Rheumatoid Arthritis (RA
Conditions
Keywords
Rheumatoid Arthritis, Peer Coaching, Health Coaching, Community-based Intervention, Mental Health, Pain and mood management
Brief summary
The goal of this clinical trial is to learn if peer coaching works to reduce levels of anxiety and/or depression in adults diagnosed with Rheumatoid Arthritis (RA). The main questions it aims to answer are: Do people with RA who complete the intervention with a peer coach have lower levels of anxiety and/or depression at 6 months from baseline? Do people with RA who complete the intervention with a peer coach have lower levels of anxiety and/or depression at 6 months compared to those in the control arm? Researchers will compare the peer coaching intervention to an active-control arm (where people without RA coach participants on general health and nutrition topics) to see if peer coaching works to reduce anxiety and/or depression. Participants will meet with a coach every week for 9 weeks and complete several surveys before, during and after the intervention
Interventions
BEHAVIORALPeer 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.
BEHAVIORALHealthy 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.
Sponsors
Weill Medical College of Cornell University
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Mean Scores in PHQ-8 at 6 months post intervention | Baseline and 6 months after completing the intervention (35 weeks after baseline) | Patient Health Questionnaire-8 has a range 0-24, where a higher score means more distress. The questions ask about how often participants have been affected by certain events. |
| Difference in Mean Scores in PHQ-8 Between the Experimental Arm and the Active Control Arm at 6 Months Post Intervention | Six months post intervention completion (Approximately 35 weeks after baseline) | Patient Health Questionnaire-8 has a range 0-24, where a higher score means more distress. The questions ask about how often participants have been affected by certain events. We will determine differences in mean scores in PHQ-8 between the experimental arm and the active control arm to establish whether or not there is a clinical significant difference between arms |
| Change from Baseline in Mean Scores in GAD-7 at 6 months post intervention | Baseline and 6 months after completing the intervention (35 weeks after baseline) | General Anxiety Disorder-7 has a range 0-21, where a score of 0-4 means minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety and 15-21 severe anxiety. The questions ask about how often participants have been affected by certain events. |
| Difference in Mean Scores in GAD-7 Between the Experimental Arm and the Active Control Arm at 6 Months Post Intervention | Six months post intervention completion (35 weeks after baseline) | General Anxiety Disorder-7 has a range 0-21, where a score of 0-4 means minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety and 15-21 severe anxiety. The questions ask about how often participants have been affected by certain events. We will determine differences in mean scores between the experimental arm and the active control arm to establish whether or not there is a clinical significant difference between arms, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Mean Scores in PROMIS Pain Interference Midway Through the Intervention | Baseline, Midway through the intervention (4 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in PROMIS Pain Interference at 3 Weeks Post-Intervention | Baseline, 3 Weeks Post-Intervention (12 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in PROMIS Pain Interference at 6 Months Post-Intervention Completion | Baseline, 6 months post intervention completion (35 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in PROMIS Pain Interference at 12 Months Post-Intervention Completion | Baseline, 12 months post-intervention completion (61 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in PROMIS Pain Interference at 24 Months Post-Intervention Completion | Baseline, 24 months post-intervention completion (113 weeks after baseline) | 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. |
| Difference in Mean Scores in PROMIS Pain Interference Between the Experimental Arm and the Active Control Arm Midway Through the Intervention | Baseline, Midway through the intervention (4 weeks after baseline) | 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 |
| Difference in Mean Scores in PROMIS Pain Interference Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention | Baseline, 3 Weeks Post-Intervention(12 weeks after baseline) | 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 |
| Difference in Mean Scores in PROMIS Pain Interference Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion | Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline) | 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 |
| Difference in Mean Scores in PROMIS Pain Interference Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion | Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline) | 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 |
| Difference in Mean Scores in PROMIS Pain Interference Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion | Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline) | 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 |
| Change from Baseline in Mean Scores in PROMIS Sleep Disturbance Midway Through the Intervention | Baseline, Midway through the intervention (4 weeks after baseline) | 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.. |
| Change from Baseline in Mean Scores in PROMIS Sleep Disturbance at 3 Weeks Post-Intervention | Baseline, 3 Weeks Post-Intervention (12 weeks after baseline) | 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.. |
| Change from Baseline in Mean Scores in PROMIS Sleep Disturbance at 6 Months Post-Intervention Completion | Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline) | 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.. |
| Change from Baseline in Mean Scores in PROMIS Sleep Disturbance at 12 Months Post-Intervention Completion | Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline) | 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.. |
| Change from Baseline in Mean Scores in PROMIS Sleep Disturbance at 24 Months Post-Intervention Completion | Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline) | 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.. |
| Difference in Mean Scores in PROMIS Sleep Disturbance Between the Experimental Arm and the Active Control Arm Midway Through the Intervention | Baseline, Midway through the intervention (4 weeks after baseline) | 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 |
| Difference in Mean Scores in PROMIS Sleep Disturbance Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention | Baseline, 3 Weeks Post-Intervention (12 weeks after baseline) | 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 |
| Difference in Mean Scores in PROMIS Sleep Disturbance Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion | Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline) | 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 |
| Difference in Mean Scores in PROMIS Sleep Disturbance Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion | Baseline, 12 Months Post-Intervention Completion(61 weeks after baseline) | 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 |
