CClinicalTrials.gg
CompletedNCT01057368Updated Jun 5, 2014

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

An interventional study of Day of intensive meditation practice and Mindfulness Based Stress Reduction (MBSR) in Health and Mental Health, sponsored by University of Wisconsin, Madison. Completed at 3 sites in United States. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-05.

Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
161
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Health
  • Mental Health
03

In context

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.

Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • MRI safe

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Investigator)
Enrollment
161 participants (actual)

Study arms

  • Active comparator
    Mindfulness Based Stress Reduction

    Behavioral: Mindfulness Based Stress Reduction (MBSR)

  • Active comparator
    Health Enhancement Program

    Behavioral: Health Enhancement Program (HEP)

  • No intervention
    Wait List Controls
  • Active comparator
    Long Term Meditators

    Behavioral: Day of intensive meditation practice

Interventions

  • BehavioralDay of intensive meditation practice

    Long-term meditators practice for \~6 hours of meditation at each time point

  • BehavioralMindfulness Based Stress Reduction (MBSR)

    8-week class designed to enhance well-being through training in mindfulness meditation

    Also known as: MBSR

  • BehavioralHealth Enhancement Program (HEP)

    8-week class designed to enhance well-being through training in physical activity, functional movement, music therapy, and nutrition

    Also known as: HEP

06

What researchers measure

Primary outcomes

  1. MRI BOLD

    Time frame: Pre, Post, Follow-up (WL & LTP)

  2. EEG

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

  3. Salivary Cortisol

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

  4. Behavioral

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

  5. Self-report

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

Secondary outcomes

  1. Self-report

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

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Study locations

3 sites
  • The Wisconsin Sleep Laboratory
    Madison, Wisconsin 53705, United States
  • UW-Health Sports Medicine & Integrative Medicine Program
    Madison, Wisconsin 53705, United States
  • UW-Madison, Laboratory for Affective Neuroscience
    Madison, Wisconsin 53705, United States
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References and documents

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. Erratum In: Am J Psychiatry. 2022 Oct;179(10):767. doi: 10.1176/appi.ajp.21020145correction. PubMed 35899379 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01057368
Lead sponsor
University of Wisconsin, Madison
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Responsible party
Sponsor
First posted
Jan 27, 2010
Start date
Nov 2009
Primary completion
Mar 2012
Completion
Mar 2012
Last update
Jun 5, 2014

Study contacts

Richard J Davidson, PhD
principal investigator · UW-Madison

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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