Mindfulness Program for Rheumatoid Arthritis

(DREAMER Trial)

Overseen By Sarah M Fisher, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: RA remission, Regular mindfulness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a mindfulness program can assist people with rheumatoid arthritis (RA), a condition that causes joint pain and swelling. Participants will either join an 8-week online mindfulness course or continue their usual care. The researchers aim to determine if mindfulness can reduce stress and inflammation, and to assess patient satisfaction and any challenges with the program. This trial suits individuals with a confirmed RA diagnosis who do not regularly practice mindfulness. As an unphased trial, it offers participants the chance to explore innovative approaches to managing RA symptoms through mindfulness.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop your current medications. It seems likely that you can continue them, as the focus is on mindfulness, not medication changes.

What prior data suggests that this mindfulness program is safe for individuals with rheumatoid arthritis?

Research shows that mindfulness programs, like the one under testing, are generally safe. Studies have found that these programs can reduce stress and improve mood in people with rheumatoid arthritis (RA) without causing harmful side effects.

Mindfulness-based stress reduction (MBSR) is a well-known program used in many studies. Participants often report improved mental well-being after completing it. There are no significant reports of harmful effects from this type of treatment. This suggests that the mindfulness program being tested should be well-tolerated by people with RA. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mindfulness Program for rheumatoid arthritis because it offers a non-drug approach to managing this chronic condition. Unlike standard treatments, which often involve medications like NSAIDs, DMARDs, or biologics that can have significant side effects, this program focuses on mental well-being through an 8-week mindfulness course specifically adapted for people with rheumatic diseases. The program aims to reduce stress and improve quality of life, potentially reducing pain and inflammation naturally. This unique approach could complement existing treatments, offering patients an additional tool to manage their symptoms effectively.

What evidence suggests that this mindfulness program is effective for rheumatoid arthritis?

Research shows that mindfulness activities can greatly help people with rheumatoid arthritis (RA). In this trial, participants in the mindfulness group will complete an 8-week mindfulness course tailored for individuals with rheumatic diseases. Studies have found that mindfulness programs can reduce pain and depression in RA patients more effectively than traditional treatments. These programs also alleviate mental stress, a common issue for those with RA. Mindfulness-Based Cognitive Therapy (MBCT) has changed how patients perceive their illness, leading to a better overall experience. Overall, mindfulness practices offer a promising way to improve well-being and manage symptoms for those with RA. ^{1 3 5 6 7}

Who Is on the Research Team?

Sarah L Patterson, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals with an active rheumatoid arthritis diagnosis who can access the internet via a computer or mobile device. It's not suitable for those in RA remission, already practicing mindfulness regularly, unable to commit to an 8-week course, or have completed a similar MBSR course before.

Inclusion Criteria

Access to a web-enabled computer, smartphone, or tablet

My doctor has diagnosed me with rheumatoid arthritis.

Exclusion Criteria

My rheumatoid arthritis is currently in remission.

Prior participation in a mindfulness-based stress reduction (MBSR) course

Inability to participate in an intensive 8-week online mindfulness course

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Enrollment and Baseline Assessment

Participants meet with study staff, provide consent, and complete baseline assessments including a joint exam and blood draw

1 week

1 visit (in-person)

Treatment

Participants are randomly assigned to either an 8-week online mindfulness course or treatment-as-usual

8 weeks

Online sessions for mindfulness group

Follow-up

Participants complete a final in-person study visit with procedures similar to the baseline assessment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness Program

Trial Overview The study tests a mindfulness program against standard care in people with rheumatoid arthritis. Participants will fill out questionnaires, undergo exams and blood draws, and may join an online mindfulness course or focus group to evaluate satisfaction and barriers.

How Is the Trial Designed?

Group I: Mindfulness Program Experimental Treatment 1 Intervention

Individuals in the mindfulness group will complete an 8-week mindfulness course that has been adapted for individuals with rheumatic diseases (MBSR-RD).

Group II: Treatment as Usual (TAU) Active Control 1 Intervention

Individuals in the TAU group will continue engaging in routine care and be asked to refrain from participating in mindfulness programs during the trial.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

In a study of 201 rheumatoid arthritis patients, higher levels of mindfulness at baseline were strongly linked to lower psychological distress over a 12-month period, suggesting mindfulness can help improve mental well-being in these patients.

The research also indicated that mindfulness may specifically reduce psychological distress related to disability, highlighting its potential as a protective factor against the mental health impacts of chronic illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological distress across twelve months in patients with rheumatoid arthritis: the role of disease activity, disability, and mindfulness. Nyklíček, I., Hoogwegt, F., Westgeest, T.[2018]

A 10-week mindfulness-based stress reduction (MBSR) program significantly improved psychological distress in women with conditions like multiple chemical sensitivity, chronic fatigue syndrome, and fibromyalgia, as shown by a large sample of 50 participants compared to 26 control subjects.

