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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01057368
First received: January 22, 2010
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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 Intervention
Health
Mental Health
Behavioral: Day of intensive meditation practice
Behavioral: Mindfulness Based Stress Reduction (MBSR)
Behavioral: Health Enhancement Program (HEP)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: The Effects of Well-being Interventions on Affect, Attention, Sleep, Social Stress and Pain Regulation

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • MRI BOLD [ Time Frame: Pre, Post, Follow-up (WL & LTP) ] [ Designated as safety issue: No ]
  • EEG [ Time Frame: Pre, post, & follow-up (WL & LTP) ] [ Designated as safety issue: No ]
  • Salivary Cortisol [ Time Frame: Pre, post, & follow-up (WL & LTP) ] [ Designated as safety issue: No ]
  • Behavioral [ Time Frame: Pre, post, & follow-up (WL & LTP) ] [ Designated as safety issue: No ]
  • Self-report [ Time Frame: Pre, post, & follow-up (WL & LTP) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-report [ Time Frame: Pre, post, & follow-up (WL & LTP) ] [ Designated as safety issue: No ]

Enrollment: 161
Study Start Date: November 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057368

Locations
United States, Wisconsin
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
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Richard J Davidson, PhD UW-Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01057368     History of Changes
Other Study ID Numbers: WBP01-AT004952, P01AT004952
Study First Received: January 22, 2010
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 30, 2014