Mindfulness Based Stress Reduction in Rheumatic Diseases
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Arthritis, Psoriasis, Rheumatoid Arthritis, Skin and Soft Tissue Infections, Dermatology, Dermatology, Rheumatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 1/9/2019 |
| Start Date: | January 18, 2018 |
| End Date: | January 18, 2021 |
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.
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.
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.
Inclusion Criteria:
- Established patients in the Johns Hopkins Bayview Rheumatology clinic
- Rheumatoid Arthritis per the American College of Rheumatology (ACR) and European
League Against Rheumatism (EULAR) 2010 classification criteria
- Psoriatic Arthritis per the Classification Criteria for Psoriatic Arthritis (CASPAR)
or physician-diagnosis
- Scleroderma per the ACR/EULAR 2013 classification criteria or physician-diagnosis
- New onset of Comorbid anxiety and/or depression
- Participants must speak English
- Participants must be able to attend a weekly (8 weeks total) Mindfulness Based Stress
Reduction course as well as routine follow up appointments in the rheumatology clinic
- Participants must have insurance
Exclusion Criteria:
- Patients who routinely perform mindfulness based practices and any other form of
meditation, including moving meditations such as yoga
- Patients who are not physically able to sit through weekly sessions that are 2.5 hours
in length or a final meditative retreat of 4-hours duration
- Patients with alcohol or substance use disorders within the past 6 months
- Current, or previous history of psychotic disorders or bipolar disorder
- Patients who are actively suicidal
- Patients on greater than 10 mg of prednisone daily on a chronic basis.
We found this trial at
1
site
Click here to add this to my saved trials
