Meditation Effects on Brain Function in Rheumatoid Arthritis

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Behavioral: Meditation Intervention B; Behavioral: Meditation Intervention A

• Registration Number: NCT03975595
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-30
• Study First Submitted QC: 2019-06-03
• Study First Posted: 2019-06-05
• Study Start: 2019-10-07
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Status Verified: 2023-02
• Results First Submitted: 2023-02-10
• Results First Submitted QC: 2023-02-10
• Last Update Submitted: 2023-02-10
• Results First Posted: 2023-03-09
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Withheld to preserve recruitment integrity.

Exclusion Criteria

• Withheld to preserve recruitment integrity.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Meditation Group B	Meditation Intervention B	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.
Meditation Group A	Meditation Intervention A	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.

Primary Outcome Measures

Name	Time	Method
Lateral Orbital Frontal Cortex Activation	Measured at the post-Intervention time point during an MRI scan, approximately 60 minutes.	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	Measured at the post-Intervention time point during an MRI scan, approximately 60 minutes	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.

Trial Locations

Locations (1)

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States