Focus on Pain Regulation MechanismsNCT01301105
The Effects of Mindfulness Training on Pain Regulation, Negative Affect, Attention, and Social Stress
A study testing Mindfulness Based Stress Reduction (MBSR) and Health Enhancement Program (HEP) in people with Focus on Pain Regulation Mechanisms and Social Stress Mechanisms, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The project's objective is to explore the impact of Mindfulness-Based-Stress-Reduction (MBSR) on pain regulation, social stress, basic affective and attention functions, and on the brain, immune, and endocrine mechanisms that subserve these processes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus on Pain Regulation Mechanisms, Social Stress Mechanisms, Basic Affective Mechanisms
- What is being tested?
- Mindfulness Based Stress Reduction (MBSR) and Health Enhancement Program (HEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Apr 2007
- 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
- 1.1 Risk Factors
- Able to lie still in the scanner for 90 minutes
- Weighs under 300 pounds
- 1.2 Factors impacting on the outcome measures
- 18-65 years old
- Right-handed
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- No previous experience with meditation.
- No daily practice with other mind-body techniques (e.g., yoga, tai-chi, but previous exposure to yoga is okay)
- In good general health as determined by the investigator
- 1.3 Logistic Issues
- Able to walk
- Able to understand and speak English
- Able to provide written consent prior to admission
- Able to see without glasses (as if looking through binoculars)
Who cannot join
- 2.1 Risk Factors
- Any metallic implants, such as prostheses that cannot be removed, aneurysm clip-S, dental or orthodontic (filings are okay), or orthopedic (e.g., pins, rods, screws, nails) [okay with doctors note]
- Any electronic implants, such as cardiac pacemakers, cardiac defibrillator, artificial heart valve, cardiac pace wires,
- Lens implants prior to 1983
- Breast/penile, electrodes, neurostimulators/biostimulators, pumps (e.g. drug infusion device), bone or socket implants (Check with PI or MR technician)
- Any type of prosthesis
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- Any permanent cosmetics (e.g., eyeliner) prior to 1975
- Any tattoos on upper body prior to 1975
- Any irremovable non plastic body piercing(s)
- Has ever worked as an occupational metal grinder without protective glasses
- Has ever worked with metal as a hobby without protective glasses
- Has ever had or sought medical attention for metal in the eyes [requires orbit x-ray]
- Has ever has metal fragments removed from eyes [requires orbit x-ray]
- Has ever been struck by a gun shot, B.B. or shrapnel, and the bullet stuck [judgement]
- Has a history of any metal in body
- Diabetes
- Peripheral vascular disease, peripheral arterial disease, Raynaud's disease, or any other diagnosed circulatory disorders
- Body mass index (BMI) below 18.5
- Any involuntary motor disorders
- Has a cochlear implant
- Wears a hearing aid that cannot be taken out (Check with PI or MR technician)
- Wears a hearing aid
- Wears dentures that cannot be removed or contain metal
- A subject who is claustrophobic
- A female subject who is pregnant or has an intrauterine device (IUD)
- Allergic to adhesive tape
- A history of problems of any kind during blood draws
- Women who may be pregnant
- Women who have an intrauterine device (IUD) [okay with a doctors note]
- 2 or more of the following [judgment]
- Diagnosed hypertension?
- Hyperlipidemia
- High cholesterol
- Obesity can be calculated from weight \& height info.
- Smoke cigarettes
- Family history of coronary or atherosclerotic disease (parents/siblings prior to age 55)
- 2.2 Factors impacting on the outcome measures
- Current medical disorders that might make interpretation of scan data difficult
- Has a problem with alcohol or non prescription drugs
- Use of medications that affects CNS function, including psychotropics, opiate medication or corticosteroids, during the last 3 months
- Any prescribed psychotropic medications, currently or during the last 3 months (These include medications for anxiety, depression, or other psychological problems)
- Plans to start taking any prescribed psychotropic medications
- Takes inhaled steroids for asthma? (e.g., Fluticasone)
- Takes any corticosteroids?
- Night shift workers (11 pm to 7 am) d/t potential disruption of cortisol level variability
- Diabetes requiring insulin treatment
- Has TMJ (Temporal Mandibular Joint) disorder or other problems with biting/chewing
- Previous training in meditation
- Currently meditates on a regular basis
- Daily yoga, tai-chi, or Qigong practice
- Engagement in moderate sport and recreational activities more than 5 times a week
- Engagement in vigorous sport and recreational activities more than 4 times a week
- 2.3 Logistic Issues
- Phobia of needles
- Not able to attend an informational session, all class meetings, and all clinic visits
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53705
About this study
Official title: The Effects of Mindfulness Training on Pain Regulation, Negative Affect, Attention, and Social Stress.
