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

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

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis (RA
• Intervention / Treatment: Behavioral: Peer Coach; Behavioral: Healthy Horizons

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Iris Navarro-Millán, MD, MPH; Phone Number: 205-529-2978; Email: yin9003@med.cornell.edu
• Study Contact Backup: Name: Sarah Young, PhD; Phone Number: 646-962-8033; Email: say4011@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medical College
      • Contact: Iris Y Navarro-Millán, MD, MSPH; Phone Number: 646-962-5896; Email: research-rheum@med.cornell.edu
      • Principal Investigator: Iris Navarro-Millán, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or Female older than 18 years of age.
• Have a diagnosis of Rheumatoid Arthritis by a rheumatologist and currently taking a Disease-Modifying Anti-rheumatic drug ( Conventional Disease-Modifying Anti-rheumatic drug and/or Biological Disease-Modifying Anti-rheumatic drug)
• Have high levels of depression defined as PHQ-8 scores between 10 to 20, OR high levels of anxiety based on GAD-7 scores > 10
• Speaks English or Spanish
• Have access to the internet, a computer, and/or a smartphone
• Resides or lives in any state of the US, including Puerto Rico
• Willing to work with a peer coach or a coach

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthier; Participants will have 9 telephone-delivered sessions, over a 9-12-week period, delivered by a peer coach (another person with RA). Data will be collected at baseline, midway through the intervention (after Session 4 of the intervention), 3 weeks after completion of the intervention, 6, 12, and 24 months after completion of the intervention using validated instruments.	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.
Active Comparator: Healthy Horizons; Participants from will have 9 telephone-delivered sessions over a 9-12-week period delivered by a coach (a person without RA but who has a different chronic condition like osteoarthritis or diabetes). Data will be collected at baseline, midway through the intervention (after Session 4 of the intervention), 3 weeks after completion of the intervention, 6, 12, and 24 months after completion of the intervention using validated instruments.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Midway through the intervention (4 weeks after baseline)
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.	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	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.	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	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.	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	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.	Baseline, 24 months post-intervention completion (113 weeks after baseline)
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	Baseline, Midway through the intervention (4 weeks after baseline)
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	Baseline, 3 Weeks Post-Intervention(12 weeks after baseline)
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	Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline)
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	Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)
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	Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)
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..	Baseline, Midway through the intervention (4 weeks after baseline)
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..	Baseline, 3 Weeks Post-Intervention (12 weeks after baseline)
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..	Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline)
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..	Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)
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..	Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)
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	Baseline, Midway through the intervention (4 weeks after baseline)
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	Baseline, 3 Weeks Post-Intervention (12 weeks after baseline)
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	Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline)
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	Baseline, 12 Months Post-Intervention Completion(61 weeks after baseline)
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	Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)
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.	Baseline, Midway through the intervention (4 weeks after baseline)
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.	Baseline, 3 Weeks Post-Intervention(12 weeks after baseline)
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.	Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline)
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.	Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)
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.	Baseline, 24 Months Post-Intervention Completion(113 weeks after baseline)
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.	Baseline, Midway Through the intervention(4 weeks after baseline)
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.	Baseline, 3 Weeks Post-Intervention(12 weeks after baseline)
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.	Baseline, 6 Months Post-Intervention Completion(35 weeks after baseline)
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.	Baseline, 12 Months Post-Intervention Completion(61 weeks after baseline)
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.	Baseline, 24 Months Post-Intervention Completion(113 weeks after baseline)
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.	Baseline, Midway Through the Intervention (4 weeks after baseline)
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.	Baseline, 3 Weeks Post-Intervention(12 weeks after baseline)
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.	Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline)
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.	Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)
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.	Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)
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	Baseline, Midway through the intervention (4 weeks after baseline)
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	Baseline, 3 Weeks Post-Intervention(12 weeks after baseline)
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	Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline)
