Clinical Trial Finder

Mindfulness Based Stress Reduction in Rheumatic Diseases

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03411057
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Johns Hopkins University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Dana DiRenzo, MD
Principal Investigator Affiliation Johns Hopkins University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Rheumatoid Arthritis, Psoriatic Arthritis, Scleroderma
Additional Details

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.

Arms & Interventions

Arms

: 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).

Interventions

Behavioral: - Mindfulness Based Stress Reduction (MBSR)

An interactive form of meditation that includes gentle yoga.

Other: - Control

Standard of care including an educational video.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Johns Hopkins Asthma and Allergy Center, Baltimore, Maryland

Status

Address

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, 21224

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