The project's objective is to explore the impact of Mindfulness-Based-Stress-Reduction (MBSR) on pain regulation, social stress, basic affective and attention functions, and on the brain, immune, and endocrine mechanisms that subserve these processes. Specifically, the investigators hypothesize that participants undergoing MBSR training will show decreased emotional distress on self-report measures, increased sustained attention on a behavioral task, decreased stress levels on a social stress test, decreased general psychosocial stress as indexed by diurnal salivary cortisol profile, changes in inflammatory response, modulation of cellular aging, and different neural patterns in response to thermal pain and aversive visual stimuli as indexed by functional Magnetic Resonance Imaging (fMRI).
To test these hypotheses, the study will recruit 50 participants through the UW-Madison Integrative Medicine Program. All participants will be randomly assigned either to an 8-week MBSR program or to an 8-week training program in health-enhancement. At the conclusion of the study, participants will be invited to participate to the second class should they be interested. Participants will complete self-report questionnaires, behavioral tasks, fMRI scanning, cortisol sampling, and blood sampling before training begins, after the first program ends, and again four months after the first program ends and prior to the second program.
Read more
If hypotheses are supported, the study may benefit participants by reducing their psychological distress, increasing their well-being, and helping them better manage pain and aversive stimuli. There are no other direct benefits to participants. Potential risks associated with fMRI include ferromagnetic collision, neurostimulation effects, and psychological discomfort. Potential risks to subjects include slight potential discomfort in providing saliva samples, discomfort of painful thermal stimulation, stress associated with the Trier Social Stress Test, some psychological discomfort from viewing disturbing photographs as part of the compassion fMRI study, and breach of confidentiality.
Consent for the present study will entail both written and verbal descriptions of the protocol. Subjects will be informed that their participation is completely voluntary, and that they can withdraw at any time.
- Conditions
- Focus on Pain Regulation Mechanisms, Social Stress Mechanisms, Basic Affective Mechanisms, Attention Mechanisms, Brain Mechanisms, Immune Mechanisms
- Being tested
- Mindfulness Based Stress Reduction (MBSR), Health Enhancement Program (HEP)
- Keywords
- pain regulation, social stress, affect, attention, brain, immune, endocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress Reduction (MBSR)Behavioural
8 week class in stress reduction through instruction in mindfulness related techniques.
Health Enhancement Program (HEP)Behavioural
8-week intervention designed to be structurally equivalent to MBSR but without a mindfulness component. Consists of nutrition, functional movement, physical activity, and music therapy.
| Study group | Role | What they receive |
|---|---|---|
| Health Enhancement Program (HEP) | Placebo comparator | Intervention designed to be effective and structurally equivalent to Mindfulness Based Stress Reduction (MBSR) but without a mindfulness component. Designed as an active control for MBSR to isolate mindfulness as an active ingredient. Receives: Behavioral: Health Enhancement Program (HEP) |
| Mindfulness Based Stress Reduction (MBSR) | Active comparator | Not described Receives: Behavioral: Mindfulness Based Stress Reduction (MBSR) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startOct 2005
- Primary completionApr 2007
- Study completionApr 2007
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 Focus on Pain Regulation MechanismsStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Lutz, Ph.D., Principal investigator, UW-MadisonRichard Davidson, Ph.D., Study director, UW-Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301105
- Sponsor's protocol ID
- AT002114-01
- Status last verified
- May 2011
- First submitted
- 18 Feb 2011
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
MacCoon DG, MacLean KA, Davidson RJ, Saron CD, Lutz A. No sustained attention differences in a longitudinal randomized trial comparing mindfulness based stress reduction versus active control. PLoS One. 2014 Jun 23;9(6):e97551. doi: 10.1371/journal.pone.0097551. eCollection 2014.
PubMed 24955584
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mindfulness Training on Pain Regulation, Negative Affect, Attention, and Social Stress.
