Pilot Randomized Trial of Health Coaching for People With Rheumatoid Arthritis to Improve Mental Well-Being

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 Rheumatoid Arthritis (RA). The main questions it aims to answer are: Do people with RA who complete the intervention with a peer coach have lower levels of anxiety and/or depression at 6 months from baseline? Do people with RA who complete the intervention with a peer coach have lower levels of anxiety and/or depression at 6 months compared to those in the control arm? Researchers will compare the peer coaching intervention to an active-control arm (where people without RA coach participants on general health and nutrition topics) to see if peer coaching works to reduce anxiety and/or depression. Participants will meet with a coach every week for 9 weeks and complete several surveys before, during and after the intervention

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or Female older than 18 years of age.

• Have a diagnosis of Rheumatoid Arthritis by a rheumatologist and currently taking a Disease-Modifying Anti-rheumatic drug ( Conventional Disease-Modifying Anti-rheumatic drug and/or Biological Disease-Modifying Anti-rheumatic drug)

• 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

• Speaks English or Spanish

• Have access to the internet, a computer, and/or a smartphone

• Resides or lives in any state of the US, including Puerto Rico

• Willing to work with a peer coach or a coach

Locations
United States
New York
Weill Cornell Medical College
RECRUITING
New York
Contact Information
Primary
Iris Navarro-Millán, MD, MPH
yin9003@med.cornell.edu
205-529-2978
Backup
Sarah Young, PhD
say4011@med.cornell.edu
646-962-8033
Time Frame
Start Date: 2025-12
Estimated Completion Date: 2030-12
Participants
Target number of participants: 250
Treatments
Experimental: Healthier
Participants will have 9 telephone-delivered sessions, over a 9-12-week period, delivered by a peer coach (another person with RA). Data will be collected at baseline, midway through the intervention (after Session 4 of the intervention), 3 weeks after completion of the intervention, 6, 12, and 24 months after completion of the intervention using validated instruments.
Active_comparator: Healthy Horizons
Participants from will have 9 telephone-delivered sessions over a 9-12-week period delivered by a coach (a person without RA but who has a different chronic condition like osteoarthritis or diabetes). Data will be collected at baseline, midway through the intervention (after Session 4 of the intervention), 3 weeks after completion of the intervention, 6, 12, and 24 months after completion of the intervention using validated instruments.
Sponsors
Collaborators: Bristol-Myers Squibb
Leads: Weill Medical College of Cornell University

This content was sourced from clinicaltrials.gov