AzTrials
AzTrials

Rheumatoid Arthritis (RANCT07222696

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

A study testing Peer Coach and Healthy Horizons in people with Rheumatoid Arthritis (RA, run by Weill Medical College of Cornell University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis (RA
What is being tested?
Peer Coach and Healthy Horizons
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteUnited States
Study dates
12 Jan 2026to Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Iris Navarro-Millán, MD, MPH contact

205-529-2978

yin9003@med.cornell.edu

Sarah Young, PhD contact

646-962-8033

say4011@med.cornell.edu

United States1 site, 1 recruiting

  • Weill Cornell Medical College

    New York, New York, 10065

    Iris Y Navarro-Millán, MD, MSPH, 646-962-5896, research-rheum@med.cornell.edu

    Iris Navarro-Millán, MD, MPH

    Recruiting

Other trials in United States

About this study

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

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

Being tested
Peer Coach, Healthy Horizons
Keywords
Rheumatoid Arthritis, Peer Coaching, Health Coaching, Community-based Intervention, Mental Health, Pain and mood management
Medical subject headings
Arthritis, Rheumatoid, Psychological Well-Being, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peer CoachBehavioural

    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 HorizonsBehavioural

    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.

Study groups in NCT07222696
Study groupRoleWhat they receive
HealthierExperimentalParticipants 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.
Receives: Behavioral: Peer Coach
Healthy HorizonsActive comparatorParticipants 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.
Receives: Behavioral: Healthy Horizons

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 6 months after completing the intervention (35 weeks after baseline)

  2. 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

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

  3. 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.

    Measured: Baseline and 6 months after completing the intervention (35 weeks after baseline)

  4. 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,

    Measured: Six months post intervention completion (35 weeks after baseline)

Secondary outcomes (96)

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

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference has a range of T-scores typically from 40 to 80, where a higher score means greater interference of pain with daily activities. The questions ask about how often pain has affected aspects of life such as social, cognitive, emotional, physical, and recreational functioning.

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

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

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference has a range of T-scores typically from 40 to 80, where a higher score means greater interference of pain with daily activities. The questions ask about how often pain has affected aspects of life such as social, cognitive, emotional, physical, and recreational functioning.

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

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

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference has a range of T-scores typically from 40 to 80, where a higher score means greater interference of pain with daily activities. The questions ask about how often pain has affected aspects of life such as social, cognitive, emotional, physical, and recreational functioning.

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

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

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference has a range of T-scores typically from 40 to 80, where a higher score means greater interference of pain with daily activities. The questions ask about how often pain has affected aspects of life such as social, cognitive, emotional, physical, and recreational functioning.

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

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

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference has a range of T-scores typically from 40 to 80, where a higher score means greater interference of pain with daily activities. The questions ask about how often pain has affected aspects of life such as social, cognitive, emotional, physical, and recreational functioning.

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

  6. Difference in Mean Scores in PROMIS Pain Interference Between the Experimental Arm and the Active Control Arm Midway Through the Intervention

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference has a range of T-scores typically from 40 to 80, where a higher score means greater interference of pain with daily activities. The questions ask about how often pain has affected aspects of life such as social, cognitive, emotional, physical, and recreational functioning. 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

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

  7. Difference in Mean Scores in PROMIS Pain Interference Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference has a range of T-scores typically from 40 to 80, where a higher score means greater interference of pain with daily activities. The questions ask about how often pain has affected aspects of life such as social, cognitive, emotional, physical, and recreational functioning. 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

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

  8. Difference in Mean Scores in PROMIS Pain Interference Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference has a range of T-scores typically from 40 to 80, where a higher score means greater interference of pain with daily activities. The questions ask about how often pain has affected aspects of life such as social, cognitive, emotional, physical, and recreational functioning. 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

    Measured: Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline)

  9. Difference in Mean Scores in PROMIS Pain Interference Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference has a range of T-scores typically from 40 to 80, where a higher score means greater interference of pain with daily activities. The questions ask about how often pain has affected aspects of life such as social, cognitive, emotional, physical, and recreational functioning. 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

    Measured: Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)

  10. Difference in Mean Scores in PROMIS Pain Interference Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference has a range of T-scores typically from 40 to 80, where a higher score means greater interference of pain with daily activities. The questions ask about how often pain has affected aspects of life such as social, cognitive, emotional, physical, and recreational functioning. 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

    Measured: Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)

  11. Change from Baseline in Mean Scores in PROMIS Sleep Disturbance Midway Through the Intervention

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance has a range of T-scores typically from 40 to 80, where a higher score means greater interference of poor sleep with daily functioning and well-being. The questions ask about how often sleep problems have affected aspects of life such as alertness, mood, concentration, and energy..

