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

Weill Cornell Medicine (WCM)

Status: Enrolling

Conditions: Rheumatoid Arthritis (RA

Treatments: Behavioral: Healthy Horizons; Behavioral: Peer Coach

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07222696

25-05028875

Details and patient eligibility

About

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

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

Healthier

Experimental group

Description:

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.

Treatment:

Behavioral: Peer Coach

Healthy Horizons

Active Comparator group

Description:

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.

Treatment:

Behavioral: Healthy Horizons