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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
161

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Complementary and Integrative Health (NCCIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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