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

  12. Change from Baseline in Mean Scores in PROMIS Sleep Disturbance at 3 Weeks Post-Intervention

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance has a range of T-scores typically from 40 to 80, where a higher score means greater interference of poor sleep with daily functioning and well-being. The questions ask about how often sleep problems have affected aspects of life such as alertness, mood, concentration, and energy..

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

  13. Change from Baseline in Mean Scores in PROMIS Sleep Disturbance at 6 Months Post-Intervention Completion

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance has a range of T-scores typically from 40 to 80, where a higher score means greater interference of poor sleep with daily functioning and well-being. The questions ask about how often sleep problems have affected aspects of life such as alertness, mood, concentration, and energy..

    Measured: Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline)

  14. Change from Baseline in Mean Scores in PROMIS Sleep Disturbance at 12 Months Post-Intervention Completion

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance has a range of T-scores typically from 40 to 80, where a higher score means greater interference of poor sleep with daily functioning and well-being. The questions ask about how often sleep problems have affected aspects of life such as alertness, mood, concentration, and energy..

    Measured: Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)

  15. Change from Baseline in Mean Scores in PROMIS Sleep Disturbance at 24 Months Post-Intervention Completion

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance has a range of T-scores typically from 40 to 80, where a higher score means greater interference of poor sleep with daily functioning and well-being. The questions ask about how often sleep problems have affected aspects of life such as alertness, mood, concentration, and energy..

    Measured: Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)

  16. Difference in Mean Scores in PROMIS Sleep Disturbance Between the Experimental Arm and the Active Control Arm Midway Through the Intervention

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance has a range of T-scores typically from 40 to 80, where a higher score means greater interference of poor sleep with daily functioning and well-being. The questions ask about how often sleep problems have affected aspects of life such as alertness, mood, concentration, and energy. 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

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

  17. Difference in Mean Scores in PROMIS Sleep Disturbance Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance has a range of T-scores typically from 40 to 80, where a higher score means greater interference of poor sleep with daily functioning and well-being. The questions ask about how often sleep problems have affected aspects of life such as alertness, mood, concentration, and energy. 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

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

  18. Difference in Mean Scores in PROMIS Sleep Disturbance Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance has a range of T-scores typically from 40 to 80, where a higher score means greater interference of poor sleep with daily functioning and well-being. The questions ask about how often sleep problems have affected aspects of life such as alertness, mood, concentration, and energy. 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

    Measured: Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline)

  19. Difference in Mean Scores in PROMIS Sleep Disturbance Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance has a range of T-scores typically from 40 to 80, where a higher score means greater interference of poor sleep with daily functioning and well-being. The questions ask about how often sleep problems have affected aspects of life such as alertness, mood, concentration, and energy. 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

    Measured: Baseline, 12 Months Post-Intervention Completion(61 weeks after baseline)

  20. Difference in Mean Scores in PROMIS Sleep Disturbance Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance has a range of T-scores typically from 40 to 80, where a higher score means greater interference of poor sleep with daily functioning and well-being. The questions ask about how often sleep problems have affected aspects of life such as alertness, mood, concentration, and energy. 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

    Measured: Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)

  21. Change from Baseline in Mean Scores in Short Form-12 Midway Through the Intervention

    Short Form-12 Health Survey (SF-12) has a range of 0 to 100, where higher scores indicate better health status. The questions ask about physical and mental health over the past four weeks, covering areas such as physical functioning, role limitations, pain, general health, vitality, social functioning, and emotional well-being.

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

  22. Change from Baseline in Mean Scores in Short Form-12 at 3 Weeks Post-Intervention

    Short Form-12 Health Survey (SF-12) has a range of 0 to 100, where higher scores indicate better health status. The questions ask about physical and mental health over the past four weeks, covering areas such as physical functioning, role limitations, pain, general health, vitality, social functioning, and emotional well-being.

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

  23. Change from Baseline in Mean Scores in Short Form-12 at 6 Months Post-Intervention Completion

    Short Form-12 Health Survey (SF-12) has a range of 0 to 100, where higher scores indicate better health status. The questions ask about physical and mental health over the past four weeks, covering areas such as physical functioning, role limitations, pain, general health, vitality, social functioning, and emotional well-being.

    Measured: Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline)

  24. Change from Baseline in Mean Scores in Short Form-12 at 12 Months Post-Intervention Completion

    Short Form-12 Health Survey (SF-12) has a range of 0 to 100, where higher scores indicate better health status. The questions ask about physical and mental health over the past four weeks, covering areas such as physical functioning, role limitations, pain, general health, vitality, social functioning, and emotional well-being.

    Measured: Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)

  25. Change from Baseline in Mean Scores in Short Form-12 at 24 Months Post-Intervention Completion

    Short Form-12 Health Survey (SF-12) has a range of 0 to 100, where higher scores indicate better health status. The questions ask about physical and mental health over the past four weeks, covering areas such as physical functioning, role limitations, pain, general health, vitality, social functioning, and emotional well-being.

