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Brain Mechanisms Supporting Meditation-based Analgesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03414138
Recruitment Status : Completed
First Posted : January 29, 2018
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Fadel Zeidan, University of California, San Diego

Brief Summary:
Mindfulness meditation has been shown to reduce pain in experimental and clinical settings, and the neural mechanisms underlying this analgesia are distinct from that of placebo related beliefs in the utility of the meditation. Although previous studies have identified potential cortical and sub-cortical targets responsible for mediating these effects, the connectional relationships between them remains largely unexplored. The present study will use blood-oxygen-level dependent (BOLD) neuroimaging to assess functional connections supporting mindfulness meditation.

Condition or disease Intervention/treatment Phase
Pain Behavioral: Mindfulness Training Behavioral: Book Listening Control Not Applicable

Detailed Description:

Mindfulness meditation, significantly reduces pain in experimental and clinical settings. Although findings from this laboratory provide novel insights into some of the brain mechanisms supporting the modulation of pain by meditation , the specific analgesic mechanisms engaged during mindfulness meditation remain poorly characterized.

To date, there are no studies that have identified the neurofunctional connections supporting mindfulness meditation-based pain relief. Employing fMRI, the objective of this study will be to determine the neural systems of action supporting mindfulness-based pain relief. The study will determine if higher order brain regions are involved in mindfulness-based analgesia. The results from this aim will identify a neural marker(s) for meditation-related pain relief, a critical step in defining how meditation reduces pain.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Healthy research participants, trained to psychophysically rate their experience in response to a range of thermal stimuli, will be randomly assigned to one of two experimental groups (mindfulness meditation n=20 or deep-breathing meditation n=20). After receiving four twenty-minute meditation training sessions, participants will return for a final session of thermal testing while lying in the MRI scanner. Participants will be exposed to 4 blocks of testing, using thermal stimuli cycled between painful (49°C) and non-painful (35°C) temperatures for 6 minutes. Blood oxygen-level dependent imaging will be used to map the functional connectivity of brain regions in response to the thermal fluctuations. In the first two blocks participants will lie quietly with eyes closed. After a 10 minute rest, subjects will begin meditating and the thermal testing will resume.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Subjects will be randomly assigned to two groups by the research coordinator. Investigators, study staff and MRI technicians will be blind as to the participant's group assignment.
Primary Purpose: Basic Science
Official Title: Identifying the Neurofunctional Connections Supporting Mindfulness Meditation Based Analgesia
Actual Study Start Date : April 20, 2018
Actual Primary Completion Date : August 2, 2018
Actual Study Completion Date : August 2, 2018

Arm Intervention/treatment
Experimental: Mindfulness Meditation Group
Research volunteers will participate in four sessions (20 min/session) of mindfulness training. Participants are taught that perceived sensory events are "momentary" and "fleeting", requiring no further evaluation. They will be asked to close their eyes, relax and focus on the flow of their breathing by "simply letting go" of discursive thoughts.
Behavioral: Mindfulness Training
A well-validated brief mindfulness-based mental training regimen [four sessions; 20 min/session] will be used to teach patients to independently practice mindfulness meditation.
Other Name: mental training

Active Comparator: Book Listening Control
Study volunteers will listen to an audio recording of the Natural History of Selborne across each session.This 4 session sequence is meant to match features of the experimental meditation sessions, including attention to the recording, room setting, social support, conditioning, and time elapsed during the sessions. We do not expect that this group will demonstrate significant blood oxygenation changes as a function of the intervention.
Behavioral: Book Listening Control
Study volunteers will listen to four 20 minute blocks of The Natural History and Antiquities of Selborne throughout their interventions.
Other Name: mental training




Primary Outcome Measures :
  1. Blood oxygenation level dependent (BOLD) signaling [ Time Frame: Up to 3 weeks ]
    Changes in blood oxygenation levels to thermally noxious stimuli (49°C) will be assessed, and planned comparisons will be performed between subjects trained in mindfulness meditation and those trained in deep-breathing meditation.


Secondary Outcome Measures :
  1. Change in Visual Analog Scale Pain Ratings as a function of mindfulness-based mental training [ Time Frame: Up to 3 weeks ]

    The visual analog scale (VAS) measures pain ratings that will be assessed in response to noxious (49°C) thermal stimuli applied to the back of the right calf muscle.

    Pain intensity and pain unpleasantness ratings will be assessed with a Visual Analog Scale. The minimum rating ("0") is designated as "no pain" whereas the maximum ("10") is labeled as "most intense imaginable" or "most unpleasant imaginable". Higher values corresponded to higher perceived pain ratings.

    Baseline pain ratings will be assessed on session one and again at session six.



Other Outcome Measures:
  1. Respiration Rate [ Time Frame: Up to 3 weeks ]
    A respiratory transducer (TSD 201; Biopac Systems) will be placed around the chest to measure the paticipant's rate of respiration.

  2. Heart Rate [ Time Frame: up to 3 weeks ]
    Pulse oximeter (OXY-MRI-SPO2; Biopac Systems) will be placed on the left index finger to measure the paticipant's heart rate.

