HealthNCT01057368

The Effects of Well-being Interventions on Affect, Attention, Sleep, Social Stress and Pain Regulation

A study testing Day of intensive meditation practice, Mindfulness Based Stress Reduction (MBSR) and Health Enhancement Program (HEP) in people with Health and Mental Health, run by University of Wisconsin, Madison at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 25 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Health, Mental Health
What is being tested?: Day of intensive meditation practice, Mindfulness Based Stress Reduction (MBSR) and Health Enhancement Program (HEP)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 161 participants
Where: 3 sitesUnited States
Study dates: Nov 2009to Mar 2012
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 25 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

MRI safe

Who cannot join

Not available for scheduled visits or applicable interventions
Current medical conditions that may affect outcome measures, including chronic inflammatory diseases, asthma, serious mental health diagnoses, chronic pain conditions, a personal history of seizures
Regularly taking medications that may affect outcome measures, including pain medications, corticosteroids, immuno-suppressants, prescription sleep medications, psychotropic medications
Alcohol or non-prescription drug problems
Night-shift worker
Diagnosed sleep disorder or habits, such as late bedtime, that would prevent enough sleep in the laboratory

Show all 11Show fewer

Previous training related to one of the two active interventions for meditation naive participants
Unwillingness or inability to engage in intervention activities as determined by participant or their primary care physician
Currently pregnant or planning on becoming pregnant in the next year
Currently nursing
Current IUD

Trial locations and contacts

3 sites in 1 country.

United States3 sites

The Wisconsin Sleep Laboratory
Madison, Wisconsin, 53705
UW-Health Sports Medicine & Integrative Medicine Program
Madison, Wisconsin, 53705
UW-Madison, Laboratory for Affective Neuroscience
Madison, Wisconsin, 53705

Other trials in United States

About this study

This study is focused on the brain mechanisms and peripheral biological correlates of two different forms of meditation--mindfulness-based and compassion/loving-kindness. Project 1 is focused on the impact of compassion/loving-kindness meditation on emotional reactivity and emotion regulation. Project 2 is focused on the neural and behavioral correlates of mindfulness meditation and attention and pain regulation. In addition, Project 2 will examine the relations between changes in oscillatory rhythms during meditation and attention and pain processing. Project 3 will examine the impact of meditation on spontaneous brain activity during sleep. This project will also examine the impact of intensive meditation on regional changes in slow wave activity during subsequent sleep. Each of these projects will be conducted on the same participants so that interrelations among the various measures collected in the different projects can be examined. We believe that this study will dramatically advance the understanding of the mechanisms by which meditation produces changes in behavioral and biological processes.

Conditions: Health, Mental Health
Being tested: Day of intensive meditation practice, Mindfulness Based Stress Reduction (MBSR), Health Enhancement Program (HEP)
Medical subject headings: Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Day of intensive meditation practiceBehavioural
Long-term meditators practice for ~6 hours of meditation at each time point
Mindfulness Based Stress Reduction (MBSR)Behavioural
Also called MBSR
8-week class designed to enhance well-being through training in mindfulness meditation
Health Enhancement Program (HEP)Behavioural
Also called HEP
8-week class designed to enhance well-being through training in physical activity, functional movement, music therapy, and nutrition

Study groups in NCT01057368
Study group	Role	What they receive
Mindfulness Based Stress Reduction	Active comparator	Not described Receives: Behavioral: Mindfulness Based Stress Reduction (MBSR)
Health Enhancement Program	Active comparator	Not described Receives: Behavioral: Health Enhancement Program (HEP)
Wait List Controls	No intervention	Not described
Long Term Meditators	Active comparator	Not described Receives: Behavioral: Day of intensive meditation practice

What is being measured

The primary outcome is the main question the study is designed to answer.