    Measured: Baseline, 24 Months Post-Intervention Completion(113 weeks after baseline)

  26. Difference in Mean Scores in Short-Form 12 Between the Experimental Arm and the Active Control Arm Midway Through the Intervention

    Short Form-12 Health Survey (SF-12) has a range of 0 to 100, where higher scores indicate better health status. The questions ask about physical and mental health over the past four weeks, covering areas such as physical functioning, role limitations, pain, general health, vitality, social functioning, and emotional well-being. 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.

    Measured: Baseline, Midway Through the intervention(4 weeks after baseline)

  27. Difference in Mean Scores in Short-Form 12 Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention

    Short Form-12 Health Survey (SF-12) has a range of 0 to 100, where higher scores indicate better health status. The questions ask about physical and mental health over the past four weeks, covering areas such as physical functioning, role limitations, pain, general health, vitality, social functioning, and emotional well-being. 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.

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

  28. Difference in Mean Scores in Short-Form 12 Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion

    Short Form-12 Health Survey (SF-12) has a range of 0 to 100, where higher scores indicate better health status. The questions ask about physical and mental health over the past four weeks, covering areas such as physical functioning, role limitations, pain, general health, vitality, social functioning, and emotional well-being. 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.

    Measured: Baseline, 6 Months Post-Intervention Completion(35 weeks after baseline)

  29. Difference in Mean Scores in Short-Form 12 Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion

    Short Form-12 Health Survey (SF-12) has a range of 0 to 100, where higher scores indicate better health status. The questions ask about physical and mental health over the past four weeks, covering areas such as physical functioning, role limitations, pain, general health, vitality, social functioning, and emotional well-being. 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.

    Measured: Baseline, 12 Months Post-Intervention Completion(61 weeks after baseline)

  30. Difference in Mean Scores in Short-Form 12 Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion

    Short Form-12 Health Survey (SF-12) has a range of 0 to 100, where higher scores indicate better health status. The questions ask about physical and mental health over the past four weeks, covering areas such as physical functioning, role limitations, pain, general health, vitality, social functioning, and emotional well-being. 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.

    Measured: Baseline, 24 Months Post-Intervention Completion(113 weeks after baseline)

  31. Change from Baseline in Mean Scores in PROMIS Physical Function Midway Through the Intervention

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function has a range of T-scores typically from 20 to 80, where a higher score means better physical functioning. The questions ask about the ability to perform everyday activities such as walking, climbing stairs, carrying groceries, or engaging in recreational activities.

    Measured: Baseline, Midway Through the Intervention (4 weeks after baseline)

  32. Change from Baseline in Mean Scores in PROMIS Physical Function at 3 Weeks Post-Intervention

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function has a range of T-scores typically from 20 to 80, where a higher score means better physical functioning. The questions ask about the ability to perform everyday activities such as walking, climbing stairs, carrying groceries, or engaging in recreational activities.

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

  33. Change from Baseline in Mean Scores in PROMIS Physical Function at 6 Months Post-Intervention Completion

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function has a range of T-scores typically from 20 to 80, where a higher score means better physical functioning. The questions ask about the ability to perform everyday activities such as walking, climbing stairs, carrying groceries, or engaging in recreational activities.

    Measured: Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline)

  34. Change from Baseline in Mean Scores in PROMIS Physical Function at 12 Months Post-Intervention Completion

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function has a range of T-scores typically from 20 to 80, where a higher score means better physical functioning. The questions ask about the ability to perform everyday activities such as walking, climbing stairs, carrying groceries, or engaging in recreational activities.

    Measured: Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)

  35. Change from Baseline in Mean Scores in PROMIS Physical Function at 24 Months Post-Intervention Completion

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function has a range of T-scores typically from 20 to 80, where a higher score means better physical functioning. The questions ask about the ability to perform everyday activities such as walking, climbing stairs, carrying groceries, or engaging in recreational activities.

    Measured: Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)

  36. Difference in Mean Scores in PROMIS Physical Function Between the Experimental Arm and the Active Control Arm Midway Through the Intervention

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function has a range of T-scores typically from 20 to 80, where a higher score means better physical functioning. The questions ask about the ability to perform everyday activities such as walking, climbing stairs, carrying groceries, or engaging in recreational activities. 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

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

  37. Difference in Mean Scores in PROMIS Physical Function Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function has a range of T-scores typically from 20 to 80, where a higher score means better physical functioning. The questions ask about the ability to perform everyday activities such as walking, climbing stairs, carrying groceries, or engaging in recreational activities. 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

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

  38. Difference in Mean Scores in PROMIS Physical Function Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function has a range of T-scores typically from 20 to 80, where a higher score means better physical functioning. The questions ask about the ability to perform everyday activities such as walking, climbing stairs, carrying groceries, or engaging in recreational activities. 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

    Measured: Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline)

