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OpenTrials
Completed

NCT Number: NCT01057368

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

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.

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Wisconsin Sleep Laboratory, Madison, Wisconsin, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Day of intensive meditation practice

Behavioral

Long-term meditators practice for ~6 hours of meditation at each time point

mindfulness based stress reduction (MBSR)

Behavioral

8-week class designed to enhance well-being through training in mindfulness meditation

Other names: MBSR

Health Enhancement Program (HEP)

Behavioral

8-week class designed to enhance well-being through training in physical activity, functional movement, music therapy, and nutrition

Other names: HEP

Primary outcomes

  1. MRI BOLD

    Time frame: Pre, Post, Follow-up (WL & LTP)

  2. EEG

    Time frame: Pre, post, & follow-up (WL & LTP)

  3. Salivary Cortisol

    Time frame: Pre, post, & follow-up (WL & LTP)

  4. Behavioral

    Time frame: Pre, post, & follow-up (WL & LTP)

  5. Self-report

    Time frame: Pre, post, & follow-up (WL & LTP)

Secondary outcomes

  1. Self-report

    Time frame: Pre, post, & follow-up (WL & LTP)

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 27, 2010
Registry last updated
Jun 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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