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

Mental Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057368
• Other study ID #: WBP01-AT004952
• Secondary ID: P01AT004952
• Status: Completed
• Phase: N/A
• First received: January 22, 2010
• Last updated: June 3, 2014
• Start date: November 2009
• Est. completion date: March 2012

Study information

• Verified date: June 2014
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Health
• Mental Health

Intervention

Behavioral:
• Day of intensive meditation practice
Long-term meditators practice for ~6 hours of meditation at each time point
• Mindfulness Based Stress Reduction (MBSR)
8-week class designed to enhance well-being through training in mindfulness meditation
• Health Enhancement Program (HEP)
8-week class designed to enhance well-being through training in physical activity, functional movement, music therapy, and nutrition

Locations

Country	Name	City	State
United States	The Wisconsin Sleep Laboratory	Madison	Wisconsin
United States	UW-Health Sports Medicine & Integrative Medicine Program	Madison	Wisconsin
United States	UW-Madison, Laboratory for Affective Neuroscience	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI BOLD		Pre, Post, Follow-up (WL & LTP)	No
Primary	EEG		Pre, post, & follow-up (WL & LTP)	No
Primary	Salivary Cortisol		Pre, post, & follow-up (WL & LTP)	No
Primary	Behavioral		Pre, post, & follow-up (WL & LTP)	No
Primary	Self-report		Pre, post, & follow-up (WL & LTP)	No
Secondary	Self-report		Pre, post, & follow-up (WL & LTP)	No