  39. Difference in Mean Scores in PROMIS Physical Function Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function has a range of T-scores typically from 20 to 80, where a higher score means better physical functioning. The questions ask about the ability to perform everyday activities such as walking, climbing stairs, carrying groceries, or engaging in recreational activities. 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

    Measured: Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)

  40. Difference in Mean Scores in PROMIS Physical Function Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completionn

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function has a range of T-scores typically from 20 to 80, where a higher score means better physical functioning. The questions ask about the ability to perform everyday activities such as walking, climbing stairs, carrying groceries, or engaging in recreational activities. 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

    Measured: Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)

  41. Change from Baseline in Mean Scores in Lubben Social Isolation Midway Through the Intervention

    Lubben Social Isolation or Lubben Social Network Scale (LSNS-6) has a range of 0 to 30, where higher scores indicate stronger social connectedness and lower risk of isolation. The questions ask about the number of relatives and friends with whom participants have regular contact, feel close to, or can call on for help.

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

  42. Change from Baseline in Mean Scores in Lubben Social Isolation at 3 Weeks Post-Intervention

    Lubben Social Isolation or Lubben Social Network Scale (LSNS-6) has a range of 0 to 30, where higher scores indicate stronger social connectedness and lower risk of isolation. The questions ask about the number of relatives and friends with whom participants have regular contact, feel close to, or can call on for help.

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

  43. Change from Baseline in Mean Scores in Lubben Social Isolation at 6 Months Post-Intervention Completion

    Lubben Social Isolation or Lubben Social Network Scale (LSNS-6) has a range of 0 to 30, where higher scores indicate stronger social connectedness and lower risk of isolation. The questions ask about the number of relatives and friends with whom participants have regular contact, feel close to, or can call on for help.

    Measured: Baseline, 6 Months Post-Intervention Completion( 35 weeks after baseline)

  44. Change from Baseline in Mean Scores in Lubben Social Isolation at 12 Months Post-Intervention Completion

    Lubben Social Isolation or Lubben Social Network Scale (LSNS-6) has a range of 0 to 30, where higher scores indicate stronger social connectedness and lower risk of isolation. The questions ask about the number of relatives and friends with whom participants have regular contact, feel close to, or can call on for help.

    Measured: Baseline, 12 Months Post-Intervention Completion( 61 weeks after baseline)

  45. Change from Baseline in Mean Scores in Lubben Social Isolation at 24 Months Post-Intervention Completion

    Lubben Social Isolation or Lubben Social Network Scale (LSNS-6) has a range of 0 to 30, where higher scores indicate stronger social connectedness and lower risk of isolation. The questions ask about the number of relatives and friends with whom participants have regular contact, feel close to, or can call on for help.

    Measured: Baseline, 24 Months Post-Intervention Completion( 113 weeks after baseline)

  46. Difference in Mean Scores in Lubben Social Isolation Between the Experimental Arm and the Active Control Arm Midway Through the Intervention

    Lubben Social Isolation or Lubben Social Network Scale (LSNS-6) has a range of 0 to 30, where higher scores indicate stronger social connectedness and lower risk of isolation. The questions ask about the number of relatives and friends with whom participants have regular contact, feel close to, or can call on for help. 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

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

  47. Difference in Mean Scores in Lubben Social Isolation Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention

    Lubben Social Isolation or Lubben Social Network Scale (LSNS-6) has a range of 0 to 30, where higher scores indicate stronger social connectedness and lower risk of isolation. The questions ask about the number of relatives and friends with whom participants have regular contact, feel close to, or can call on for help. 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

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

  48. Difference in Mean Scores in Lubben Social Isolation Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion

    Lubben Social Isolation or Lubben Social Network Scale (LSNS-6) has a range of 0 to 30, where higher scores indicate stronger social connectedness and lower risk of isolation. The questions ask about the number of relatives and friends with whom participants have regular contact, feel close to, or can call on for help. 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

    Measured: Baseline, 6 Months Post-Intervention Completion(35 weeks after baseline)

  49. Difference in Mean Scores in Lubben Social Isolation Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion

    Lubben Social Isolation or Lubben Social Network Scale (LSNS-6) has a range of 0 to 30, where higher scores indicate stronger social connectedness and lower risk of isolation. The questions ask about the number of relatives and friends with whom participants have regular contact, feel close to, or can call on for help. 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

    Measured: Baseline, 12 Months Post-Intervention Completion(61 weeks after baseline)

  50. Difference in Mean Scores in Lubben Social Isolation Between the Experimental Arm and the Active Control Arm 24 Months Post-Intervention Completion

    Lubben Social Isolation or Lubben Social Network Scale (LSNS-6) has a range of 0 to 30, where higher scores indicate stronger social connectedness and lower risk of isolation. The questions ask about the number of relatives and friends with whom participants have regular contact, feel close to, or can call on for help. 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

    Measured: Baseline, 24 Months Post-Intervention Completion(113 weeks after baseline)