- ClinicalTrials.gov ID
- NCT01301105
- Acronym / sponsor ID
- AT002114-01
- Conditions
- Focus on Pain Regulation Mechanisms, Social Stress Mechanisms, Basic Affective Mechanisms, Attention Mechanisms, Brain Mechanisms, Immune Mechanisms
- Keywords
- pain regulation, social stress, affect, attention, brain, immune, endocrine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 23 Feb 2011 (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 project's objective is to explore the impact of Mindfulness-Based-Stress-Reduction (MBSR) on pain regulation, social stress, basic affective and attention functions, and on the brain, immune, and endocrine mechanisms that subserve these processes. Specifically, the investigators hypothesize that participants undergoing MBSR training will show decreased emotional distress on self-report measures, increased sustained attention on a behavioral task, decreased stress levels on a social stress test, decreased general psychosocial stress as indexed by diurnal salivary cortisol profile, changes in inflammatory response, modulation of cellular aging, and different neural patterns in response to thermal pain and aversive visual stimuli as indexed by functional Magnetic Resonance Imaging (fMRI).
To test these hypotheses, the study will recruit 50 participants through the UW-Madison Integrative Medicine Program. All participants will be randomly assigned either to an 8-week MBSR program or to an 8-week training program in health-enhancement. At the conclusion of the study, participants will be invited to participate to the second class should they be interested. Participants will complete self-report questionnaires, behavioral tasks, fMRI scanning, cortisol sampling, and blood sampling before training begins, after the first program ends, and again four months after the first program ends and prior to the second program.
If hypotheses are supported, the study may benefit participants by reducing their psychological distress, increasing their well-being, and helping them better manage pain and aversive stimuli. There are no other direct benefits to participants. Potential risks associated with fMRI include ferromagnetic collision, neurostimulation effects, and psychological discomfort. Potential risks to subjects include slight potential discomfort in providing saliva samples, discomfort of painful thermal stimulation, stress associated with the Trier Social Stress Test, some psychological discomfort from viewing disturbing photographs as part of the compassion fMRI study, and breach of confidentiality.
Consent for the present study will entail both written and verbal descriptions of the protocol. Subjects will be informed that their participation is completely voluntary, and that they can withdraw at any time.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Enhancement Program (HEP) | Placebo comparator | Behavioral: Health Enhancement Program (HEP)Intervention designed to be effective and structurally equivalent to Mindfulness Based Stress Reduction (MBSR) but without a mindfulness component. Designed as an active control for MBSR to isolate mindfulness as an active ingredient. |
| Mindfulness Based Stress Reduction (MBSR) | Active comparator | Behavioral: Mindfulness Based Stress Reduction (MBSR) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 1.1 Risk Factors
- Able to lie still in the scanner for 90 minutes
- Weighs under 300 pounds
- 1.2 Factors impacting on the outcome measures
- 18-65 years old
Key exclusion criteria (55 listed)
- 2.1 Risk Factors
- Any metallic implants, such as prostheses that cannot be removed, aneurysm clip-S, dental or orthodontic (filings are okay), or orthopedic (e.g., pins, rods, screws, nails) [okay with doctors note]
- Any electronic implants, such as cardiac pacemakers, cardiac defibrillator, artificial heart valve, cardiac pace wires,
- Lens implants prior to 1983
- Breast/penile, electrodes, neurostimulators/biostimulators, pumps (e.g. drug infusion device), bone or socket implants (Check with PI or MR technician)
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 Reduction (MBSR)8 week class in stress reduction through instruction in mindfulness related techniques. | Behavioural | Mindfulness Based Stress Reduction (MBSR) |
| Health Enhancement Program (HEP)8-week intervention designed to be structurally equivalent to MBSR but without a mindfulness component. Consists of nutrition, functional movement, physical activity, and music therapy. | Behavioural | Health Enhancement Program (HEP) |
Primary outcome
Not reported in the source record.
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 5 Oct 2015.
- Derived from this study: PubMed 24955584MacCoon DG, MacLean KA, Davidson RJ, Saron CD, Lutz A. No sustained attention differences in a longitudinal randomized trial comparing mindfulness based stress reduction versus active control. PLoS One. 2014 Jun 23;9(6):e97551. doi: 10.1371/journal.pone.0097551. eCollection 2014.
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.
Antoine Lutz, Ph.D. principal investigator
UW-Madison
Richard Davidson, Ph.D. study director
UW-Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Stress Reduction (MBSR) and Health Enhancement Program (HEP) in people with Focus on Pain Regulation Mechanisms and Social Stress Mechanisms, run by University of Wisconsin, Madison at 1 site 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 14 inclusion and 55 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 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01301105, 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 5 Oct 2015.