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

38 Participants Needed

Trial Summary

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 data supports the idea that Mindfulness Program for Rheumatoid Arthritis is an effective treatment?

The available research shows that mindfulness programs, like Mindfulness-Based Stress Reduction (MBSR), can help people with rheumatoid arthritis by reducing depressive symptoms and improving psychological well-being. One study found that mindfulness may help lessen the impact of stress and pain on daily life. Another review suggests that mind-body therapies, including mindfulness, are seen as valuable by both patients and healthcare professionals, although the specific benefits can vary. Overall, mindfulness programs are considered helpful in managing rheumatoid arthritis, especially in improving mental health and coping with stress. ^{1 2 3 4 5}

What safety data exists for mindfulness programs in rheumatoid arthritis treatment?

The available research does not specifically address safety data for mindfulness programs in rheumatoid arthritis treatment. However, mindfulness-based interventions like Mindfulness-Based Stress Reduction (MBSR) are generally considered safe and beneficial for psychological well-being in patients with rheumatoid arthritis, as well as in other conditions such as fibromyalgia and chronic fatigue syndrome. These programs are perceived as valuable by both patients and healthcare professionals, although specific safety data is not detailed in the provided studies. ^{1 2 4 6 7}

Is the Mindfulness Program a promising treatment for Rheumatoid Arthritis?

Yes, the Mindfulness Program, which includes techniques like meditation and stress reduction, shows promise in helping people with Rheumatoid Arthritis by improving their mental well-being and possibly reducing symptoms. ^{1 2 3 4 5}

What is the purpose of this trial?

This clinical trial will test a mindfulness program in individuals with rheumatoid arthritis (RA). The main goals of this pilot study are to: * Assess patient satisfaction with a mindfulness course * Identify barriers to participation in, or completion of, a mindfulness course * Gather initial information to understand how a mindfulness course impacts RA symptoms Participants will: * Complete online questionnaires * Attend two in-person study visits, involving a brief joint exam and blood draw * Roughly half the participants will have the chance to participate in an 8-week online mindfulness course * Roughly half the participants will be invited to participate in an online focus group following completion of the mindfulness course Researchers will compare those in the mindfulness course with those receiving standard care in preparation for a larger future study to see how mindfulness impacts stress and inflammation in individuals with RA.

Research Team

Sarah L Patterson, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of Mindfulness-Based Stress Reduction in rheumatoid arthritis patients. [2015]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Meditation, Mindfulness, and Yoga in Patients with Rheumatoid Arthritis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Mindfulness interventions for rheumatoid arthritis: A systematic review and meta-analysis. [2020]

4. England pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Mindfulness and cognitive-behavioral interventions for chronic pain: differential effects on daily pain reactivity and stress reactivity. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. New Zealand 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. [2021]