Meditation Effects on Brain Function in Rheumatoid Arthritis

NCT03975595 | Completed Results DMC

• 2 other identifiers: IRB00192687R61AT010134
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• 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.

  Measured at the post-Intervention time point during an MRI scan, approximately 60 minutes.

• 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.

  Measured at the post-Intervention time point during an MRI scan, approximately 60 minutes

Study Arms (2)

Meditation Group A

ACTIVE COMPARATOR

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.

Behavioral: Meditation Intervention A

Meditation Group B

ACTIVE COMPARATOR

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.

Behavioral: Meditation Intervention B

Interventions

Meditation Intervention A BEHAVIORAL

This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.

Meditation Group A

Meditation Intervention B BEHAVIORAL

This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.

Meditation Group B

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Withheld to preserve recruitment integrity.

You may not qualify if:

• Withheld to preserve recruitment integrity.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institutes of Health (NIH): collaborator
• University of Maryland, Baltimore: collaborator
• University of California, San Diego: collaborator
• University of Utah: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Patrick Finan
• Organization: University of Virginia

tpx4xe@virginia.edu

(720) 244-1702

Study Officials

• Claudia Campbell, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 5, 2019
• Study Start: October 7, 2019
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: March 9, 2023
• Results First Posted: March 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)