Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthier | Experimental | Participants will have 9 telephone-delivered sessions, over a 9-12-week period, delivered by a peer coach (another person with RA). Data will be collected at baseline, midway through the intervention (after Session 4 of the intervention), 3 weeks after completion of the intervention, 6, 12, and 24 months after completion of the intervention using validated instruments. |
|
| Healthy Horizons | Active Comparator | Participants from will have 9 telephone-delivered sessions over a 9-12-week period delivered by a coach (a person without RA but who has a different chronic condition like osteoarthritis or diabetes). Data will be collected at baseline, midway through the intervention (after Session 4 of the intervention), 3 weeks after completion of the intervention, 6, 12, and 24 months after completion of the intervention using validated instruments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Coach | Behavioral | The method that will be used in this trial will be peer coaching. Peer coaches are lay individuals who themselves have the targeted chronic condition, that for the purpose of this study is people with RA, allowing people to identify with their peers and increase confidence that they too can achieve favorable outcomes. They will use components of CBT, mindfulness, and exercise material that have been effective in improving mental and physical health in patients with RA. The Healthier intervention is distinct from these others because it focuses on a high-priority symptom experienced by people with RA: chronic pain. It mobilizes a behavior that impacts numerous dimensions beyond pain, including mobility, mood, cardiovascular health, and mortality. |
| 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) |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Iris Navarro-Millán, MD, MPH | Contact | 205-529-2978 | yin9003@med.cornell.edu | |
| Sarah Young, PhD | Contact | 646-962-8033 | say4011@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Iris Y Navarro-Millán, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College | Recruiting | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8934587 | Background | Little RJ, Wang Y. Pattern-mixture models for multivariate incomplete data with covariates. Biometrics. 1996 Mar;52(1):98-111. | |
| Background | Royston P, White IR. Multiple imputation by chained equations (MICE): implementation in Stata. Journal of statistical software. 2011;45:1-20 | ||
| 21999972 |
Not provided
Not provided
All of the individual participant data collected during the trial, after deidentification will be shared upon reasonable request and with a proposal.
Data will be available beginning 9 months following the last data collection and ending 72 months following publication.
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.
Not provided
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D000092862 | Psychological Well-Being |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Healthy Horizons | Behavioral | Participants in the active comparator arm will have telephone calls with a coach that does not have rheumatoid arthritis and who will deliver a nine-session intervention on general health topics that are widely available including topics on nutrition and cancer awareness. These coaches will not use CBT, mindfulness or make any references to exercise or physical activity. |
|
| 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) |
| Background |
| 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. |
| 25956759 | Background | 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. |
| 9429990 | Background | 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. |
| 32090765 | Background | 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. |
| 33138872 | Background | 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. |
| 33892086 | Background | 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. |
| 38497987 | Background | 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. |
| 26304967 | Background | 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. |
| 26304974 | Background | 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. |
| 34843274 | Background | 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. |
| 31039299 | Background | Salvi J. Calculated Decisions: Columbia-Suicide Severity Rating Scale (C-SSRS). Emerg Med Pract. 2019 May 1;21(5):CD3-4. |
| 37252810 | Background | 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. |
| 29496225 | Background | 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. |
| 21671414 | Background | Barton JL, Trupin L, Schillinger D, Gansky SA, Tonner C, Margaretten M, Chernitskiy V, Graf J, Imboden J, Yelin E. Racial and ethnic disparities in disease activity and function among persons with rheumatoid arthritis from university-affiliated clinics. Arthritis Care Res (Hoboken). 2011 Sep;63(9):1238-46. doi: 10.1002/acr.20525. |
| 33195803 | Background | 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. |
| Background | Moskalenko MY, Hadjistavropoulos HD, Katapally TR. Barriers to patient interest in internet-based cognitive behavioral therapy: Informing e-health policies through quantitative analysis. Health Policy and Technology. 2020/06/01/ 2020;9(2):139-145. https://doi.org/10.1016/j.hlpt.2020.04.004 |
| 29570963 | Background | Wells MJ, Owen JJ, McCray LW, Bishop LB, Eells TD, Brown GK, Richards D, Thase ME, Wright JH. Computer-Assisted Cognitive-Behavior Therapy for Depression in Primary Care: Systematic Review and Meta-Analysis. Prim Care Companion CNS Disord. 2018 Mar 1;20(2):17r02196. doi: 10.4088/PCC.17r02196. |
