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Wisconsin Center for the Neuroscience and Psychophysiology of Meditation

Wisconsin Center for the Neuroscience and Psychophysiology of Meditation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02157766
Enrollment
457
Registered
2014-06-06
Start date
2014-09-30
Completion date
2019-04-14
Last updated
2021-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Compassion, Meditation, Mental Health, Mindfulness

Keywords

Mental Health, Asthma, Mindfulness, Compassion, Meditation

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.

Interventions

BEHAVIORALIntensive Meditation Practice

Long term meditators complete three days of of mindfulness or compassion/loving kindness meditation at T2 and T3 (one meditation type per visit).

BEHAVIORALMindfulness Based Stress Reduction

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.

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

- MNP-A: * 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 * 18-65 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.

Exclusion criteria

- MNP-A: * 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 * Use of \>1000 mcg Fluticasone or equivalent ICS per day. * Use of monoclonal antibody that targets eosinophils * Concurrent medications other than for allergies/asthma (must be approved by Dr.) * Current smoker or has a smoking history exceeding 5 pack-years within the last 10 years (i.e. someone who has been a non-smoker for 10 or more years can be enrolled) * Significant previous training or significant current practice in meditation * Completed Mindfulness Based Stress Reduction (MBSR) in the past. * Current meditation practice. Judgment: Participants will be included or excluded at the PIs discretion due to wide variation in responses (e.g. 2 people answer yes, one practices mindfulness 2x/week for 2 years (exclude), the other attends regular religious services (include)). * Significant daily practice with other mind-body techniques * Daily Yoga or Tai Chi Practice - exclude * Other daily practice - judgment. Inclusion Criteria - MNP-NA: * 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 * BMI under 35 * 25-65 years old * Live within 50 miles of Madison, WI. * Takes less than 30 minutes to fall asleep on average. Gets a good night of sleep regularly. Goes to bed before 12 a.m., able to sleep between 11 p.m. & 6 a.m. and sleeps \>= 6 hours. (May be included at sleep doctor's discretion. In some cases, participants may not comply with these criteria but may be entirely safe to participate in the study. For example, a participant may indicate they do not get a good night of sleep due to a situational issue such as a waking baby or a pet as opposed to a chronic issue like insomnia. In these cases, there is no safety issue in having the participant included in the study) * Participants assigned to HEP must have physician signature (on the Physician Authorization Form - PAF) indicating it is safe for them to participate in our interventions as some participant characteristics, such as a family history of coronary or atherosclerotic disease, represent risk factors that together may make the HEP intervention inadvisable; The process is consistent for ANY person who wishes to participate in any sort of physical activity class at the UW Health Research Park Clinic. * 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.

Design outcomes

Primary

MeasureTime frame
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-trainingbaseline (pre), 3 months (post-intervention)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026