
Long term meditators complete three days of of mindfulness or compassion/loving kindness meditation at T2 and T3 (one meditation type per visit).
8 week class designed to enhance well-being through training in mindfulness.
8 week class designed to enhance well-being through training in physical activity, functional movement, music therapy and nutrition.
Eligibility Criteria
You may qualify if:
- Able to provide valid informed consent to participate by signing/dating a consent form.
- Fluent English speaker
- MRI safe - Not excluded based on magnetic resonance Screening Form
- years old
- Pre-albuterol FEV1 ≥ 60% while holding meds
- Physician's diagnosis of asthma - via clinical assessment, reversibility or airway hyperresponsivity;
- Ability to provide blood samples with relatively easy vascular access
- Uses acceptable contraception
- Evidence of persistent, residual inflammation (≥2% sputum eosinophils OR peripheral blood eosinophils ≥ 150 OR eNO of 30+
- Must be US citizen, green card holder or have an F-1 or J-1 visa. This is required in order to be able to pay participants.
You may not qualify if:
- Pregnant, wanting to become pregnant, breast feeding or less than 6 months post-partum.
- Taking prescribed psychotropic or central nervous system altering medications (may be included with the PIs discretion).
- History of a diagnosed Bipolar Disorder, Schizophrenia, or Schizoaffective Disorder. Diagnosed episode of Major Depression unless it was more than 1 year ago. Diagnosed eating disorder or anxiety disorder unless it was more than 1 year ago. (May be included with the PIs discretion).
- Excluded based upon the screening visit
- Some ongoing medical problems will be excluded based on team judgments about whether they will affect a participant's ability to participate in the study procedures or will affect one or more outcome measures.
- Unable to distinguish colors used in Stroop task
- Use of oral corticosteroids
- Inability or unwillingness to withhold medication as detailed below, before each set of laboratory assessments:
- Leukotriene Inhibitors - 2 days
- Zyrtec - 5 days
- Allegra/Claritin - 4 days
- Antihistamines - 2 days
- Nasal Steroids - 24h
- Albuterol - 6 h
- Inhaled corticosteroids - 12 h
- +66 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
UW Madison, Center for Investigating Healthy Minds at the Waisman Center
Madison, Wisconsin, 53705, United States
UW-Madison, Asthma, Allergy and Pulmonary Research Center
Madison, Wisconsin, 53705, United States
UW-Health Sports Medicine & Integrative Medicine Program
Madison, Wisconsin, 53711, United States
Center for Sleep and Consciousness (and Wisconsin Sleep Clinic)
Madison, Wisconsin, 53719, United States
Related Publications (1)
Higgins ET, Davidson RJ, Busse WW, Klaus DR, Bednarek GT, Goldman RI, Sachs J, Rosenkranz MA. Clinically relevant effects of Mindfulness-Based Stress Reduction in individuals with asthma. Brain Behav Immun Health. 2022 Sep 14;25:100509. doi: 10.1016/j.bbih.2022.100509. eCollection 2022 Nov.
PMID: 36177306DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard J Davidson, PhD
UW-Madison, Center for Investigating Healthy Minds at the Waisman Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2014
First Posted
June 6, 2014
Study Start
September 1, 2014
Primary Completion
November 1, 2018
Study Completion
April 14, 2019
Last Updated
August 3, 2021
Record last verified: 2019-05