Clinical trial NCT03411057: Mindfulness Based Stress Reduction in Rheumatic Diseases
Official title: Mindfulness Based Stress Reduction in Rheumatic Diseases
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Scleroderma
Keywords: Mindfulness
Mindfulness Based Stress Reduction
Rheumatoid Arthritis
Anxiety
Depression
Psoriatic Arthritis
scleroderma
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Established patients of the Johns Hopkins Arthritis and Scleroderma Centers

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in anxiety
timeFrame: Baseline, midcourse (approximately 4 weeks), post course (approximately 8-12 weeks)
measure: Change in Self-Efficacy (Symptoms)
timeFrame: Baseline, midcourse (approximately 4 weeks), post course (approximately 8-12 weeks)
measure: Change in Self-Efficacy (Emotions)
timeFrame: Baseline, midcourse (approximately 4 weeks), post course (approximately 8-12 weeks)
Secondary outcomes:
measure: Change in Clinical Disease Activity Index (CDAI)
timeFrame: Baseline and post course (approximately 8-12 weeks)
measure: Change in C-Reactive Protein (CRP)
timeFrame: Baseline and post course (approximately 8-12 weeks)
measure: Change in Medsger Disease Severity Score (Composite Measure of Scleroderma Disease Activity)
timeFrame: Baseline and post course (approximately 8-12 weeks)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Asthma and Allergy Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Dana DiRenzo, MD
role: PRINCIPAL_INVESTIGATOR
References: