The Effects of Mindfulness Training on Pain Regulation, Negative Affect, Attention, and Social Stress

NCT01301105 | Completed

• 1 other identifier: AT002114-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The project's objective is to explore the impact of Mindfulness-Based-Stress-Reduction (MBSR) on pain regulation, social stress, basic affective and attention functions, and on the brain, immune, and endocrine mechanisms that subserve these processes. Specifically, the investigators hypothesize that participants undergoing MBSR training will show decreased emotional distress on self-report measures, increased sustained attention on a behavioral task, decreased stress levels on a social stress test, decreased general psychosocial stress as indexed by diurnal salivary cortisol profile, changes in inflammatory response, modulation of cellular aging, and different neural patterns in response to thermal pain and aversive visual stimuli as indexed by functional Magnetic Resonance Imaging (fMRI). To test these hypotheses, the study will recruit 50 participants through the UW-Madison Integrative Medicine Program. All participants will be randomly assigned either to an 8-week MBSR program or to an 8-week training program in health-enhancement. At the conclusion of the study, participants will be invited to participate to the second class should they be interested. Participants will complete self-report questionnaires, behavioral tasks, fMRI scanning, cortisol sampling, and blood sampling before training begins, after the first program ends, and again four months after the first program ends and prior to the second program. If hypotheses are supported, the study may benefit participants by reducing their psychological distress, increasing their well-being, and helping them better manage pain and aversive stimuli. There are no other direct benefits to participants. Potential risks associated with fMRI include ferromagnetic collision, neurostimulation effects, and psychological discomfort. Potential risks to subjects include slight potential discomfort in providing saliva samples, discomfort of painful thermal stimulation, stress associated with the Trier Social Stress Test, some psychological discomfort from viewing disturbing photographs as part of the compassion fMRI study, and breach of confidentiality. Consent for the present study will entail both written and verbal descriptions of the protocol. Subjects will be informed that their participation is completely voluntary, and that they can withdraw at any time.

Conditions

Focus on Pain Regulation Mechanisms; Social Stress Mechanisms; Basic Affective Mechanisms; Attention Mechanisms; Brain Mechanisms; Immune Mechanisms; Endocrine Mechanisms

Keywords

pain regulation; social stress; affect; attention; brain; immune; endocrine

Study Arms (2)

Health Enhancement Program (HEP)

PLACEBO COMPARATOR

Intervention designed to be effective and structurally equivalent to Mindfulness Based Stress Reduction (MBSR) but without a mindfulness component. Designed as an active control for MBSR to isolate mindfulness as an active ingredient.

Behavioral: Health Enhancement Program (HEP)

Mindfulness Based Stress Reduction (MBSR)

ACTIVE COMPARATOR

Behavioral: Mindfulness Based Stress Reduction (MBSR)

Interventions

Mindfulness Based Stress Reduction (MBSR) BEHAVIORAL

8 week class in stress reduction through instruction in mindfulness related techniques.

Mindfulness Based Stress Reduction (MBSR)

Health Enhancement Program (HEP) BEHAVIORAL

8-week intervention designed to be structurally equivalent to MBSR but without a mindfulness component. Consists of nutrition, functional movement, physical activity, and music therapy.

Health Enhancement Program (HEP)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Risk Factors
• Able to lie still in the scanner for 90 minutes
• Weighs under 300 pounds
• Factors impacting on the outcome measures
• years old
• Right-handed
• No previous experience with meditation.
• No daily practice with other mind-body techniques (e.g., yoga, tai-chi, but previous exposure to yoga is okay)
• In good general health as determined by the investigator
• Logistic Issues
• Able to walk
• Able to understand and speak English
• Able to provide written consent prior to admission
• Able to see without glasses (as if looking through binoculars)

You may not qualify if:

• Risk Factors
• Any metallic implants, such as prostheses that cannot be removed, aneurysm clip-S, dental or orthodontic (filings are okay), or orthopedic (e.g., pins, rods, screws, nails) \[okay with doctors note\]
• Any electronic implants, such as cardiac pacemakers, cardiac defibrillator, artificial heart valve, cardiac pace wires,
• Lens implants prior to 1983
• Breast/penile, electrodes, neurostimulators/biostimulators, pumps (e.g. drug infusion device), bone or socket implants (Check with PI or MR technician)
• Any type of prosthesis
• Any permanent cosmetics (e.g., eyeliner) prior to 1975
• Any tattoos on upper body prior to 1975
• Any irremovable non plastic body piercing(s)
• Has ever worked as an occupational metal grinder without protective glasses
• Has ever worked with metal as a hobby without protective glasses
• Has ever had or sought medical attention for metal in the eyes \[requires orbit x-ray\]
• Has ever has metal fragments removed from eyes \[requires orbit x-ray\]
• Has ever been struck by a gun shot, B.B. or shrapnel, and the bullet stuck \[judgement\]
• Has a history of any metal in body

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

• MacCoon DG, MacLean KA, Davidson RJ, Saron CD, Lutz A. No sustained attention differences in a longitudinal randomized trial comparing mindfulness based stress reduction versus active control. PLoS One. 2014 Jun 23;9(6):e97551. doi: 10.1371/journal.pone.0097551. eCollection 2014.

  PMID: 24955584 DERIVED

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Antoine Lutz, Ph.D.

  UW-Madison

  PRINCIPAL INVESTIGATOR

• Richard Davidson, Ph.D.

  UW-Madison

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: February 23, 2011
• Study Start: October 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: October 5, 2015

Record last verified: 2011-05

Locations

US (1)