  3. State Anxiety Inventory (SAI) [ Time Frame: up to 3 weeks ]
    This inventory is a 20 question test used to measure a subject's state of anxiety. A numeric value between 1 (Not at all) and 4 (Very Much So) is provided in response to each statement. The range of scores for this test is between 20 and 80, with higher scores reflecting higher estimates of anxiety.

  4. Freiburg Mindfulness Inventory (FMI) [ Time Frame: up to 3 weeks ]
    The FMI is a 14 item measure of mindfulness. Each declarative statement is measured on a 4 point scale ranging from: 1 (Rarely) to 4 (Almost Always). A couple of the items are reverse scored. Higher scores reflect higher states of mindfulness.

  5. Beck's Depression Inventory (BDI) [ Time Frame: up to 3 weeks ]

    This a 21-item multiple choice self-report inventory used to measure the severity of depression. A score between 0 and 3 is applied to each question. Higher total scores indicate more severe depressive symptoms.

    0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression


  6. Multidimensional Iowa Suggestibility Scale (MISS) short form [ Time Frame: up to 3 weeks ]
    The MISS includes five suggestibility subscales (consumer, physiological, physiological reactivity, persuadability, and peer conformity) and two companion scales (unpersuadability and the short suggestibility scale). The five suggestibility subscales can be summed to give the suggestibility total score. Higher values equate to higher levels of suggestibility.

  7. Positive and Negative Affective Scale (PANAS) [ Time Frame: up to 3 weeks ]
    PANAS is composed of two mood scales, one that measures positive affect and the other which measures negative affect. It uses a 20 item test that employs a 5-point rating scale ranging from very slightly or not at all (1) to extremely so (5). Positive affect scores and negative affect scores are calculated separately by adding each group independently. For the positive items, higher scores represent higher levels of positive affect. For the negative items, lower scores represent lower levels of negative affect.

  8. Attitude Toward Treatment Inventory (ATTI) [ Time Frame: up to 3 weeks ]
    The ATTI is used to monitor a participant's impressions and attitudes about the interventions used in this study (i.e. mindfulness meditation). It supplies 5 multiple-choice questions answered on a 10 point scale, ranging from 0 (not logical) to 9 (very logical). Higher scores reflect more positive subject impressions about the therapeutic interventions.

  9. Pain Catastrophizing Scale (PCS) [ Time Frame: up to 3 weeks ]
    The PCS is a 13 item scale, with each item rated on a 5-point scale between: 0 (Not at all) and 4 (all the time). The PCS is broken into three subscales including: magnification, rumination, and helplessness. The total range of scores is between 0-52 with higher values reflecting more salient impacts of pain on one's day to day experience.

  10. Profile of Mood States (PoMS) Questionnaire [ Time Frame: up to 3 weeks ]
    The PoMS is a psychological rating scale used to assess transient and distinct mood states. The POMS measures six different dimensions of mood swings over a period of time. These include: Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment. A five-point scale ranging from "not at all" (0) to "extremely" (4) is provided for participants to rate their mood to 65 descriptive adjectives. A total mood disturbance (TMD) score is computed from adding all subscales. High scores reflect high mood disturbance.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal volunteers between ages 18 and 65.
  • Men and women of all races will be included

Exclusion Criteria:

  • Subjects with a history of psychiatric or neurological disorders.
  • Subjects will be excluded if they report being claustrophobic.
  • Subjects with a prior history of meditation training will be excluded.
  • Subjects with ferrous metal or electronic devices (e g., pacemakers) implanted in there body will be excluded.
  • Pregnant subjects will be excluded.
  • Subjects that demonstrate no pain to noxious temperatures (>49°C) or excessive responses to temperatures at or below 43°C will be excluded.

Information from the National Library of Medicine

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): NCT03414138


Locations
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United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
University of California, San Diego
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Fadel Zeidan, PhD Wake Forest University Health Sciences
Publications:
Borkovec TD, & Nau, S.D. Credibility of analogue therapy rationales. Journal of Behavior Therapy and Experimental Psychiatry 1972;3:257-260.
Kotov R, Bellman, S., & Watson, D. Multidimensional Iowa suggestibility scale: Brief Manual, 2007.
McNAir D, Loor, M., & Droppleman, L. Profile of Mood States. San Diego, CA: Educational and Industrial Testing Service, 1971.
Spielberger CD. Manual for the State-Trait Anxiety Inventory (STAI-form y). Palo Alto, CA: Consulting Psychology Press, 1983.
Walach H, Buchheld N, Buttenmuller V, Kleinknecht N, Schmidt S. Measuring mindfulness—the Freiburg Mindfulness Inventory (FMI). Personality and Individual Differences 2006;40:1543-1555.
White G. Natural History and Antiquities of Selborne. London, England: Cassell and Company, 1908.
Zeidan F. The Neurobiology of Mindfulness Meditation. In: KW Brown, Creswell, J.D., & R.M., Ryan, editor. Handbook of Mindfulness Science: Theory, Research and Practice. New York, New York: The Guilford Press, 2015.

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Responsible Party: Fadel Zeidan, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03414138    
Other Study ID Numbers: IRB00040373
4R00AT008238-03 ( U.S. NIH Grant/Contract )
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fadel Zeidan, University of California, San Diego:
Pain
Mindfulness
Meditation
fMRI