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| ID | Type | Description | Link |
|---|---|---|---|
| R61AT010134 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| University of Maryland, Baltimore | OTHER |
| University of California, San Diego | OTHER |
| University of Utah |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Campbell, Ph.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21224 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Meditation Group A-Savoring | A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding). Meditation Intervention A: This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding. Participants in the Savoring Meditation Condition were trained to generate positive emotions through savoring a positive autobiographical memory in a multi-sensory manner. |
| FG001 | Meditation Group B-Breathing | A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding). Meditation Intervention B: This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding. Participants in the Breathing Meditation condition were trained to relax the body and take deep breaths in a self-directed manner. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Measured at the post-Intervention time point during an MRI scan, approximately 60 minutes. |
|
Adverse event data were collected over the duration of the study, approximately 4-6 weeks per participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Meditation Group A-Savoring | A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding). Meditation Intervention A: This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding. Participants in the Savoring Meditation Condition were trained to generate positive emotions through savoring a positive autobiographical memory in a multi-sensory manner. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Patrick Finan | University of Virginia | (720) 244-1702 | tpx4xe@virginia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 28, 2022 | Feb 10, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| OTHER |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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| 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. |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Meditation Group B | A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding). Meditation Intervention B: This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding. |
|
| 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. | Posted | Mean | Standard Deviation | ml/100g/min | Measured at the post-Intervention time point during an MRI scan, approximately 60 minutes |
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|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Meditation Group B-Breathing | A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding). Meditation Intervention B: This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding. Participants in the Breathing Meditation condition were trained to relax the body and take deep breaths in a self-directed manner. | 0 | 23 | 0 | 23 | 0 | 23 |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |