MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms

NCT03514355 | Completed

• 1 other identifier: MP-31-2017-1558
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Despite their efficacy at controlling joint inflammation, current treatments of rheumatoid arthritis (RA) leave up to 40% of patients into non-remission. Non-remission is most frequently due to persistently negative self-reported global impact of RA, and not to remaining swollen joints or elevated levels of acute phase reactants. In a cohort of recent-onset RA patients diagnosed early and treated to remission (Sherbrooke Early Undifferentiated PolyArthritis (EUPA) cohort), treatment of active disease rapidly led to reduced depressive symptoms in most, but 20% still expressed elevated depressive symptoms (using the CES-D screening tool) after a mean of 7 months. Elevated CES-D scores at this early time strongly predicted never reaching remission over the following 4 years. Elevated CES-D scores were strongly correlated with increased levels of patient-related outcomes (PROs such as fatigue, pain, sleep quality, stiffness and functional limitation), but not with joint or systemic inflammation. In fact, 80% of patients expressing depressive symptoms had controlled joint disease at the same visit. The investigators propose that addressing depressive symptoms will improve RA patients' symptoms and quality of life. In clinical practice, the best indicator of depressive symptoms is the presence of a disconnect between the Patient's (Pt-VAS) and the Physician's (MD-VAS) evaluation of disease activity in patients without objective signs of inflammation. This pilot study will explore the feasibility and acceptability of testing MBSR in these patients. It will assess over 6 months the changes in depressive symptoms and PROs both in controls and MBSR-treated patients. If positive, the investigators plan to complete a multicenter 6-month Randomized Clinical trial (RCT) (with a 2 year follow up) to formally address the risks/benefits of group MBSR interventions in RA patients with controlled inflammatory disease but positive disconnect between Pt-VAS and MD-VAS.

Conditions

Rheumatoid Arthritis; Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

• Spontaneous variation in Center for Evaluation Studies - Depression (CES-D) score in controls

  to estimate the variations in CES-D scores (range 0-60; depression suggested if at least 16) between baseline and 6 months (i.e. about 3 months after the end of MBSR) in the randomized controls

  6 months

Secondary Outcomes (9)

• Numbers of patients recruited using current recruitment strategy

  6 months

• Impact of Mindfulness-Based Stress Reduction (MBSR) on Patient evaluation of disease activity of Rheumatoid arthritis

  6 months

• Impact of Mindfulness-Based Stress Reduction (MBSR) on Center for Epidemiologic Studies Depression Scale Revised (CES-D) depressive symptoms)

  6 months

• Impact of MBSR on anxiety

  6 months

• Impact of MBSR on pain

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Mindfulness-Based Stress Reduction (MBSR) is a program intended to draw upon the group's shared experiences to facilitate the development of mindfulness. MBSR is offered in 2.5-h classes on a weekly basis for 8 consecutive weeks, with a retreat day in between classes 6 and 7. This day involves guided meditations, allowing for continuity in practice. Classes include specific exercises (e.g. identifying thoughts, emotions and body sensations associated with illness); these are then extended as homework and discussed in the subsequent class. The curriculum themes and content are arranged week by week to reflect these principles.

Behavioral: Mindfulness-Based Stress Reduction

Control

NO INTERVENTION

The control group will receive usual care, with no treatment restrictions. Treating physicians will be informed of CES-D results. Patients will be asked to fulfill the same clinical assessment and questionnaires, and to provide the same biosamples than those patients in the intervention.

Interventions

Mindfulness-Based Stress Reduction BEHAVIORAL

8 weekly 2.5 h sessions plus one day of practice

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years, with stable (3 months) disease modifying antirheumatic drugs (DMARDs) and/or biologic-treated RA (meeting classification criteria)
• both ≤2/66 SJC plus CRP ≤8 mg/L
• Patient Evaluation of disease activity (Pt-VAS) ≥20 higher than Physician Evaluation of Disease Activity (MD-VAS).

You may not qualify if:

• Inability to consent (e.g. not fluent in French, dementia) or to participate in groups;
• Active vasculitis, SJC ≥3, CRP ≥8, arthritis drug changes (i.e. addition or increase of DMARDs or biologics or oral corticosteroids) during the last 3 months

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Canadian Initiative for Outcomes in Rheumatology Care: collaborator

Study Sites (1)

Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Estrie - CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; 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; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Gilles Boire, MD, MSc

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Rheumatologist

Model Details: Randomization of consenting eligible patients in intervention and control groups using separate permutated random blocks of 4

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: May 2, 2018
• Study Start: September 4, 2017
• Primary Completion: December 10, 2019
• Study Completion: September 29, 2021
• Last Updated: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)