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

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Completed
CT.gov ID
NCT01057368
Collaborator
National Center for Complementary and Integrative Health (NCCIH) (NIH)
161
Enrollment
3
Locations
4
Arms
28
Duration (Months)
53.7
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Day of intensive meditation practice
  • Behavioral: Mindfulness Based Stress Reduction (MBSR)
  • Behavioral: Health Enhancement Program (HEP)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
161 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Investigator)
Primary Purpose:
Basic Science
Official Title:
The Effects of Well-being Interventions on Affect, Attention, Sleep, Social Stress and Pain Regulation
Study Start Date :
Nov 1, 2009
Actual Primary Completion Date :
Mar 1, 2012
Actual Study Completion Date :
Mar 1, 2012

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. MRI BOLD [Pre, Post, Follow-up (WL & LTP)]

    2. EEG [Pre, post, & follow-up (WL & LTP)]

    3. Salivary Cortisol [Pre, post, & follow-up (WL & LTP)]

    4. Behavioral [Pre, post, & follow-up (WL & LTP)]

    5. Self-report [Pre, post, & follow-up (WL & LTP)]

    Secondary Outcome Measures

    1. Self-report [Pre, post, & follow-up (WL & LTP)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Wisconsin Sleep Laboratory Madison Wisconsin United States 53705
    2 UW-Health Sports Medicine & Integrative Medicine Program Madison Wisconsin United States 53705
    3 UW-Madison, Laboratory for Affective Neuroscience Madison Wisconsin United States 53705

    Sponsors and Collaborators

    • University of Wisconsin, Madison
    • National Center for Complementary and Integrative Health (NCCIH)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Wisconsin, Madison
    ClinicalTrials.gov Identifier:
    NCT01057368
    Other Study ID Numbers:
    • WBP01-AT004952
    • P01AT004952
    First Posted:
    Jan 27, 2010
    Last Update Posted:
    Jun 5, 2014
    Last Verified:
    Jun 1, 2014

    Study Results

    No Results Posted as of Jun 5, 2014