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	Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)
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	Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)
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.	Baseline, Midway through the intervention( 4 weeks after baseline)
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.	Baseline, 3 Weeks Post-Intervention( 12 weeks after baseline)
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.	Baseline, 6 Months Post-Intervention Completion( 35 weeks after baseline)
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.	Baseline, 12 Months Post-Intervention Completion( 61 weeks after baseline)
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.	Baseline, 24 Months Post-Intervention Completion( 113 weeks after baseline)
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	Baseline, Midway through the intervention(4 weeks after baseline)
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	Baseline, 3 Weeks Post-Intervention(12 weeks after baseline)
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	Baseline, 6 Months Post-Intervention Completion(35 weeks after baseline)
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	Baseline, 12 Months Post-Intervention Completion(61 weeks after baseline)
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	Baseline, 24 Months Post-Intervention Completion(113 weeks after baseline)
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	Baseline, Midway through the intervention(4 weeks after baseline)
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	Baseline, 3 Weeks Post-Intervention(12 weeks after baseline)
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	Baseline, 6 Months Post-Intervention Completion(35 weeks after baseline)
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	Baseline, 12 Months Post-Intervention Completion(61 weeks after baseline)
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	Baseline, 24 Months Post-Intervention Completion(113 weeks after baseline)
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	Baseline, Midway through the intervention (4 weeks after baseline)
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	Baseline, 3 Weeks Post-Intervention (12 weeks after baseline)
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	Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline)
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	Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)
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	Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)
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.	Baseline, Midway through the intervention (4 weeks after baseline)
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.	Baseline, 3 Weeks Post-Intervention (12 weeks after baseline)
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.	Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline)
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.	Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)
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.	Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)
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	Baseline, Midway through the intervention (4 weeks after baseline)
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	Baseline, 3 Weeks Post-Intervention (12 weeks after baseline)
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	Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline)
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	Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)
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	Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)
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.	Baseline, Midway through the intervention (4 weeks after baseline)
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.	Baseline, 3 Weeks Post-Intervention (12 weeks after baseline)
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.	Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline)
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.	Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)
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.	Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)
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	Baseline, Midway through the intervention (4 weeks after baseline)
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	Baseline, 3 Weeks Post-Intervention (12 weeks after baseline)
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	Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline)
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	Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)
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	Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)
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.	Baseline, Midway through the intervention (4 weeks after baseline)
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.	Baseline, 3 Weeks Post-Intervention (12 weeks after baseline)
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.	Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)
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.	Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)
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	Baseline, Midway through the intervention (4 weeks after baseline)
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	Baseline, 3 Weeks Post-Intervention (12 weeks after baseline)
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	Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)
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	Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)
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.	Baseline, Midway through the intervention (4 weeks after baseline)
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.	Baseline, 3 Weeks Post-Intervention (12 weeks after baseline)
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.	Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)
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.	Baseline, 24 Months Post-Intervention Completion(113 weeks after baseline)
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	Baseline, Midway through the intervention (4 weeks after baseline)
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	Baseline, 3 Weeks Post-Intervention (12 weeks after baseline)
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	Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline)
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	Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: Iris Y Navarro-Millán, MD, Weill Medical College of Cornell University

