The Effects of Mindfulness Training on Pain Regulation, Negative Affect, Attention, and Social Stress
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|ClinicalTrials.gov Identifier: NCT01301105|
Recruitment Status : Completed
First Posted : February 23, 2011
Last Update Posted : October 5, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Focus on Pain Regulation Mechanisms Social Stress Mechanisms Basic Affective Mechanisms Attention Mechanisms Brain Mechanisms Immune Mechanisms Endocrine Mechanisms||Behavioral: Mindfulness Based Stress Reduction (MBSR) Behavioral: Health Enhancement Program (HEP)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effects of Mindfulness Training on Pain Regulation, Negative Affect, Attention, and Social Stress.|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
Placebo Comparator: Health Enhancement Program (HEP)
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)
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.
|Active Comparator: Mindfulness Based Stress Reduction (MBSR)||
Behavioral: Mindfulness Based Stress Reduction (MBSR)
8 week class in stress reduction through instruction in mindfulness related techniques.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01301105
|United States, Wisconsin|
|University of Wisconsin-Madison|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator:||Antoine Lutz, Ph.D.||UW-Madison|
|Study Director:||Richard Davidson, Ph.D.||UW-Madison|