  51. Change from Baseline in Mean Scores in Cohen Stress Scale Midway Through the Intervention

    Cohen's Perceived Stress Scale (PSS) has a range of 0 to 40, where higher scores indicate greater perceived stress. The questions ask about how often participants have felt stressed, overwhelmed, or unable to control important aspects of their life over the past month. Scores of 0-13 are considered low stress, 14-26 moderate stress, and 27-40 high stress

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

  52. Change from Baseline in Mean Scores in Cohen Stress Scale at 3 Weeks Post-Intervention

    Cohen's Perceived Stress Scale (PSS) has a range of 0 to 40, where higher scores indicate greater perceived stress. The questions ask about how often participants have felt stressed, overwhelmed, or unable to control important aspects of their life over the past month. Scores of 0-13 are considered low stress, 14-26 moderate stress, and 27-40 high stress

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

  53. Change from Baseline in Mean Scores in Cohen Stress Scale at 6 Months Post-Intervention Completion

    Cohen's Perceived Stress Scale (PSS) has a range of 0 to 40, where higher scores indicate greater perceived stress. The questions ask about how often participants have felt stressed, overwhelmed, or unable to control important aspects of their life over the past month. Scores of 0-13 are considered low stress, 14-26 moderate stress, and 27-40 high stress

    Measured: Baseline, 6 Months Post-Intervention Completion(35 weeks after baseline)

  54. Change from Baseline in Mean Scores in Cohen Stress Scale at 12 Months Post-Intervention Completion

    Cohen's Perceived Stress Scale (PSS) has a range of 0 to 40, where higher scores indicate greater perceived stress. The questions ask about how often participants have felt stressed, overwhelmed, or unable to control important aspects of their life over the past month. Scores of 0-13 are considered low stress, 14-26 moderate stress, and 27-40 high stress

    Measured: Baseline, 12 Months Post-Intervention Completion(61 weeks after baseline)

  55. Change from Baseline in Mean Scores in Cohen Stress Scale at 24 Months Post-Intervention Completion

    Cohen's Perceived Stress Scale (PSS) has a range of 0 to 40, where higher scores indicate greater perceived stress. The questions ask about how often participants have felt stressed, overwhelmed, or unable to control important aspects of their life over the past month. Scores of 0-13 are considered low stress, 14-26 moderate stress, and 27-40 high stress

    Measured: Baseline, 24 Months Post-Intervention Completion(113 weeks after baseline)

  56. Difference in Mean Scores in Cohen Stress Scale Between the Experimental Arm and the Active Control Arm Midway Through the Intervention

    Cohen's Perceived Stress Scale (PSS) has a range of 0 to 40, where higher scores indicate greater perceived stress. The questions ask about how often participants have felt stressed, overwhelmed, or unable to control important aspects of their life over the past month. Scores of 0-13 are considered low stress, 14-26 moderate stress, and 27-40 high stress. 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

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

  57. Difference in Mean Scores in Cohen Stress Scale Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention

    Cohen's Perceived Stress Scale (PSS) has a range of 0 to 40, where higher scores indicate greater perceived stress. The questions ask about how often participants have felt stressed, overwhelmed, or unable to control important aspects of their life over the past month. Scores of 0-13 are considered low stress, 14-26 moderate stress, and 27-40 high stress. 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

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

  58. Difference in Mean Scores in Cohen Stress Scale Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion

    Cohen's Perceived Stress Scale (PSS) has a range of 0 to 40, where higher scores indicate greater perceived stress. The questions ask about how often participants have felt stressed, overwhelmed, or unable to control important aspects of their life over the past month. Scores of 0-13 are considered low stress, 14-26 moderate stress, and 27-40 high stress. 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

    Measured: Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline)

  59. Difference in Mean Scores in Cohen Stress Scale Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion

    Cohen's Perceived Stress Scale (PSS) has a range of 0 to 40, where higher scores indicate greater perceived stress. The questions ask about how often participants have felt stressed, overwhelmed, or unable to control important aspects of their life over the past month. Scores of 0-13 are considered low stress, 14-26 moderate stress, and 27-40 high stress. 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

    Measured: Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)

  60. Difference in Mean Scores in Cohen Stress Scale Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion

    Cohen's Perceived Stress Scale (PSS) has a range of 0 to 40, where higher scores indicate greater perceived stress. The questions ask about how often participants have felt stressed, overwhelmed, or unable to control important aspects of their life over the past month. Scores of 0-13 are considered low stress, 14-26 moderate stress, and 27-40 high stress. 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

    Measured: Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)

  61. Change from Baseline in Mean Scores in UCLA Loneliness Scale Midway Through the Intervention

    UCLA Loneliness Scale has a range of 20 to 80, where higher scores indicate greater loneliness. The questions ask about how often participants feel lacking in companionship, left out, or isolated from others.

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

  62. Change from Baseline in Mean Scores in UCLA Loneliness Scale at 3 Weeks Post-Intervention

    UCLA Loneliness Scale has a range of 20 to 80, where higher scores indicate greater loneliness. The questions ask about how often participants feel lacking in companionship, left out, or isolated from others.

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

  63. Change from Baseline in Mean Scores in UCLA Loneliness Scale at 6 Months Post-Intervention Completion

    UCLA Loneliness Scale has a range of 20 to 80, where higher scores indicate greater loneliness. The questions ask about how often participants feel lacking in companionship, left out, or isolated from others.

    Measured: Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline)

  64. Change from Baseline in Mean Scores in UCLA Loneliness Scale at 12 Months Post-Intervention Completion

    UCLA Loneliness Scale has a range of 20 to 80, where higher scores indicate greater loneliness. The questions ask about how often participants feel lacking in companionship, left out, or isolated from others.

    Measured: Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)

  65. Change from Baseline in Mean Scores in UCLA Loneliness Scale at 24 Months Post-Intervention Completion

    UCLA Loneliness Scale has a range of 20 to 80, where higher scores indicate greater loneliness. The questions ask about how often participants feel lacking in companionship, left out, or isolated from others.

    Measured: Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)

  66. Difference in Mean Scores in UCLA Loneliness Scale Between the Experimental Arm and the Active Control Arm Midway Through the Intervention

    UCLA Loneliness Scale has a range of 20 to 80, where higher scores indicate greater loneliness. The questions ask about how often participants feel lacking in companionship, left out, or isolated from others. 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

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

  67. Difference in Mean Scores in UCLA Loneliness Scale Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention

    UCLA Loneliness Scale has a range of 20 to 80, where higher scores indicate greater loneliness. The questions ask about how often participants feel lacking in companionship, left out, or isolated from others. 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

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

  68. Difference in Mean Scores in UCLA Loneliness Scale Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion

    UCLA Loneliness Scale has a range of 20 to 80, where higher scores indicate greater loneliness. The questions ask about how often participants feel lacking in companionship, left out, or isolated from others. 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

    Measured: Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline)

  69. Difference in Mean Scores in UCLA Loneliness Scale Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion

    UCLA Loneliness Scale has a range of 20 to 80, where higher scores indicate greater loneliness. The questions ask about how often participants feel lacking in companionship, left out, or isolated from others. 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

    Measured: Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)

  70. Difference in Mean Scores in UCLA Loneliness Scale Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion

    UCLA Loneliness Scale has a range of 20 to 80, where higher scores indicate greater loneliness. The questions ask about how often participants feel lacking in companionship, left out, or isolated from others. 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

    Measured: Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)

  71. Change from Baseline in Mean Scores in Pain Self-Efficacy Questionnaire Midway Through the Intervention

    Pain Self-Efficacy Questionnaire (PSEQ) has a range of 0 to 60, where higher scores indicate greater confidence in the ability to perform activities despite pain. The questions ask about how certain participants feel they can manage daily tasks, work, and social activities while living with pain.

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

  72. Change from Baseline in Mean Scores in Pain Self-Efficacy Questionnaire at 3 Weeks Post-Intervention

    Pain Self-Efficacy Questionnaire (PSEQ) has a range of 0 to 60, where higher scores indicate greater confidence in the ability to perform activities despite pain. The questions ask about how certain participants feel they can manage daily tasks, work, and social activities while living with pain.

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

  73. Change from Baseline in Mean Scores in Pain Self-Efficacy Questionnaire at 6 Months Post-Intervention Completion

    Pain Self-Efficacy Questionnaire (PSEQ) has a range of 0 to 60, where higher scores indicate greater confidence in the ability to perform activities despite pain. The questions ask about how certain participants feel they can manage daily tasks, work, and social activities while living with pain.

    Measured: Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline)

  74. Change from Baseline in Mean Scores in Pain Self-Efficacy Questionnaire at 12 Months Post-Intervention Completion

    Pain Self-Efficacy Questionnaire (PSEQ) has a range of 0 to 60, where higher scores indicate greater confidence in the ability to perform activities despite pain. The questions ask about how certain participants feel they can manage daily tasks, work, and social activities while living with pain.

    Measured: Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)

  75. Change from Baseline in Mean Scores in Pain Self-Efficacy Questionnaire at 24 Months Post-Intervention Completion

    Pain Self-Efficacy Questionnaire (PSEQ) has a range of 0 to 60, where higher scores indicate greater confidence in the ability to perform activities despite pain. The questions ask about how certain participants feel they can manage daily tasks, work, and social activities while living with pain.

    Measured: Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)

  76. Difference in Mean Scores in Pain Self-Efficacy Questionnaire Between the Experimental Arm and the Active Control Arm Midway Through the Intervention

    Pain Self-Efficacy Questionnaire (PSEQ) has a range of 0 to 60, where higher scores indicate greater confidence in the ability to perform activities despite pain. The questions ask about how certain participants feel they can manage daily tasks, work, and social activities while living with pain. 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

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

  77. Difference in Mean Scores in Pain Self-Efficacy Questionnaire Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention

    Pain Self-Efficacy Questionnaire (PSEQ) has a range of 0 to 60, where higher scores indicate greater confidence in the ability to perform activities despite pain. The questions ask about how certain participants feel they can manage daily tasks, work, and social activities while living with pain. 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

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

  78. Difference in Mean Scores in Pain Self-Efficacy Questionnaire Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion

    Pain Self-Efficacy Questionnaire (PSEQ) has a range of 0 to 60, where higher scores indicate greater confidence in the ability to perform activities despite pain. The questions ask about how certain participants feel they can manage daily tasks, work, and social activities while living with pain. 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

    Measured: Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline)

  79. Difference in Mean Scores in Pain Self-Efficacy Questionnaire Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion

    Pain Self-Efficacy Questionnaire (PSEQ) has a range of 0 to 60, where higher scores indicate greater confidence in the ability to perform activities despite pain. The questions ask about how certain participants feel they can manage daily tasks, work, and social activities while living with pain. 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

    Measured: Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)

  80. Difference in Mean Scores in Pain Self-Efficacy Questionnaire Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion

    Pain Self-Efficacy Questionnaire (PSEQ) has a range of 0 to 60, where higher scores indicate greater confidence in the ability to perform activities despite pain. The questions ask about how certain participants feel they can manage daily tasks, work, and social activities while living with pain. 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

    Measured: Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)

  81. Change from Baseline in Mean Scores in PHQ-8 Midway Through the 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.

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

  82. Change from Baseline in Mean Scores in PHQ-8 at 3 Weeks 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.

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

  83. Change from Baseline in Mean Scores in PHQ-8 at 12 Months Post-Intervention Completion

    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.

    Measured: Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)

  84. Change from Baseline in Mean Scores in PHQ-8 at 24 Months Post-Intervention Completion

    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.

    Measured: Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)

  85. Difference in Mean Scores in PHQ-8 Between the Experimental Arm and the Active Control Arm Midway Through the 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 between the experimental arm and the active control arm to establish whether or not there is a clinical significant difference between arms

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

  86. Difference in Mean Scores in PHQ-8 Between the Experimental Arm and the Active Control Arm at 3 Weeks 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 between the experimental arm and the active control arm to establish whether or not there is a clinical significant difference between arms

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

  87. Difference in Mean Scores in PHQ-8 Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion

    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 between the experimental arm and the active control arm to establish whether or not there is a clinical significant difference between arms

    Measured: Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)

  88. Difference in Mean Scores in PHQ-8 Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion

    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 between the experimental arm and the active control arm to establish whether or not there is a clinical significant difference between arms

    Measured: Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)

  89. Change from Baseline in Mean Scores in GAD-7 Midway Through the 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.

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

  90. Change from Baseline in Mean Scores in GAD-7 at 3 Weeks 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.

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

  91. Change from Baseline in Mean Scores in GAD-7 at 12 Months Post-Intervention Completion

    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.

    Measured: Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)

  92. Change from Baseline in Mean Scores in GAD-7 at 24 Months Post-Intervention Completion

    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.

    Measured: Baseline, 24 Months Post-Intervention Completion(113 weeks after baseline)

  93. Difference in Mean Scores in GAD-7 Between the Experimental Arm and the Active Control Arm Midway Through the 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

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

  94. Difference in Mean Scores in GAD-7 Between the Experimental Arm and the Active Control Arm at 3 Weeks 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

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

  95. Difference in Mean Scores in GAD-7 Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion

    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

    Measured: Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)

  96. Difference in Mean Scores in GAD-7 Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion

    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

    Measured: Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2025
  2. Study start12 Jan 2026
  3. Primary completionDec 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07222696
Sponsor's protocol ID
25-05028875
Status last verified
Jan 2026
First submitted
28 Oct 2025
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All of the individual participant data collected during the trial, after deidentification will be shared upon reasonable request and with a proposal.

Publications

  • Little RJ, Wang Y. Pattern-mixture models for multivariate incomplete data with covariates. Biometrics. 1996 Mar;52(1):98-111.

    PubMed 8934587

  • Royston P, White IR. Multiple imputation by chained equations (MICE): implementation in Stata. Journal of statistical software. 2011;45:1-20

  • McCurry SM, Von Korff M, Vitiello MV, Saunders K, Balderson BH, Moore AL, Rybarczyk BD. Frequency of comorbid insomnia, pain, and depression in older adults with osteoarthritis: predictors of enrollment in a randomized treatment trial. J Psychosom Res. 2011 Nov;71(5):296-9. doi: 10.1016/j.jpsychores.2011.05.012. Epub 2011 Jul 1.