Improvements were statistically significant both immediately after the program and at a three-month follow-up, indicating that MBSR can be an effective complementary intervention for managing symptoms in these chronic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled study of the effect of a mindfulness-based stress reduction technique in women with multiple chemical sensitivity, chronic fatigue syndrome, and fibromyalgia. Sampalli, T., Berlasso, E., Fox, R., et al.[2021]

Mind-body therapies (MBTs) like meditation, yoga, and mindfulness have been found to improve patient-reported outcomes such as vitality, functioning, and mental health in individuals with rheumatoid arthritis (RA), based on a systematic review of 23 studies involving 1527 records.

Patients with RA who also experience recurrent depression may gain even more benefits from these non-pharmacological therapies, suggesting that MBTs can play a valuable role in managing RA, particularly for those with mental health challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Meditation, Mindfulness, and Yoga in Patients with Rheumatoid Arthritis. Slagter, L., Demyttenaere, K., Verschueren, P., et al.[2022]

Mindful awareness and acceptance treatment (M) was more effective than cognitive-behavioral therapy for pain (CBT-P) and arthritis education (E) in reducing daily pain-related catastrophizing, morning disability, and fatigue among 143 adults with rheumatoid arthritis (RA).

M also led to greater reductions in daily stress-related anxious affect compared to the other treatments, indicating its broad effectiveness in improving daily pain and stress responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness and cognitive-behavioral interventions for chronic pain: differential effects on daily pain reactivity and stress reactivity. Davis, MC., Zautra, AJ., Wolf, LD., et al.[2022]

In a pilot study involving 63 participants with rheumatoid arthritis, an 8-week Mindfulness-Based Stress Reduction (MBSR) program showed significant improvements in psychological distress and well-being after 6 months, but not at the 2-month mark.

While MBSR did not affect depressive symptoms or rheumatoid arthritis disease activity, it may serve as a beneficial complement to medical treatment by enhancing psychological health in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Mindfulness-Based Stress Reduction in rheumatoid arthritis patients. Pradhan, EK., Baumgarten, M., Langenberg, P., et al.[2015]

An abbreviated Mindfulness-Based Stress Reduction (MBSR) program consisting of 6 weekly 75-minute sessions can effectively be implemented during staff lunch breaks, making it a practical training option for healthcare providers and clinic staff.

This adapted MBSR program is not only feasible but also well-accepted, suggesting it could enhance the well-being of healthcare workers in a workplace setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction for Health Care Staff: Expanding Holistic Nursing Paradigms to the Whole System. Hazlett-Stevens, H.[2021]

Mindfulness interventions significantly reduced pain intensity and depression in patients with rheumatoid arthritis compared to conventional therapy, based on a review of 6 randomized controlled trials involving 337 patients.

The study also found improvements in disease activity scores (DSA28) among those receiving mindfulness interventions, indicating potential benefits in managing rheumatoid arthritis symptoms, although further high-quality research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness interventions for rheumatoid arthritis: A systematic review and meta-analysis. Zhou, B., Wang, G., Hong, Y., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6233984/

Systematic Review and Meta-analysis: Mindfulness-Based ... Preliminary findings suggest that MBIs may be a useful strategy to improve psychological distress in those with RA.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30712718/

The effectiveness of Mindfulness-Based Cognitive Therapy ... MBCT is effective on IP and psychological syndrome and can be used as an MBI method to reduce the illness perceptions in people with RA.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1744388119308357

Mindfulness interventions for rheumatoid arthritis Mindfulness interventions can significantly improve pain intensity, depression, and symptoms in patients with rheumatoid arthritis compared with conventional ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06276387

Defining Stress REsilience And Mindfulness Effects in ... This clinical trial will test a mindfulness program in individuals with rheumatoid arthritis (RA). The main goals of this pilot study are to:.

5. psychsyt.ca psychsyt.ca/ESW/Files/MBSR_for_arthritis_-_2007.pdf

Effect of Mindfulness-Based Stress Reduction in ... Significant improvements in psychological distress and well-being were observed following MBSR plus a 4-month program of continued reinforcement. Mindfulness ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03411057

Mindfulness Based Stress Reduction in Rheumatic Diseases This study will assess the mental health and clinical benefits of Mindfulness Based Stress Reduction (MBSR) in patients with rheumatic disease who have ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6613793/

Mindfulness Training and Physical Health: Mechanisms and ... The 8-week Mindfulness-Based Stress Reduction (MBSR) program is the most popular mindfulness intervention used in the scientific literature, and consists of ...