MindfulnessNCT02157766
Wisconsin Center for the Neuroscience and Psychophysiology of Meditation
A study testing Intensive Meditation Practice, Mindfulness Based Stress Reduction and Health Enhancement Program in people with Mindfulness and Compassion, run by University of Wisconsin, Madison at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, Compassion, Meditation
- What is being tested?
- Intensive Meditation Practice, Mindfulness Based Stress Reduction and Health Enhancement Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 457 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2014to 14 Apr 2019
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
- 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.
- 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.
Who cannot join
- 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
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- 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.
- 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.
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
UW Madison, Center for Investigating Healthy Minds at the Waisman Center
Madison, Wisconsin, 53705
UW-Madison, Asthma, Allergy and Pulmonary Research Center
Madison, Wisconsin, 53705
UW-Health Sports Medicine & Integrative Medicine Program
Madison, Wisconsin, 53711
Center for Sleep and Consciousness (and Wisconsin Sleep Clinic)
Madison, Wisconsin, 53719
About this study
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.
- Conditions
- Mindfulness, Compassion, Meditation, Mental Health, Asthma
- Being tested
- Intensive Meditation Practice, Mindfulness Based Stress Reduction, Health Enhancement Program
- Keywords
- Mental Health, Asthma, Mindfulness, Compassion, Meditation
- Medical subject headings
- Psychological Well-Being, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Meditation PracticeBehavioural
Long term meditators complete three days of of mindfulness or compassion/loving kindness meditation at T2 and T3 (one meditation type per visit).
Mindfulness Based Stress ReductionBehavioural
Also called MBSR
8 week class designed to enhance well-being through training in mindfulness.
Health Enhancement ProgramBehavioural
Also called HEP
8 week class designed to enhance well-being through training in physical activity, functional movement, music therapy and nutrition.
| Study group | Role | What they receive |
|---|---|---|
| MNP with Asthma: Mindfulness Based Stress Reduction | Active comparator | Not described Receives: Behavioral: Mindfulness Based Stress Reduction |
| MNP w/ Asthma: Wait List Control | No intervention | Not described |
| MNP, no asthma - Mindfulness Based Stress Reduction | Active comparator | Not described Receives: Behavioral: Mindfulness Based Stress Reduction |
| MNP, no asthma: Health Enhancement Program | Active comparator | Not described Receives: Behavioral: Health Enhancement Program |
| MNP, no asthma - Wait List Control | No intervention | Not described |
| Long Term Meditator | Active comparator | Not described Receives: Behavioral: Intensive Meditation Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 3 months, 10 months
Change in slope measure of diurnal cortisol following a well-being intervention relative to baseline.
Measured: 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
Measured: baseline (pre), 3 months (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2018
- Study completion14 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Richard J Davidson, PhD, Principal investigator, UW-Madison, Center for Investigating Healthy Minds at the Waisman Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157766
- Sponsor's protocol ID
- 2014-0116
- Other IDs
- P01AT004952
- Status last verified
- May 2019
- First submitted
- 27 May 2014
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36177306
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wisconsin Center for the Neuroscience and Psychophysiology of Meditation
- ClinicalTrials.gov ID
- NCT02157766
- Acronym / sponsor ID
- 2014-0116
- Conditions
- Mindfulness, Compassion, Meditation, Mental Health, Asthma
- Keywords
- Mental Health, Asthma, Mindfulness, Compassion, Meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2014
- Primary completion
- Nov 2018 (actual)
- Study completion
- 14 Apr 2019 (actual)
- First posted
- 6 Jun 2014 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MNP with Asthma: Mindfulness Based Stress Reduction | Active comparator | Behavioral: Mindfulness Based Stress Reduction |
| MNP w/ Asthma: Wait List Control | No intervention | – |
| MNP, no asthma - Mindfulness Based Stress Reduction | Active comparator | Behavioral: Mindfulness Based Stress Reduction |
| MNP, no asthma: Health Enhancement Program | Active comparator | Behavioral: Health Enhancement Program |
| MNP, no asthma - Wait List Control | No intervention | – |
| Long Term Meditator | Active comparator | Behavioral: Intensive Meditation Practice |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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
Key exclusion criteria (64 listed)
- 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.
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 |
|---|---|---|
| Intensive Meditation PracticeLong term meditators complete three days of of mindfulness or compassion/loving kindness meditation at T2 and T3 (one meditation type per visit). | Behavioural | Long Term Meditator |
| Mindfulness Based Stress ReductionAlso: MBSR8 week class designed to enhance well-being through training in mindfulness. | Behavioural | MNP with Asthma: Mindfulness Based Stress Reduction, MNP, no asthma - Mindfulness Based Stress Reduction |
| Health Enhancement ProgramAlso: HEP8 week class designed to enhance well-being through training in physical activity, functional movement, music therapy and nutrition. | Behavioural | MNP, no asthma: Health Enhancement Program |
Primary outcome
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.
Time frame: baseline, 3 months, 10 months
Change in slope measure of diurnal cortisol following a well-being intervention relative to baseline.
Time frame: 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
Time frame: baseline (pre), 3 months (post-intervention)
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 3 Aug 2021.
- Derived from this study: PubMed 36177306Higgins 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.
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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.
Richard J Davidson, PhD principal investigator
UW-Madison, Center for Investigating Healthy Minds at the Waisman Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Meditation Practice, Mindfulness Based Stress Reduction and Health Enhancement Program in people with Mindfulness and Compassion, run by University of Wisconsin, Madison at 4 sites in United States.
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 28 inclusion and 64 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 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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. (time frame: baseline, 3 months, 10 months). The study lists 3 primary outcomes in all. 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 NCT02157766, which also lists 1 linked publication.
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 3 Aug 2021.