The Effects of Well-being Interventions on Affect, Attention, Sleep, Social Stress and Pain Regulation
2 other identifiers
interventional
161
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2009
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 22, 2010
CompletedFirst Posted
Study publicly available on registry
January 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedJune 5, 2014
June 1, 2014
2.3 years
January 22, 2010
June 3, 2014
Conditions
Outcome Measures
Primary Outcomes (5)
MRI BOLD
Pre, Post, Follow-up (WL & LTP)
EEG
Pre, post, & follow-up (WL & LTP)
Salivary Cortisol
Pre, post, & follow-up (WL & LTP)
Behavioral
Pre, post, & follow-up (WL & LTP)
Self-report
Pre, post, & follow-up (WL & LTP)
Secondary Outcomes (1)
Self-report
Pre, post, & follow-up (WL & LTP)
Study Arms (4)
Mindfulness Based Stress Reduction
ACTIVE COMPARATORHealth Enhancement Program
ACTIVE COMPARATORWait List Controls
NO INTERVENTIONLong Term Meditators
ACTIVE COMPARATORInterventions
Long-term meditators practice for \~6 hours of meditation at each time point
8-week class designed to enhance well-being through training in mindfulness meditation
8-week class designed to enhance well-being through training in physical activity, functional movement, music therapy, and nutrition
Eligibility Criteria
You may qualify if:
- MRI safe
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
The Wisconsin Sleep Laboratory
Madison, Wisconsin, 53705, United States
UW-Health Sports Medicine & Integrative Medicine Program
Madison, Wisconsin, 53705, United States
UW-Madison, Laboratory for Affective Neuroscience
Madison, Wisconsin, 53705, United States
Related Publications (1)
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.
PMID: 35899379DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard J Davidson, PhD
UW-Madison
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2010
First Posted
January 27, 2010
Study Start
November 1, 2009
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
June 5, 2014
Record last verified: 2014-06