Rheumatoid Arthritis
Conditions
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.
Interventions
BEHAVIORALMeditation Intervention A
This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.
BEHAVIORALMeditation Intervention B
This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.
Sponsors
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)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Withheld to preserve recruitment integrity.
Exclusion criteria
* Withheld to preserve recruitment integrity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Meditation Group 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.
Meditation Intervention A: This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding. | 21 |
| Meditation Group 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 Intervention B: This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding. | 23 |
| Total | 44 |
Baseline characteristics
| Characteristic | Meditation Group A | Meditation Group B | Total |
|---|---|---|---|
| Age, Continuous | 50.7 years STANDARD_DEVIATION 12 | 49.8 years STANDARD_DEVIATION 10.9 | 50.2 years STANDARD_DEVIATION 11.3 |
| Race/Ethnicity, Customized Race Asian | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Black or African American | 5 Participants | 5 Participants | 10 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Race White or European American | 13 Participants | 13 Participants | 26 Participants |
| Region of Enrollment United States | 21 Participants | 23 Participants | 44 Participants |
| Sex: Female, Male Female | 20 Participants | 21 Participants | 41 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 23 |
| other Total, other adverse events | 0 / 21 | 0 / 23 |
| serious Total, serious adverse events | 0 / 21 | 0 / 23 |
Outcome results
Primary
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.
Time frame: Measured at the post-Intervention time point during an MRI scan, approximately 60 minutes.
Population: This outcome was not assessed because it was intended for comparison with a treatment arm (mindful breathing) that was dropped from the study due to COVID-19 delays. No data was collected.
Primary
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.
Time frame: Measured at the post-Intervention time point during an MRI scan, approximately 60 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation Group A | Nucleus Accumbens Activation | 16153.59 ml/100g/min | Standard Deviation 1309.9 |
| Meditation Group B | Nucleus Accumbens Activation | 15834.56 ml/100g/min | Standard Deviation 1681.54 |