| 28903893 | Background | Rost T, Stein J, Lobner M, Kersting A, Luck-Sikorski C, Riedel-Heller SG. User Acceptance of Computerized Cognitive Behavioral Therapy for Depression: Systematic Review. J Med Internet Res. 2017 Sep 13;19(9):e309. doi: 10.2196/jmir.7662. |
| 29215315 | Background | 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. |
| 15231555 | Background | 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. |
| 22517917 | Background | 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. |
| 11956035 | Background | Christensen H, Griffiths KM, Korten A. Web-based cognitive behavior therapy: analysis of site usage and changes in depression and anxiety scores. J Med Internet Res. 2002 Jan-Mar;4(1):e3. doi: 10.2196/jmir.4.1.e3. |
| 35442954 | Background | Almohammed OA, Alsalem AA, Almangour AA, Alotaibi LH, Al Yami MS, Lai L. Antidepressants and health-related quality of life (HRQoL) for patients with depression: Analysis of the medical expenditure panel survey from the United States. PLoS One. 2022 Apr 20;17(4):e0265928. doi: 10.1371/journal.pone.0265928. eCollection 2022. |
| 24526928 | Background | Young SD, Zhao M, Teiu K, Kwok J, Gill H, Gill N. A social-media based HIV prevention intervention using peer leaders. J Consum Health Internet. 2013 Oct 1;17(4):353-361. doi: 10.1080/15398285.2013.833445. |
| 8968292 | Background | 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. |
| 11238152 | Background | Shah S, Peat JK, Mazurski EJ, Wang H, Sindhusake D, Bruce C, Henry RL, Gibson PG. Effect of peer led programme for asthma education in adolescents: cluster randomised controlled trial. BMJ. 2001 Mar 10;322(7286):583-5. doi: 10.1136/bmj.322.7286.583. |
| 23553347 | Background | 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. |
| 23508600 | Background | 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. |
| 21220362 | Background | 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. |
| 21292425 | Background | 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. |
| 24722495 | Background | 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. |
| 11148297 | Background | Bandura A. Social cognitive theory: an agentic perspective. Annu Rev Psychol. 2001;52:1-26. doi: 10.1146/annurev.psych.52.1.1. |
| 32129673 | Background | Shen B, Li Y, Du X, Chen H, Xu Y, Li H, Xu GY. Effects of cognitive behavioral therapy for patients with rheumatoid arthritis: a systematic review and meta-analysis. Psychol Health Med. 2020 Dec;25(10):1179-1191. doi: 10.1080/13548506.2020.1736312. Epub 2020 Mar 4. |
| 31957665 | Background | 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. |
| 31937528 | Background | 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. |
| 25422002 | Background | Benatti FB, Pedersen BK. Exercise as an anti-inflammatory therapy for rheumatic diseases-myokine regulation. Nat Rev Rheumatol. 2015 Feb;11(2):86-97. doi: 10.1038/nrrheum.2014.193. Epub 2014 Nov 25. |
| 18790313 | Background | 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. |
| 22660945 | Background | Meerwijk EL, Ford JM, Weiss SJ. Brain regions associated with psychological pain: implications for a neural network and its relationship to physical pain. Brain Imaging Behav. 2013 Mar;7(1):1-14. doi: 10.1007/s11682-012-9179-y. |
| 28706741 | Background | 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. |
| 17552045 | Background | Bruce B, Fries JF, Murtagh KN. Health status disparities in ethnic minority patients with rheumatoid arthritis: a cross-sectional study. J Rheumatol. 2007 Jul;34(7):1475-9. Epub 2007 Jun 1. |
| 32911290 | Background | Navarro-Millan I, Rajan M, Lui GE, Kern LM, Pinheiro LC, Safford MM, Sattui SE, Curtis JR. Racial and ethnic differences in medication use among beneficiaries of social security disability insurance with rheumatoid arthritis. Semin Arthritis Rheum. 2020 Oct;50(5):988-995. doi: 10.1016/j.semarthrit.2020.07.008. Epub 2020 Jul 23. |
| 33394602 | Background | Yip K, Navarro-Millan I. Racial, ethnic, and healthcare disparities in rheumatoid arthritis. Curr Opin Rheumatol. 2021 Mar 1;33(2):117-121. doi: 10.1097/BOR.0000000000000782. |
| 18971402 | Background | Alegria M, Chatterji P, Wells K, Cao Z, Chen CN, Takeuchi D, Jackson J, Meng XL. Disparity in depression treatment among racial and ethnic minority populations in the United States. Psychiatr Serv. 2008 Nov;59(11):1264-72. doi: 10.1176/ps.2008.59.11.1264. |
| 31673680 | Background | Peterson S, Piercy J, Blackburn S, Sullivan E, Karyekar CS, Li N. The multifaceted impact of anxiety and depression on patients with rheumatoid arthritis. BMC Rheumatol. 2019 Oct 28;3:43. doi: 10.1186/s41927-019-0092-5. eCollection 2019. |
| 24859781 | Background | Anyfanti P, Gavriilaki E, Pyrpasopoulou A, Triantafyllou G, Triantafyllou A, Chatzimichailidou S, Gkaliagkousi E, Aslanidis S, Douma S. Depression, anxiety, and quality of life in a large cohort of patients with rheumatic diseases: common, yet undertreated. Clin Rheumatol. 2016 Mar;35(3):733-9. doi: 10.1007/s10067-014-2677-0. Epub 2014 May 25. |
| 23742957 | Background | Navarro-Millan I, Chen L, Greenberg JD, Pappas DA, Curtis JR. Predictors and persistence of new-onset clinical remission in rheumatoid arthritis patients. Semin Arthritis Rheum. 2013 Oct;43(2):137-43. doi: 10.1016/j.semarthrit.2013.02.002. Epub 2013 Jun 3. |
| 28089982 | Background | Ni Mhuircheartaigh O, Crowson CS, Gabriel SE, Roger VL, Melton LJ 3rd, Amin S. Fragility Fractures Are Associated with an Increased Risk for Cardiovascular Events in Women and Men with Rheumatoid Arthritis: A Population-based Study. J Rheumatol. 2017 May;44(5):558-564. doi: 10.3899/jrheum.160651. Epub 2017 Jan 15. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |