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

NCT07222696 | Recruiting

• 1 other identifier: 25-05028875
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Change from Baseline in Mean Scores in PHQ-8 at 6 months post intervention

  Patient Health Questionnaire-8 has a range 0-24, where a higher score means more distress. The questions ask about how often participants have been affected by certain events.

  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

  Patient Health Questionnaire-8 has a range 0-24, where a higher score means more distress. The questions ask about how often participants have been affected by certain events. We will determine differences in mean scores in PHQ-8 between the experimental arm and the active control arm to establish whether or not there is a clinical significant difference between arms

  Six months post intervention completion (Approximately 35 weeks after baseline)

• Change from Baseline in Mean Scores in GAD-7 at 6 months post intervention

  General Anxiety Disorder-7 has a range 0-21, where a score of 0-4 means minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety and 15-21 severe anxiety. The questions ask about how often participants have been affected by certain events.

  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

  General Anxiety Disorder-7 has a range 0-21, where a score of 0-4 means minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety and 15-21 severe anxiety. The questions ask about how often participants have been affected by certain events. We will determine differences in mean scores between the experimental arm and the active control arm to establish whether or not there is a clinical significant difference between arms,

  Six months post intervention completion (35 weeks after baseline)

Secondary Outcomes (96)

• Change from Baseline in Mean Scores in PROMIS Pain Interference Midway Through the Intervention

  Baseline, Midway through the intervention (4 weeks after baseline)

• Change from Baseline in Mean Scores in PROMIS Pain Interference at 3 Weeks Post-Intervention

  Baseline, 3 Weeks Post-Intervention (12 weeks after baseline)

• Change from Baseline in Mean Scores in PROMIS Pain Interference at 6 Months Post-Intervention Completion

  Baseline, 6 months post intervention completion (35 weeks after baseline)

• Change from Baseline in Mean Scores in PROMIS Pain Interference at 12 Months Post-Intervention Completion

  Baseline, 12 months post-intervention completion (61 weeks after baseline)

• Change from Baseline in Mean Scores in PROMIS Pain Interference at 24 Months Post-Intervention Completion

  Baseline, 24 months post-intervention completion (113 weeks after baseline)

Study Arms (2)

Healthier

EXPERIMENTAL

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.

Behavioral: Peer Coach

Healthy Horizons

ACTIVE COMPARATOR

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.

Behavioral: Healthy Horizons

Interventions

Peer Coach BEHAVIORAL

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.

Healthier

Healthy Horizons BEHAVIORAL

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.

Healthy Horizons

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

RECRUITING

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MeSH Terms

Conditions

Arthritis, Rheumatoid; Psychological Well-Being; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Personal Satisfaction; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Iris Y Navarro-Millán, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iris Navarro-Millán, MD, MPH

CONTACT

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

Sarah Young, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2025
• First Posted: October 30, 2025
• Study Start: January 12, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 9 months following the last data collection and ending 72 months following publication.
• Access Criteria: Investigators may request data for meta-analysis. Proposals should be directed to yin9003@med.cornell.edu to gain access, data requestors will need to sign a data access agreement upon data availability.

Locations

US (1)