Brain Mechanisms Supporting Meditation-based Analgesia

Sponsor

University of California, San Diego (Other)

Overall Status

Completed

CT.gov ID

NCT03414138

Collaborator

National Center for Complementary and Integrative Health (NCCIH) (NIH)

Enrollment

Location

Arms

3.4

Actual Duration (Months)

11.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

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.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 :

Apr 20, 2018

Actual Primary Completion Date :

Aug 2, 2018

Actual Study Completion Date :

Aug 2, 2018

Arms and Interventions

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 Names: 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 Names: mental training

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 Names:

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 Names:

mental training

Outcome Measures

Primary Outcome Measures

Blood oxygenation level dependent (BOLD) signaling [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

Change in Visual Analog Scale Pain Ratings as a function of mindfulness-based mental training [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

Respiration Rate [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.
Heart Rate [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.
State Anxiety Inventory (SAI) [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.
Freiburg Mindfulness Inventory (FMI) [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.
Beck's Depression Inventory (BDI) [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
Multidimensional Iowa Suggestibility Scale (MISS) short form [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.
Positive and Negative Affective Scale (PANAS) [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.
Attitude Toward Treatment Inventory (ATTI) [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.
Pain Catastrophizing Scale (PCS) [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.
Profile of Mood States (PoMS) Questionnaire [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Principal Investigator: Fadel Zeidan, PhD, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Fadel Zeidan, Assistant Professor, University of California, San Diego

ClinicalTrials.gov Identifier:

NCT03414138

Other Study ID Numbers:

IRB00040373
4R00AT008238-03

First Posted:

Jan 29, 2018

Last Update Posted:

Jun 11, 2019

Last Verified:

Jun 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fadel Zeidan, Assistant Professor, University of California, San Diego

Study Results

No Results Posted as of Jun 11, 2019