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This study will assess the mental health and clinical benefits of Mindfulness Based Stress Reduction (MBSR) in patients with rheumatic disease who have anxiety or depression. MBSR, an interactive form of meditation that includes gentle yoga, will be taught by a certified instructor over an eight-week period. Mental health surveys will be conducted within one month of the study start and end as well as mid-course. Clinical assessments will be conducted within one-month of the study start and end.
Participation in the study entails completing a baseline and 1-month post MBSR follow up research appointment. A baseline research appointment must occur within 30 days (+/- 15 days) of the MBSR start. The 1 month follow up appointment must be completed within 30 days (+/- 15 days) after the MBSR course end. At each research appointment, disease activity, patient reported outcome measures (PROMs), and blood will be collected for future analysis. Patients will also be asked to complete the PROMs through an online survey platform using email, at MBSR course start, week 4 of the MBSR course, and at MBSR course end. Participants in the MBSR arm will also be recommended to perform self-directed meditation for 20-40 minutes per day, on off-days, throughout the 8-week session, as is typical for the MBSR course. Compliance with home meditation will be recorded on a take-home "practice" sheet that will be collected each week during the MBSR course.
If patients do not wish to participate in the MBSR course but are willing to participate in the study as a control, patients may also be consented. Controls will be asked to attend a baseline and 3-month research appointment where disease activity, PROMs, and blood donation would be obtained. Participants will also be asked to fill out PROMs (online) at 4 weeks. If a patient does not wish to participate in either arm of the MBSR study, patient will continue with routine psychological care for patient's anxiety and depression.
Blood samples will be collected at the baseline research appointment and the follow up research appointment, if the patient is willing. These samples will be drawn and banked for future analysis of inflammatory markers and cytokine expression.
Participants will be sent a health care usage survey after 3 months (coinciding with research visit 2; 1 month post-MBSR research visit or 3-month follow up research visit if control). Health care usage will continue to be screened for up to 1 year post research visit 1 via the electronic medical record.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) | Inflammatory Arthritis (Rheumatoid Arthritis, Psoriatic Arthritis) and scleroderma participants in this group will attend an 8 week MBSR course. The MBSR course meets once per week for 2.5 hours with a 4-hour retreat on week 8. |
| |
| Control | Rheumatoid Arthritis, Psoriatic Arthritis, and scleroderma participants in this group will watch an educational stress reduction video (10 minutes). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) | Behavioral | An interactive form of meditation that includes gentle yoga. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety | Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale (8a). The PROMIS Anxiety Scale is measured as a t score with a t-score range from 41 (less anxious) to 80 (highly anxious). For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10. | Baseline, midcourse (approximately 4 weeks), post course (approximately 8-12 weeks) |
| Change in Self-Efficacy (Symptoms) | Patient Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy Scale 8a. The PROMIS Self-Efficacy (Symptoms) Scale is measured as a t score with a t-score range from 41 (less efficacious) to 80 (highly efficacious). For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10. | Baseline, midcourse (approximately 4 weeks), post course (approximately 8-12 weeks) |
| Change in Self-Efficacy (Emotions) | Patient Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy Scale 8a. The PROMIS Self-Efficacy (Symptoms) Scale is measured as a t score with a t-score range from 41 (less efficacious) to 80 (highly efficacious). For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10. | Baseline, midcourse (approximately 4 weeks), post course (approximately 8-12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Disease Activity Index (CDAI) | The CDAI is calculated by the formula, CDAI = swollen joint count (28 sites) + tender joint count (28 sites) + patient global assessment (0-10; 10= severe) + evaluator global assessment (0-10; 10=severe). The total range is 0 to 76. Higher scores indicate more severe disease activity. Remission is considered less than 2.8, mild disease 2.8 to 10, moderate disease 10 to 22, and severe disease greater than 22. |
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Inclusion Criteria:
Exclusion Criteria:
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Established patients of the Johns Hopkins Arthritis and Scleroderma Centers
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| Name | Affiliation | Role |
|---|---|---|
| Dana DiRenzo, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Asthma and Allergy Center | Baltimore | Maryland | 21224 | United States |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D015535 | Arthritis, Psoriatic |
| D045743 | Scleroderma, Diffuse |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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Serum will be collected at research visits within one-month the Mindfulness Based Stress Reduction (MBSR) course start and end. Serum will be used to analyze levels of C-Reactive Protein (CRP) and pro-inflammatory cytokines (Mesoscale 4-plex pro-inflammatory panel 1).
| Control | Other | Standard of care including an educational video. |
|
| Baseline and post course (approximately 8-12 weeks) |
| Change in C-Reactive Protein (CRP) | A value of 0-0.5 mg/dL indicates a normal range. Values greater 0.5 mg/dL indicate elevated degrees of inflammation. | Baseline and post course (approximately 8-12 weeks) |
| Change in Medsger Disease Severity Score (Composite Measure of Scleroderma Disease Activity) | The Medsger Severity Score is a composite measure for scleroderma disease activity comprised of the following sub-domains: general, peripheral vascular, skin, join/tendon, muscle, GI tract, lung, heart, kidney. Each sub-domain ranges from 0-4 (4=worse). The total Medsger Disease Severity Score is a sum of the subdomains and ranges from 0-36 (36= worse). | Baseline and post course (approximately 8-12 weeks) |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D012595 | Scleroderma, Systemic |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D004191 |
| Behavioral Disciplines and Activities |