    PubMed 21999972

  • Vasiliadis HM, Chudzinski V, Gontijo-Guerra S, Preville M. Screening instruments for a population of older adults: The 10-item Kessler Psychological Distress Scale (K10) and the 7-item Generalized Anxiety Disorder Scale (GAD-7). Psychiatry Res. 2015 Jul 30;228(1):89-94. doi: 10.1016/j.psychres.2015.04.019. Epub 2015 Apr 23.

    PubMed 25956759

  • Osman A, Barrios FX, Kopper BA, Hauptmann W, Jones J, O'Neill E. Factor structure, reliability, and validity of the Pain Catastrophizing Scale. J Behav Med. 1997 Dec;20(6):589-605. doi: 10.1023/a:1025570508954.

    PubMed 9429990

  • Toussaint A, Husing P, Gumz A, Wingenfeld K, Harter M, Schramm E, Lowe B. Sensitivity to change and minimal clinically important difference of the 7-item Generalized Anxiety Disorder Questionnaire (GAD-7). J Affect Disord. 2020 Mar 15;265:395-401. doi: 10.1016/j.jad.2020.01.032. Epub 2020 Jan 15.

    PubMed 32090765

  • Kounali D, Button KS, Lewis G, Gilbody S, Kessler D, Araya R, Duffy L, Lanham P, Peters TJ, Wiles N, Lewis G. How much change is enough? Evidence from a longitudinal study on depression in UK primary care. Psychol Med. 2022 Jul;52(10):1875-1882. doi: 10.1017/S0033291720003700. Epub 2020 Nov 3.

    PubMed 33138872

  • Bauer-Staeb C, Kounali DZ, Welton NJ, Griffith E, Wiles NJ, Lewis G, Faraway JJ, Button KS. Effective dose 50 method as the minimal clinically important difference: Evidence from depression trials. J Clin Epidemiol. 2021 Sep;137:200-208. doi: 10.1016/j.jclinepi.2021.04.002. Epub 2021 Apr 20.

    PubMed 33892086

  • Safford MM, Cummings DM, Halladay JR, Shikany JM, Richman J, Oparil S, Hollenberg J, Adams A, Anabtawi M, Andreae L, Baquero E, Bryan J, Sanders-Clark D, Johnson E, Richman E, Soroka O, Tillman J, Cherrington AL. Practice Facilitation and Peer Coaching for Uncontrolled Hypertension Among Black Individuals: A Randomized Clinical Trial. JAMA Intern Med. 2024 May 1;184(5):538-546. doi: 10.1001/jamainternmed.2024.0047.

    PubMed 38497987

  • Safford MM, Andreae S, Cherrington AL, Martin MY, Halanych J, Lewis M, Patel A, Johnson E, Clark D, Gamboa C, Richman JS. Peer Coaches to Improve Diabetes Outcomes in Rural Alabama: A Cluster Randomized Trial. Ann Fam Med. 2015 Aug;13 Suppl 1(Suppl 1):S18-26. doi: 10.1370/afm.1798.

    PubMed 26304967

  • Richman JS, Andreae S, Safford MM. Challenges of Prolonged Follow-up and Temporal Imbalance in Pragmatic Trials: Analysis of the ENCOURAGE Trial. Ann Fam Med. 2015 Aug;13 Suppl 1(Suppl 1):S66-72. doi: 10.1370/afm.1790.

    PubMed 26304974

  • Guideline Development Panel for the Treatment of Depressive Disorders. Summary of the clinical practice guideline for the treatment of depression across three age cohorts. Am Psychol. 2022 Sep;77(6):770-780. doi: 10.1037/amp0000904. Epub 2021 Nov 29.

    PubMed 34843274

  • Salvi J. Calculated Decisions: Columbia-Suicide Severity Rating Scale (C-SSRS). Emerg Med Pract. 2019 May 1;21(5):CD3-4.

    PubMed 31039299

  • Pedersen JK, Wang L, Risbo N, Pedersen AB, Andersen K, Ellingsen T. Mortality in patients with incident rheumatoid arthritis and depression: a Danish cohort study of 11 071 patients and 55 355 comparators. Rheumatology (Oxford). 2024 Mar 1;63(3):680-688. doi: 10.1093/rheumatology/kead259.

    PubMed 37252810

  • Heidari P, Cross W, Crawford K. Do out-of-pocket costs affect medication adherence in adults with rheumatoid arthritis? A systematic review. Semin Arthritis Rheum. 2018 Aug;48(1):12-21. doi: 10.1016/j.semarthrit.2017.12.010. Epub 2018 Jan 8.

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Questions about this trial

What is this clinical trial studying?

A study testing Peer Coach and Healthy Horizons in people with Rheumatoid Arthritis (RA, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Iris Navarro-Millán, MD, MPH (205-529-2978, yin9003@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07222696, which also lists 49 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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