Recruiting

Peer CoachingHealthier: Health Coaching for People With Rheumatoid Arthritis to Improve Mental Well-Being

Sponsor:

Weill Medical College of Cornell University

Code:

NCT07222696

Conditions

Rheumatoid Arthritis (RA

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Peer Coach

Healthy Horizons

Study Details

Brief 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

Conditions

Rheumatoid Arthritis (RA

Study ID

NCT07222696

Start date

Jan 12, 2026

Status verified date

Jan, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

Having a rheumatic disease other than RA (e.g., psoriatic arthritis, gout, lupus)
Nursing home resident
History of dementia or severe cognitive decline
Are currently bedbound
Severe depression defined as PHQ-8 scores of >20.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

Peer Coach

The method that will be used in this trial will be peer coaching. Peer coaches are lay individuals who themselves have the targeted chronic condition, that for the purpose of this study is people with RA, allowing people to identify with their peers and increase confidence that they too can achieve favorable outcomes. They will use components of CBT, mindfulness, and exercise material that have been effective in improving mental and physical health in patients with RA. The Healthier intervention is distinct from these others because it focuses on a high-priority symptom experienced by people with RA: chronic pain. It mobilizes a behavior that impacts numerous dimensions beyond pain, including mobility, mood, cardiovascular health, and mortality.

Healthy Horizons

Participants in the active comparator arm will have telephone calls with a coach that does not have rheumatoid arthritis and who will deliver a nine-session intervention on general health topics that are widely available including topics on nutrition and cancer awareness. These coaches will not use CBT, mindfulness or make any references to exercise or physical activity.

Primary outcome measure

Change from Baseline in Mean Scores in PHQ-8 at 6 months post intervention [ Time Frame: Baseline and 6 months after completing the intervention (35 weeks after baseline) ]
Difference in Mean Scores in PHQ-8 Between the Experimental Arm and the Active Control Arm at 6 Months Post Intervention [ Time Frame: Six months post intervention completion (Approximately 35 weeks after baseline) ]
Change from Baseline in Mean Scores in GAD-7 at 6 months post intervention [ Time Frame: Baseline and 6 months after completing the intervention (35 weeks after baseline) ]
Difference in Mean Scores in GAD-7 Between the Experimental Arm and the Active Control Arm at 6 Months Post Intervention [ Time Frame: Six months post intervention completion (35 weeks after baseline) ]

Central Contacts and Locations

Central contacts

Iris Navarro-Millán, MD, MPH

205-529-2978 yin9003@med.cornell.edu

Sarah Young, PhD

646-962-8033 say4011@med.cornell.edu

Locations

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10065

Contacts

Iris Y Navarro-Millán, MD, MSPH

646-962-5896 research-rheum@med.cornell.edu

Principal Investigator:

Iris Navarro-Millán, MD, MPH

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Keywords

Rheumatoid Arthritis
Peer Coaching
Health Coaching
Community-based Intervention
Mental Health
Pain and mood management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-01-22.