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Trial record 10 of 16 for:    +yoga+arthritis

Mindfulness Based Stress Reduction in Rheumatic Diseases (MBSR)

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ClinicalTrials.gov Identifier: NCT03411057
Recruitment Status : Enrolling by invitation
First Posted : January 25, 2018
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Psoriatic Arthritis Scleroderma Behavioral: Mindfulness Based Stress Reduction (MBSR) Other: Control

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.


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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mindfulness Based Stress Reduction in Rheumatic Diseases
Actual Study Start Date : January 18, 2018
Estimated Primary Completion Date : January 18, 2020
Estimated Study Completion Date : January 18, 2021


Group/Cohort Intervention/treatment
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.
Behavioral: Mindfulness Based Stress Reduction (MBSR)
An interactive form of meditation that includes gentle yoga.

Control
Rheumatoid Arthritis, Psoriatic Arthritis, and scleroderma participants in this group will watch an educational stress reduction video (10 minutes).
Other: Control
Standard of care including an educational video.




Primary Outcome Measures :
  1. Change in anxiety [ Time Frame: Baseline, midcourse (approximately 4 weeks), post course (approximately 8-12 weeks) ]
    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.

  2. Change in Self-Efficacy (Symptoms) [ Time Frame: Baseline, midcourse (approximately 4 weeks), post course (approximately 8-12 weeks) ]
    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.

  3. Change in Self-Efficacy (Emotions) [ Time Frame: Baseline, midcourse (approximately 4 weeks), post course (approximately 8-12 weeks) ]
    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.


Secondary Outcome Measures :
  1. Change in Clinical Disease Activity Index (CDAI) [ Time Frame: Baseline and post course (approximately 8-12 weeks) ]
    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.

  2. Change in C-Reactive Protein (CRP) [ Time Frame: Baseline and post course (approximately 8-12 weeks) ]
    A value of 0-0.5 mg/dL indicates a normal range. Values greater 0.5 mg/dL indicate elevated degrees of inflammation.

  3. Change in Medsger Disease Severity Score (Composite Measure of Scleroderma Disease Activity) [ Time Frame: Baseline and post course (approximately 8-12 weeks) ]
    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).


Biospecimen Retention:   Samples Without DNA
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).


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Established patients of the Johns Hopkins Arthritis and Scleroderma Centers
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03411057


Locations
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United States, Maryland
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Clifton O Bingham, MD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03411057     History of Changes
Other Study ID Numbers: IRB00147638
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
Mindfulness
Mindfulness Based Stress Reduction
Rheumatoid Arthritis
Anxiety
Depression
Psoriatic Arthritis
scleroderma

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Arthritis, Psoriatic
Scleroderma, Systemic
Scleroderma, Diffuse
Rheumatic Diseases
Collagen Diseases
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases