Mindfulness Based Stress Reduction in Rheumatic Diseases (MBSR)

April 22, 2021 updated by: Johns Hopkins University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Asthma and Allergy Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 96 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Established patients of the Johns Hopkins Arthritis and Scleroderma Centers

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, midcourse (approximately 4 weeks), post course (approximately 8-12 weeks)
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.
Baseline, midcourse (approximately 4 weeks), post course (approximately 8-12 weeks)
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.
Baseline, midcourse (approximately 4 weeks), post course (approximately 8-12 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and post course (approximately 8-12 weeks)
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.
Baseline and post course (approximately 8-12 weeks)
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).
Baseline and post course (approximately 8-12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dana DiRenzo, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 22, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 22, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00147638

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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