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

NCT ID: NCT01057368

Last Updated: 2014-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Health Mental Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Mindfulness Based Stress Reduction

Group Type ACTIVE_COMPARATOR

Mindfulness Based Stress Reduction (MBSR)

Intervention Type BEHAVIORAL

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

Health Enhancement Program

Group Type ACTIVE_COMPARATOR

Health Enhancement Program (HEP)

Intervention Type BEHAVIORAL

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

Wait List Controls

Group Type NO_INTERVENTION

No interventions assigned to this group

Long Term Meditators

Group Type ACTIVE_COMPARATOR

Day of intensive meditation practice

Intervention Type BEHAVIORAL

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

Interventions

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Day of intensive meditation practice

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

Intervention Type BEHAVIORAL

Mindfulness Based Stress Reduction (MBSR)

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

Intervention Type BEHAVIORAL

Health Enhancement Program (HEP)

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

Intervention Type BEHAVIORAL

Other Intervention Names

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MBSR HEP

Eligibility Criteria

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Inclusion Criteria

* MRI safe

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard J Davidson, PhD

Role: PRINCIPAL_INVESTIGATOR

UW-Madison

Locations

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The Wisconsin Sleep Laboratory

Madison, Wisconsin, United States

Site Status

UW-Health Sports Medicine & Integrative Medicine Program

Madison, Wisconsin, United States

Site Status

UW-Madison, Laboratory for Affective Neuroscience

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35899379 (View on PubMed)

Other Identifiers

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P01AT004952

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WBP01-AT004952

Identifier Type: -

Identifier Source: org_study_id

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