MRI BOLD
Measured: Pre, Post, Follow-up (WL & LTP)
EEG
Measured: Pre, post, & follow-up (WL & LTP)
Salivary Cortisol
Measured: Pre, post, & follow-up (WL & LTP)
Behavioral
Measured: Pre, post, & follow-up (WL & LTP)
Self-report
Measured: Pre, post, & follow-up (WL & LTP)

Secondary outcomes (1)

Self-report
Measured: Pre, post, & follow-up (WL & LTP)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Mar 2012

First posted27 Jan 2010 (estimated)
Study startNov 2009
Primary completionMar 2012
Study completionMar 2012

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 HealthStudies 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: 161 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01057368
Sponsor's protocol ID: WBP01-AT004952
Other IDs: P01AT004952
Status last verified: Jun 2014
First submitted: 22 Jan 2010
Last updated: 5 Jun 2014
Results posted: No
Data monitoring committee: Yes

Publications

Wielgosz J, Kral TRA, Perlman DM, Mumford JA, Wager TD, Lutz A, Davidson RJ. Neural Signatures of Pain Modulation in Short-Term and Long-Term Mindfulness Training: A Randomized Active-Control Trial. Am J Psychiatry. 2022 Oct;179(10):758-767. doi: 10.1176/appi.ajp.21020145. Epub 2022 Jul 28.
PubMed 35899379

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Well-being Interventions on Affect, Attention, Sleep, Social Stress and Pain Regulation
ClinicalTrials.gov ID: NCT01057368
Acronym / sponsor ID: WBP01-AT004952
Conditions: Health, Mental Health
Study type: Interventional
Recruitment status: Completed
Enrolment: 161 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: Nov 2009
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 27 Jan 2010 (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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (investigator)
Number of arms: 4

Arm	Type	Receives
Mindfulness Based Stress Reduction	Active comparator	Behavioral: Mindfulness Based Stress Reduction (MBSR)
Health Enhancement Program	Active comparator	Behavioral: Health Enhancement Program (HEP)
Wait List Controls	No intervention	–
Long Term Meditators	Active comparator	Behavioral: Day of intensive meditation practice

Who may qualify

Ages: 25 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

MRI safe

Key exclusion criteria (11 listed)

Not available for scheduled visits or applicable interventions
Current medical conditions that may affect outcome measures, including chronic inflammatory diseases, asthma, serious mental health diagnoses, chronic pain conditions, a personal history of seizures
Regularly taking medications that may affect outcome measures, including pain medications, corticosteroids, immuno-suppressants, prescription sleep medications, psychotropic medications
Alcohol or non-prescription drug problems
Night-shift worker

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
Day of intensive meditation practiceLong-term meditators practice for ~6 hours of meditation at each time point	Behavioural	Long Term Meditators
Mindfulness Based Stress Reduction (MBSR)Also: MBSR8-week class designed to enhance well-being through training in mindfulness meditation	Behavioural	Mindfulness Based Stress Reduction
Health Enhancement Program (HEP)Also: HEP8-week class designed to enhance well-being through training in physical activity, functional movement, music therapy, and nutrition	Behavioural	Health Enhancement Program

Primary outcome

MRI BOLD
Time frame: Pre, Post, Follow-up (WL & LTP)
EEG
Time frame: Pre, post, & follow-up (WL & LTP)
Salivary Cortisol
Time frame: Pre, post, & follow-up (WL & LTP)
Behavioral
Time frame: Pre, post, & follow-up (WL & LTP)
Self-report
Time frame: Pre, post, & follow-up (WL & LTP)

1 secondary outcome

Self-report
Time frame: Pre, post, & follow-up (WL & LTP)

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 Jun 2014.
Derived from this study: PubMed 35899379Wielgosz J, Kral TRA, Perlman DM, Mumford JA, Wager TD, Lutz A, Davidson RJ. Neural Signatures of Pain Modulation in Short-Term and Long-Term Mindfulness Training: A Randomized Active-Control Trial. Am J Psychiatry. 2022 Oct;179(10):758-767. doi: 10.1176/appi.ajp.21020145. Epub 2022 Jul 28.

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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

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 11 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 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

MRI BOLD (time frame: Pre, Post, Follow-up (WL & LTP)). The study lists 5 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 NCT01057368, 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 Jun 2014.