Clinical trial NCT01057368: The Effects of Well-being Interventions on Affect, Attention, Sleep, Social Stress and Pain Regulation
Official title: The Effects of Well-being Interventions on Affect, Attention, Sleep, Social Stress and Pain Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health
Mental Health
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2010-01-27
Enrollment: 161
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: MRI BOLD
timeFrame: Pre, Post, Follow-up (WL & LTP)
measure: EEG
timeFrame: Pre, post, & follow-up (WL & LTP)
measure: Salivary Cortisol
timeFrame: Pre, post, & follow-up (WL & LTP)
measure: Behavioral
timeFrame: Pre, post, & follow-up (WL & LTP)
measure: Self-report
timeFrame: Pre, post, & follow-up (WL & LTP)
Secondary outcomes:
measure: Self-report
timeFrame: Pre, post, & follow-up (WL & LTP)
Other outcomes:
Locations:
city: Madison
country: United States
facility: The Wisconsin Sleep Laboratory
state: Wisconsin
city: Madison
country: United States
facility: UW-Health Sports Medicine & Integrative Medicine Program
state: Wisconsin
city: Madison
country: United States
facility: UW-Madison, Laboratory for Affective Neuroscience
state: Wisconsin
Study officials:
affiliation: UW-Madison
name: Richard J Davidson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.