NCT07222696 · Weill Medical College of Cornell University
Healthier: Health Coaching for People With Rheumatoid Arthritis to Improve Mental Well-Being
What this study is 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).
View original scientific description
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.
Interventions
BEHAVIORAL
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.
BEHAVIORAL
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 measures
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)
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.
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)
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
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)
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.
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)
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,
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- New York, New York
Collaborators
Bristol-Myers Squibb
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 22, 2026 · Source of record for eligibility and locations