250 Participants Needed

Health Coaching for Rheumatoid Arthritis

IN
SY
Overseen BySarah Young, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Weill Medical College of Cornell University
Must be taking: Disease-modifying antirheumatic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if peer coaching can reduce anxiety and depression in people with Rheumatoid Arthritis (RA). Participants will work with either a peer coach who also has RA or a coach with a different chronic condition. Each participant will engage in weekly phone sessions for 9 weeks and complete surveys to track progress. The trial seeks individuals diagnosed with RA who experience high levels of anxiety or depression and are currently on specific RA medications. As an unphased trial, this study provides a unique opportunity to explore innovative support methods for managing mental health in RA patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants must be currently taking a Disease-Modifying Anti-rheumatic drug, so you may need to continue with that medication.

What prior data suggests that this peer coaching intervention is safe for people with Rheumatoid Arthritis?

Research shows that peer coaching for people with Rheumatoid Arthritis (RA) is generally safe. Previous studies on similar programs have found that participants often feel more confident in managing their health and experience better physical function, suggesting that patients receive the program well.

Some studies mention challenges, such as participants not sticking with the program or dropping out. While some may not complete the program, these issues do not relate to safety concerns. Overall, earlier research considers the peer coaching approach safe, with no major harmful effects reported.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how peer coaching could transform life with rheumatoid arthritis (RA). Unlike traditional treatments that focus on medications like methotrexate or biologics to manage inflammation, this approach emphasizes support from someone who understands RA firsthand. The peer coach, also living with RA, offers personalized guidance and motivation through phone sessions, creating a supportive environment that could enhance mental well-being and potentially improve physical outcomes. By comparing this method to coaching from someone with a different chronic condition, researchers hope to uncover the unique benefits of shared experiences in managing RA.

What evidence suggests that peer coaching is effective for reducing anxiety and depression in people with Rheumatoid Arthritis?

Research has shown that peer coaching can be a useful tool for people with rheumatoid arthritis (RA). In this trial, participants in the "Healthier" arm will receive peer coaching from individuals who also have RA. Studies have found that peer coaches can help others manage their condition and improve mental health. Early results suggest that peer coaching can lower anxiety and depression in people with RA. A review of different peer coaching programs found that these programs help people take better care of themselves and improve their health. Thus, promising evidence suggests that peer coaching might help reduce anxiety and depression in people with RA.16789

Who Is on the Research Team?

IY

Iris Y Navarro-Millán, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adults with Rheumatoid Arthritis who may be experiencing anxiety or depression. Participants should be willing to engage with a peer coach weekly for 9 weeks and complete surveys. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I am over 18 years old.
Have high levels of depression defined as PHQ-8 scores between 10 to 20, OR high levels of anxiety based on GAD-7 scores > 10
Have access to the internet, a computer, and/or a smartphone
See 4 more

Exclusion Criteria

Severe depression defined as PHQ-8 scores of >20
I live in a nursing home.
I am currently unable to get out of bed.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive weekly peer coaching sessions over a 9-12 week period

9-12 weeks
9 telephone sessions

Post-Intervention Follow-up

Participants complete surveys at 3 weeks, 6, 12, and 24 months post-intervention to assess mental well-being

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Peer Coach
Trial Overview The study tests if peer coaching can reduce anxiety or depression in RA patients over six months, comparing it to an active-control group coached on general health by non-RA individuals.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: HealthierExperimental Treatment1 Intervention
Group II: Healthy HorizonsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials
1,103
Recruited
1,157,000+

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Citations

A Development and Feasibility Study of a Peer Support ...In summary, results from this preliminary study suggest that telephone peer support for RA patients is feasible and acceptable. The patients reported a variety ...
Health Coaching for People With Rheumatoid Arthritis to ...The goal of this clinical trial is to learn if peer coaching works to reduce levels of anxiety and/or depression in adults diagnosed with ...
Virtual training of rheumatoid arthritis peer coaches in ...Peer coaching interventions are effective in helping individuals with chronic conditions understand their disease. Most peer coach training programs occur in ...
A Scoping Review of Peer Coaching Interventions ...Peer coaching is a promising tool for patients with rheumatic musculoskeletal diseases (RMD) to improve self-care strategies and health outcomes. This scoping ...
Peer Coaching May Improve Heart Health for People with RA'” These are preliminary findings, but initial results suggest that peer coaches have a positive impact on patients with rheumatoid arthritis ...
Protocol for a pragmatic feasibility randomised controlled ...A number of studies have highlighted potential challenges of peer coaching such as coach well-being, low intervention adherence and high drop- ...
A randomized controlled trial evaluating the effects of ...The primary outcomes were patients' RA knowledge, self-efficacy and empowerment. Secondary outcomes included participation in desired health behaviors, and ...
POS1454-PARE PEER EDUCATOR PATIENTS: A NEW ...Objectives: To develop an educational program for patients with RA, led by expert patients with the same diagnosis, and previously trained for this purpose.
The Effect of a Rheumatoid Arthritis Peer Support Program ...In linear regression analyses, the mentees had a significant improvement in self-efficacy (p=0.01) and physical function (p=0.007) compared to controls (see ...
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