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

June 3, 2014 updated by: University of Wisconsin, Madison
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Mindfulness Based Stress Reduction
Behavioral: Mindfulness Based Stress Reduction (MBSR)
8-week class designed to enhance well-being through training in mindfulness meditation
Other Names:
  • MBSR
ACTIVE_COMPARATOR: Health Enhancement Program
Behavioral: Health Enhancement Program (HEP)
8-week class designed to enhance well-being through training in physical activity, functional movement, music therapy, and nutrition
Other Names:
  • HEP
NO_INTERVENTION: Wait List Controls
ACTIVE_COMPARATOR: Long Term Meditators
Behavioral: Day of intensive meditation practice
Long-term meditators practice for ~6 hours of meditation at each time point

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Self-report
Time Frame: Pre, post, & follow-up (WL & LTP)
Pre, post, & follow-up (WL & LTP)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Richard J Davidson, PhD, UW-Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

January 22, 2010

First Submitted That Met QC Criteria

January 22, 2010

First Posted (ESTIMATE)

January 27, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 5, 2014

Last Update Submitted That Met QC Criteria

June 3, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • WBP01-AT004952
  • P01AT004952 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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