Mindfulness Based Stress Reduction in Rheumatic Diseases

NCT03411057 | Terminated

• 1 other identifier: IRB00147638
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis; Scleroderma

Keywords

Mindfulness; Mindfulness Based Stress Reduction; Rheumatoid Arthritis; Anxiety; Depression; Psoriatic Arthritis; scleroderma

Outcome Measures

Primary Outcomes (3)

• Change in anxiety

  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)

  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)

  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 Outcomes (3)

• Change in Clinical Disease Activity Index (CDAI)

  Baseline and post course (approximately 8-12 weeks)

• Change in C-Reactive Protein (CRP)

  Baseline and post course (approximately 8-12 weeks)

• Change in Medsger Disease Severity Score (Composite Measure of Scleroderma Disease Activity)

  Baseline and post course (approximately 8-12 weeks)

Study Arms (2)

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)

Control

Rheumatoid Arthritis, Psoriatic Arthritis, and scleroderma participants in this group will watch an educational stress reduction video (10 minutes).

Other: Control

Interventions

Mindfulness Based Stress Reduction (MBSR) BEHAVIORAL

An interactive form of meditation that includes gentle yoga.

Mindfulness Based Stress Reduction (MBSR)

Control OTHER

Standard of care including an educational video.

Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Established patients of the Johns Hopkins Arthritis and Scleroderma Centers

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, 21224, United States

Location

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).

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Scleroderma, Diffuse; Anxiety Disorders; Depression

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Scleroderma, Systemic; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Dana DiRenzo, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: January 25, 2018
• Study Start: January 18, 2018
• Primary Completion: April 22, 2021
• Study Completion: April 22, 2021
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)