Publications and helpful links

General Publications

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• Rahman A, Malik A, Sikander S, Roberts C, Creed F. Cognitive behaviour therapy-based intervention by community health workers for mothers with depression and their infants in rural Pakistan: a cluster-randomised controlled trial. Lancet. 2008 Sep 13;372(9642):902-9. doi: 10.1016/S0140-6736(08)61400-2.
• Thom DH, Ghorob A, Hessler D, De Vore D, Chen E, Bodenheimer TA. Impact of peer health coaching on glycemic control in low-income patients with diabetes: a randomized controlled trial. Ann Fam Med. 2013 Mar-Apr;11(2):137-44. doi: 10.1370/afm.1443.
• Tang TS, Funnell M, Sinco B, Piatt G, Palmisano G, Spencer MS, Kieffer EC, Heisler M. Comparative effectiveness of peer leaders and community health workers in diabetes self-management support: results of a randomized controlled trial. Diabetes Care. 2014 Jun;37(6):1525-34. doi: 10.2337/dc13-2161. Epub 2014 Apr 10.
• Tang TS, Funnell MM, Gillard M, Nwankwo R, Heisler M. The development of a pilot training program for peer leaders in diabetes: process and content. Diabetes Educ. 2011 Jan-Feb;37(1):67-77. doi: 10.1177/0145721710387308. Epub 2011 Jan 10.
• Tang TS, Funnell MM, Gillard M, Nwankwo R, Heisler M. Training peers to provide ongoing diabetes self-management support (DSMS): results from a pilot study. Patient Educ Couns. 2011 Nov;85(2):160-8. doi: 10.1016/j.pec.2010.12.013. Epub 2011 Feb 2.
• Proudfoot J, Ryden C, Everitt B, Shapiro DA, Goldberg D, Mann A, Tylee A, Marks I, Gray JA. Clinical efficacy of computerised cognitive-behavioural therapy for anxiety and depression in primary care: randomised controlled trial. Br J Psychiatry. 2004 Jul;185:46-54. doi: 10.1192/bjp.185.1.46.
• Zhou B, Wang G, Hong Y, Xu S, Wang J, Yu H, Liu Y, Yu L. Mindfulness interventions for rheumatoid arthritis: A systematic review and meta-analysis. Complement Ther Clin Pract. 2020 May;39:101088. doi: 10.1016/j.ctcp.2020.101088. Epub 2020 Jan 11.
• Sheng J, Liu S, Wang Y, Cui R, Zhang X. The Link between Depression and Chronic Pain: Neural Mechanisms in the Brain. Neural Plast. 2017;2017:9724371. doi: 10.1155/2017/9724371. Epub 2017 Jun 19.
• 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.
• Andreae SJ, Andreae LJ, Richman JS, Cherrington AL, Safford MM. Peer-Delivered Cognitive Behavioral Training to Improve Functioning in Patients With Diabetes: A Cluster-Randomized Trial. Ann Fam Med. 2020 Jan;18(1):15-23. doi: 10.1370/afm.2469.
• Horvath KJ, Oakes JM, Rosser BR, Danilenko G, Vezina H, Amico KR, Williams ML, Simoni J. Feasibility, acceptability and preliminary efficacy of an online peer-to-peer social support ART adherence intervention. AIDS Behav. 2013 Jul;17(6):2031-44. doi: 10.1007/s10461-013-0469-1.
• Carlbring P, Andersson G, Cuijpers P, Riper H, Hedman-Lagerlof E. Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: an updated systematic review and meta-analysis. Cogn Behav Ther. 2018 Jan;47(1):1-18. doi: 10.1080/16506073.2017.1401115. Epub 2017 Dec 7.
• Fisher EB Jr, Strunk RC, Sussman LK, Arfken C, Sykes RK, Munro JM, Haywood S, Harrison D, Bascom S. Acceptability and feasibility of a community approach to asthma management: the Neighborhood Asthma Coalition (NAC). J Asthma. 1996;33(6):367-83. doi: 10.3109/02770909609068182.
• 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.
• Merry SN, Stasiak K, Shepherd M, Frampton C, Fleming T, Lucassen MF. The effectiveness of SPARX, a computerised self help intervention for adolescents seeking help for depression: randomised controlled non-inferiority trial. BMJ. 2012 Apr 18;344:e2598. doi: 10.1136/bmj.e2598.
• Little RJ, Wang Y. Pattern-mixture models for multivariate incomplete data with covariates. Biometrics. 1996 Mar;52(1):98-111.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Salvi J. Calculated Decisions: Columbia-Suicide Severity Rating Scale (C-SSRS). Emerg Med Pract. 2019 May 1;21(5):CD3-4.
• 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.
• 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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• Martin A, Chilton J, Paasche C, Nabatkhorian N, Gortler H, Cohenmehr E, Weller I, Amsalem D, Neary S. Shared Living Experiences by Physicians have a Positive Impact on Mental Health Attitudes and Stigma among Medical Students: A Mixed-Methods Study. J Med Educ Curric Dev. 2020 Oct 26;7:2382120520968072. doi: 10.1177/2382120520968072. eCollection 2020 Jan-Dec.
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Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: October 28, 2025
• First Submitted That Met QC Criteria: October 28, 2025
• First Posted (Actual): October 30, 2025

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Mental Health; Rheumatoid Arthritis; Health Coaching; Peer Coaching; Community-based Intervention; Pain and mood management
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pathological Conditions, Signs and Symptoms; Behavior; Skin and Connective Tissue Diseases; Signs and Symptoms; Personal Satisfaction; Pain; Arthritis, Rheumatoid; Psychological Well-Being
• Other Study ID Numbers: 25-05028875

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification will be shared upon reasonable request and with a proposal.
• IPD Sharing Time Frame: Data will be available beginning 9 months following the last data collection and ending 72 months following publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No