Rheumatoid ArthritisPARIS-DNCT03514355
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
A study testing Mindfulness-Based Stress Reduction in people with Rheumatoid Arthritis and Depressive Symptoms, run by Université de Sherbrooke at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Depressive Symptoms
- What is being tested?
- Mindfulness-Based Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- 4 Sep 2017to 29 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Estrie - CHUS
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: Pilot Study of Mindfulness-Based Stress Reduction (MBSR) in Patients With Rheumatoid Arthritis That Still Screen Depressed, Despite Adequate Control of Inflammation
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.
Read the detailed description
This is a pilot project for a pragmatic multisite, 6-month, two arm RCT of an MBSR intervention in RA patients expressing depressive symptoms despite controlled joint inflammation, on measures of depressive symptoms (Primary outcome). The investigators will also explore the impact of MBSR on significant PROs (e.g. fatigue, pain, Pt-VAS, anxiety) further translating into lower SDAI scores post-MBSR, and the feasibility of determining if improvement may be mediated though better adherence to treatment and/or through a modification of inflammation-related biomarkers.
During the present 1-year pilot study, the investigators propose to randomize 50 patients, and offer 2 MBSR groups of ≈13 patients each. Due to the bidirectional relationship between RA and depression, MBSR will be studied in patients receiving stable doses of arthritis medications during remission or low disease activity. To avoid recruitment based on thresholds of composite scores (e.g. SDAI) that are strongly impacted by depression-sensitive variables, such as Patient global evaluation of disease activity (PtVAS) and tender joint counts (TJC), the investigators will use a Swollen Joint Count (SJC) ≤2 out of 66 joints and C-Reactive Protein (CRP) ≤8 mg/L ('objective' measures) to define controlled disease. As SJC is the major determinant for RA treatment change in clinical practice, short-term RA treatment changes are unlikely in the recruited patients.
Controlled RA patients reporting Pt-VAS superior to MD-VAS by at least 20/100 units will be recruited. Blinded clinical assessors will determine the joint counts and the Examiner global evaluation of disease activity (EVAS) to determine SDAI scores at baseline and at 6 months. The French Canadian version of the CES-D and the Beck Depression Inventory to assess the importance of depressive symptoms, as well as 0-100 VAS scales (fatigue; sleep; pain; PtVAS) and Health Assessment Questionnaire (HAQ) will be obtained at both visits. Reporting will conform to the CONSORT recommendations for pilot studies.
This study reflects clinical practice, where there is heterogeneity in duration of disease, gender, age, type and dose of RA drugs used, as well as type and dose of antidepressants (when used). While the investigators suggest that RA drugs remain constant over the 6-month intervention period, treating physicians will be free to modify treatment if clinically indicated. Antidepressant use will not be an exclusion criterion.
For pragmatic reasons (e.g. uneven availability and expertise of primary care physician's (PCP), unknown effect size of the intervention), the investigators will not include a second active treatment arm with optimization of antidepressants. Instead, the investigators will inform in writing treating PCPs of their patient participation to the study and of the disconnect between Pt-VAS and MD-VAS. Changes to arthritis and depression drugs will be tracked and controlled for in analyses. For patients' safety, psychological contraindications to MBSR will be screened at baseline during a phone interview by Dr Françoise Gendron who will direct the MBSR sessions, and patients with contraindications excluded.
- Conditions
- Rheumatoid Arthritis, Depressive Symptoms
- Being tested
- Mindfulness-Based Stress Reduction
- Medical subject headings
- Arthritis, Rheumatoid, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress ReductionBehavioural
8 weekly 2.5 h sessions plus one day of practice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (9)
Numbers of patients recruited using current recruitment strategy
adjust recruitment strategy to obtain an optimal one, that is being able to form randomized groups of 15 patients in the MBSR group and 15 controls, every 6 months over 12 months
Measured: 6 months
Impact of Mindfulness-Based Stress Reduction (MBSR) on Patient evaluation of disease activity of Rheumatoid arthritis
to estimate the impact of MBSR on Patient evaluation of disease activity of Rheumatoid arthritis (range 0-10, 0 meaning no disease activity and 10 the most active disease possible according to the patient) between baseline and 6 months following MBSR
Measured: 6 months
Impact of Mindfulness-Based Stress Reduction (MBSR) on Center for Epidemiologic Studies Depression Scale Revised (CES-D) depressive symptoms)
to estimate the impact of MBSR on Center for Epidemiologic Studies Depression Scale Revised between baseline and 6 months following MBSR. The scale goes from 0 to 60 (60 meaning the maximal depressive symptoms possible). An individual from the general population with a score above 16 is considered with possible depression and a clinical assessment for depression may be justified; the equivalent threshold in patients with rheumatoid arthritis is 19.
