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Meditation Effects on Brain Function in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meditation Intervention A
Meditation Intervention B
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Rheumatoid Arthritis

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Withheld to preserve recruitment integrity.

Exclusion Criteria:

  • Withheld to preserve recruitment integrity.

Sites / Locations

  • Johns Hopkins University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Meditation Group A

Meditation Group B

Arm Description

A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding). Meditation Group A is the Savoring Meditation Condition. Participants in this condition were trained to generate positive emotions through savoring a pleasant autobiographical memory in a multi-sensory manner.

A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding). Meditation Group B is the Breathing Meditation Condition. Participants in this condition were trained to relax and body and take deep breaths in a self-directed manner.

Outcomes

Primary Outcome Measures

Lateral Orbital Frontal Cortex Activation
Activation in the Lateral Orbital Frontal Cortex will be quantitatively measured as the difference in cerebral blood flow (CBF) response during noxious thermal stimulation while participants actively practice Intervention A in the scanner, compared to the CBF response during noxious thermal stimulation while participants rest. The unit of measure will be milliliter per 100 gram brain tissue per minute.
Nucleus Accumbens Activation
Activation in the Nucleus Accumbens will be quantitatively measured as the difference in cerebral blood flow (CBF) response during noxious thermal stimulation while participants actively practice Intervention B in the scanner, compared to the CBF response during noxious thermal stimulation while participants rest. The unit of measure will be milliliter per 100 gram brain tissue per minute (ml/100g/min). There is no normal range for this measure.

Secondary Outcome Measures

Full Information

First Posted
May 30, 2019
Last Updated
February 10, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institutes of Health (NIH), University of Maryland, Baltimore, University of California, San Diego, University of Utah, National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03975595
Brief Title
Meditation Effects on Brain Function in Rheumatoid Arthritis
Official Title
Meditation Effects on Brain Function in Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 7, 2019 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institutes of Health (NIH), University of Maryland, Baltimore, University of California, San Diego, University of Utah, National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the neural mechanisms supporting meditation-based pain relief in rheumatoid arthritis (RA) patients. The scientific premise is that RA patients' use of different meditation practices during noxious thermal stimulation will alter neural function in brain areas associated with pain, evaluation, and emotional appraisal. The investigators will randomize RA patients to a brief 4-session course of Intervention A (n=20) or Intervention B (n=20). At post-intervention, participants will undergo functional MRI (fMRI) using a perfusion-based arterial spin labeling (ASL) technique during noxious thermal stimulation to determine if the meditation practices differentially alter neural function during noxious thermal stimulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meditation Group A
Arm Type
Active Comparator
Arm Description
A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding). Meditation Group A is the Savoring Meditation Condition. Participants in this condition were trained to generate positive emotions through savoring a pleasant autobiographical memory in a multi-sensory manner.
Arm Title
Meditation Group B
Arm Type
Active Comparator
Arm Description
A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding). Meditation Group B is the Breathing Meditation Condition. Participants in this condition were trained to relax and body and take deep breaths in a self-directed manner.
Intervention Type
Behavioral
Intervention Name(s)
Meditation Intervention A
Intervention Description
This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.
Intervention Type
Behavioral
Intervention Name(s)
Meditation Intervention B
Intervention Description
This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.
Primary Outcome Measure Information:
Title
Lateral Orbital Frontal Cortex Activation
Description
Activation in the Lateral Orbital Frontal Cortex will be quantitatively measured as the difference in cerebral blood flow (CBF) response during noxious thermal stimulation while participants actively practice Intervention A in the scanner, compared to the CBF response during noxious thermal stimulation while participants rest. The unit of measure will be milliliter per 100 gram brain tissue per minute.
Time Frame
Measured at the post-Intervention time point during an MRI scan, approximately 60 minutes.
Title
Nucleus Accumbens Activation
Description
Activation in the Nucleus Accumbens will be quantitatively measured as the difference in cerebral blood flow (CBF) response during noxious thermal stimulation while participants actively practice Intervention B in the scanner, compared to the CBF response during noxious thermal stimulation while participants rest. The unit of measure will be milliliter per 100 gram brain tissue per minute (ml/100g/min). There is no normal range for this measure.
Time Frame
Measured at the post-Intervention time point during an MRI scan, approximately 60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Withheld to preserve recruitment integrity. Exclusion Criteria: Withheld to preserve recruitment integrity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Campbell, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Meditation Effects on Brain Function in Rheumatoid Arthritis

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