Wisconsin Center for the Neuroscience and Psychophysiology of Meditation



Status:Active, not recruiting
Conditions:Asthma, Psychiatric
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:1/11/2019
Start Date:September 2014
End Date:April 2019

Use our guide to learn which trials are right for you!

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 (Busse) 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.


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.

Exclusion Criteria - MNP-NA:

- 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
judged by PI in cases of periodic use (e.g. takes anti-anxiety med only when flying)

- 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.

- 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

- Currently participating in another clinical trial

- Current diagnosis of asthma unless. History of asthma is not cause for exclusion.

- Taking prescribed sleeping medications (may be judged by sleep doctor in cases of
periodic use (e.g. takes sleep med only when traveling internationally))

- Currently diagnosed sleep disorders. Past disorders are a judgment by a doctor from
the sleep clinic.

- Regular night shift worker. (Participants may work periodic night shifts (e.g. one
rotation per month) as long as they are able to sleep at normal times for the study)

- Epworth Sleepiness Scale - sleep lab will judge focusing on whether this a situational
or chronic issue (e.g. dogs waking up vs. awake due to anxiety).

- Insomnia Severity Index - sleep lab will judge focusing on whether this a situational
or chronic issue (e.g. dogs waking up vs. awake due to anxiety).

- STOP-BANG questionnaire - sleep lab will judge focusing on whether this is a
situational or chronic issue (unless question 3 = yes in which case a score >3 will be
excluded).

- Cigarette smoker unless willing to go without a cigarette for 4 hours or more.

- Traveled across more than 3 time zones in the three weeks prior to each study visit.

- Expert in physical activity (e.g. physical therapist, personal trainer), music (music
therapist) or nutrition (nutritionist).

- Significant daily practice with physical activity as scored by the web screen.

- 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 - LTM:

- 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 .

- 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. Long-term practitioners may be judged on these last criteria
because their sleep habits are sometimes very different than meditation naïve
participants. (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)

- Meditation practice for a minimum of 5 years with an average practice of 200
minutes/week, that includes both mindfulness meditation and loving kindness and/or
compassion meditation

- Significant retreat experience - a minimum of five weeks on retreat (with PI's
discretion as financial means can make retreats impossible).

- 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 - LTM:

- 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
judged by PI in cases of periodic use (e.g. takes anti-anxiety med only when flying)

- History of a diagnosed Bipolar Disorder, Schizophrenia, or Schizoaffective Disorder.
Diagnosed episode of Major Depression unless more than 1 year ago. Diagnosed eating
disorder or anxiety disorder unless it was more than 1 year ago. Participants may be
included with a history of these disorders with the PIs discretion.

- Excluded based upon the screening visit (Non-local LTMs will be excluded if they are
not comfortable with the MRI however they may participate in the study if they are not
comfortable with the electrical stimulation.)

- 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

- Currently participating in another clinical trial

- Taking prescribed sleeping medications (may be judged by sleep doctor in cases of
periodic use (e.g. takes sleep med only when traveling internationally))

- Currently diagnosed sleep disorders. Past disorders are a judgment by a doctor from
the sleep clinic.

- Regular night shift worker. (Participants may work periodic night shifts (e.g. one
rotation per month) as long as they are able to sleep at normal times for the study)

- Epworth Sleepiness Scale - sleep lab will judge focusing on whether this a situational
or chronic issue (e.g. dogs waking up vs. awake due to anxiety).

- Insomnia Severity Index - sleep lab will judge focusing on whether this a situational
or chronic issue (e.g. dogs waking up vs. awake due to anxiety).

- STOP-BANG questionnaire - sleep lab will judge focusing on whether this is a
situational or chronic issue (unless question 3 = yes in which case a score >3 will be
excluded).

- Cigarette smoker unless willing to go without a cigarette for 4 hours or more.

- Traveled across more than 3 time zones in the three weeks prior to each study visit.
We found this trial at
4
sites
Madison, Wisconsin 53705
Phone: 608-255-9330
?
mi
from
Madison, WI
Click here to add this to my saved trials
Madison, Wisconsin 53705
Principal Investigator: Richard J Davidson, PhD
Phone: 608-265-8189
?
mi
from
Madison, WI
Click here to add this to my saved trials
Madison, Wisconsin 53705
Principal Investigator: William W Busse, PhD
Phone: 608-263-6183
?
mi
from
Madison, WI
Click here to add this to my saved trials
Madison, Wisconsin 53719
Principal Investigator: Giulio Tononi, PhD MD
Phone: 414-331-6775
?
mi
from
Madison, WI
Click here to add this to my saved trials