Measured: 6 months
Impact of MBSR on anxiety
estimate impact of MBSR (versus control) between baseline and 6 months on anxiety measured using the Generalized Anxiety Disorder-7 (GAD-7 scale from 0 to 21, 21 being the worst possible score)
Measured: 6 months
Impact of MBSR on pain
estimate impact of MBSR (versus control) between baseline and 6 months on pain (Visual Analog Scale goes from 0-100, with 100 indicating the most severe possible pain)
Measured: 6 months
Impact of MBSR on fatigue
estimate impact of MBSR (versus control) between baseline and 6 months on fatigue (Visual Analog Scale goes from 0 to100, with 100 indicating the most severe fatigue possible)
Measured: 6 months
Beck Depression Inventory (BDI)
Impact of MBSR (versus control) between baseline and 6 months on BDI scores (range 0-63, 63 being the worst possible score)
Measured: 6 months
Numbers of patients with complete Biomarker collection
validate our methods of biomarker collection to attain more than 90% of usable samples
Measured: 6 months
Numbers of patients with adverse events linked to MBSR
track adverse events associated with MBSR in RA patients according to CTCAE v4.03
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start4 Sep 2017
- Primary completion10 Dec 2019
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization of consenting eligible patients in intervention and control groups using separate permutated random blocks of 4
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Initiative for Outcomes in Rheumatology Care
- Responsible party
- Principal investigator, Gilles Boire, Université de Sherbrooke
- Investigators
- Gilles Boire, MD, MSc, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514355
- Sponsor's protocol ID
- MP-31-2017-1558
- Acronym
- PARIS-D
- Status last verified
- Sep 2021
- First submitted
- 18 Aug 2017
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Mindfulness-Based Stress Reduction (MBSR) in Patients With Rheumatoid Arthritis That Still Screen Depressed, Despite Adequate Control of Inflammation
- ClinicalTrials.gov ID
- NCT03514355
- Acronym / sponsor ID
- PARIS-D / MP-31-2017-1558
- Conditions
- Rheumatoid Arthritis, Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Canadian Initiative for Outcomes in Rheumatology Care
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 2 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a pilot project for a pragmatic multisite, 6-month, two arm RCT of an MBSR intervention in RA patients expressing depressive symptoms despite controlled joint inflammation, on measures of depressive symptoms (Primary outcome). The investigators will also explore the impact of MBSR on significant PROs (e.g. fatigue, pain, Pt-VAS, anxiety) further translating into lower SDAI scores post-MBSR, and the feasibility of determining if improvement may be mediated though better adherence to treatment and/or through a modification of inflammation-related biomarkers.
During the present 1-year pilot study, the investigators propose to randomize 50 patients, and offer 2 MBSR groups of ≈13 patients each. Due to the bidirectional relationship between RA and depression, MBSR will be studied in patients receiving stable doses of arthritis medications during remission or low disease activity. To avoid recruitment based on thresholds of composite scores (e.g. SDAI) that are strongly impacted by depression-sensitive variables, such as Patient global evaluation of disease activity (PtVAS) and tender joint counts (TJC), the investigators will use a Swollen Joint Count (SJC) ≤2 out of 66 joints and C-Reactive Protein (CRP) ≤8 mg/L ('objective' measures) to define controlled disease. As SJC is the major determinant for RA treatment change in clinical practice, short-term RA treatment changes are unlikely in the recruited patients.
Controlled RA patients reporting Pt-VAS superior to MD-VAS by at least 20/100 units will be recruited. Blinded clinical assessors will determine the joint counts and the Examiner global evaluation of disease activity (EVAS) to determine SDAI scores at baseline and at 6 months. The French Canadian version of the CES-D and the Beck Depression Inventory to assess the importance of depressive symptoms, as well as 0-100 VAS scales (fatigue; sleep; pain; PtVAS) and Health Assessment Questionnaire (HAQ) will be obtained at both visits. Reporting will conform to the CONSORT recommendations for pilot studies.
This study reflects clinical practice, where there is heterogeneity in duration of disease, gender, age, type and dose of RA drugs used, as well as type and dose of antidepressants (when used). While the investigators suggest that RA drugs remain constant over the 6-month intervention period, treating physicians will be free to modify treatment if clinically indicated. Antidepressant use will not be an exclusion criterion.
For pragmatic reasons (e.g. uneven availability and expertise of primary care physician's (PCP), unknown effect size of the intervention), the investigators will not include a second active treatment arm with optimization of antidepressants. Instead, the investigators will inform in writing treating PCPs of their patient participation to the study and of the disconnect between Pt-VAS and MD-VAS. Changes to arthritis and depression drugs will be tracked and controlled for in analyses. For patients' safety, psychological contraindications to MBSR will be screened at baseline during a phone interview by Dr Françoise Gendron who will direct the MBSR sessions, and patients with contraindications excluded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization of consenting eligible patients in intervention and control groups using separate permutated random blocks of 4
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Mindfulness-Based Stress ReductionMindfulness-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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥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).
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Stress Reduction8 weekly 2.5 h sessions plus one day of practice | Behavioural | Intervention |
Primary outcome
Spontaneous variation in Center for Evaluation Studies - Depression (CES-D) score in controls
Time frame: 6 months
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
9 secondary outcomes
Numbers of patients recruited using current recruitment strategy
Time frame: 6 months
Impact of Mindfulness-Based Stress Reduction (MBSR) on Patient evaluation of disease activity of Rheumatoid arthritis
Time frame: 6 months
Impact of Mindfulness-Based Stress Reduction (MBSR) on Center for Epidemiologic Studies Depression Scale Revised (CES-D) depressive symptoms)
Time frame: 6 months
Impact of MBSR on anxiety
Time frame: 6 months
Impact of MBSR on pain
Time frame: 6 months
Impact of MBSR on fatigue
Time frame: 6 months
Beck Depression Inventory (BDI)
Time frame: 6 months
Numbers of patients with complete Biomarker collection
Time frame: 6 months
Numbers of patients with adverse events linked to MBSR
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Boire, MD, MSc principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction in people with Rheumatoid Arthritis and Depressive Symptoms, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous variation in Center for Evaluation Studies - Depression (CES-D) score in controls (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.