| Difference in Mean Scores in PROMIS Sleep Disturbance Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion | Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline) | 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 |
| Change from Baseline in Mean Scores in Short Form-12 Midway Through the Intervention | Baseline, Midway through the intervention (4 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in Short Form-12 at 3 Weeks Post-Intervention | Baseline, 3 Weeks Post-Intervention(12 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in Short Form-12 at 6 Months Post-Intervention Completion | Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in Short Form-12 at 12 Months Post-Intervention Completion | Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in Short Form-12 at 24 Months Post-Intervention Completion | Baseline, 24 Months Post-Intervention Completion(113 weeks after baseline) | 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. |
| Difference in Mean Scores in Short-Form 12 Between the Experimental Arm and the Active Control Arm Midway Through the Intervention | Baseline, Midway Through the intervention(4 weeks after baseline) | 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. |
| Difference in Mean Scores in Short-Form 12 Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention | Baseline, 3 Weeks Post-Intervention(12 weeks after baseline) | 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. |
| Difference in Mean Scores in Short-Form 12 Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion | Baseline, 6 Months Post-Intervention Completion(35 weeks after baseline) | 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. |
| Difference in Mean Scores in Short-Form 12 Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion | Baseline, 12 Months Post-Intervention Completion(61 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in Lubben Social Isolation Midway Through the Intervention | Baseline, Midway through the intervention( 4 weeks after baseline) | 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. |
| Difference in Mean Scores in Short-Form 12 Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion | Baseline, 24 Months Post-Intervention Completion(113 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in PROMIS Physical Function Midway Through the Intervention | Baseline, Midway Through the Intervention (4 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in PROMIS Physical Function at 3 Weeks Post-Intervention | Baseline, 3 Weeks Post-Intervention(12 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in PROMIS Physical Function at 6 Months Post-Intervention Completion | Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in PROMIS Physical Function at 12 Months Post-Intervention Completion | Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in PROMIS Physical Function at 24 Months Post-Intervention Completion | Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline) | 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. |
| Difference in Mean Scores in PROMIS Physical Function Between the Experimental Arm and the Active Control Arm Midway Through the Intervention | Baseline, Midway through the intervention (4 weeks after baseline) | 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 |
| Difference in Mean Scores in PROMIS Physical Function Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention | Baseline, 3 Weeks Post-Intervention(12 weeks after baseline) | 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 |
| Difference in Mean Scores in PROMIS Physical Function Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion | Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline) | 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 |
| Difference in Mean Scores in PROMIS Physical Function Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion | Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline) | 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 |
| Difference in Mean Scores in PROMIS Physical Function Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completionn | Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline) | 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 |
| Change from Baseline in Mean Scores in Lubben Social Isolation at 3 Weeks Post-Intervention | Baseline, 3 Weeks Post-Intervention( 12 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in Lubben Social Isolation at 6 Months Post-Intervention Completion | Baseline, 6 Months Post-Intervention Completion( 35 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in Lubben Social Isolation at 12 Months Post-Intervention Completion | Baseline, 12 Months Post-Intervention Completion( 61 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in Lubben Social Isolation at 24 Months Post-Intervention Completion | Baseline, 24 Months Post-Intervention Completion( 113 weeks after baseline) | 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. |
| Difference in Mean Scores in Lubben Social Isolation Between the Experimental Arm and the Active Control Arm Midway Through the Intervention | Baseline, Midway through the intervention(4 weeks after baseline) | 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 |
| Difference in Mean Scores in Lubben Social Isolation Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention | Baseline, 3 Weeks Post-Intervention(12 weeks after baseline) | 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 |
| Difference in Mean Scores in Lubben Social Isolation Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion | Baseline, 6 Months Post-Intervention Completion(35 weeks after baseline) | 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 |
| Difference in Mean Scores in Lubben Social Isolation Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion | Baseline, 12 Months Post-Intervention Completion(61 weeks after baseline) | 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 |
| Difference in Mean Scores in Lubben Social Isolation Between the Experimental Arm and the Active Control Arm 24 Months Post-Intervention Completion | Baseline, 24 Months Post-Intervention Completion(113 weeks after baseline) | 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 |
| Change from Baseline in Mean Scores in Cohen Stress Scale Midway Through the Intervention | Baseline, Midway through the intervention(4 weeks after baseline) | 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 |
| Change from Baseline in Mean Scores in Cohen Stress Scale at 3 Weeks Post-Intervention | Baseline, 3 Weeks Post-Intervention(12 weeks after baseline) | 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 |
| Change from Baseline in Mean Scores in Cohen Stress Scale at 6 Months Post-Intervention Completion | Baseline, 6 Months Post-Intervention Completion(35 weeks after baseline) | 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 |
| Change from Baseline in Mean Scores in Cohen Stress Scale at 12 Months Post-Intervention Completion | Baseline, 12 Months Post-Intervention Completion(61 weeks after baseline) | 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 |
| Change from Baseline in Mean Scores in Cohen Stress Scale at 24 Months Post-Intervention Completion | Baseline, 24 Months Post-Intervention Completion(113 weeks after baseline) | 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 |
| Difference in Mean Scores in Cohen Stress Scale Between the Experimental Arm and the Active Control Arm Midway Through the Intervention | Baseline, Midway through the intervention (4 weeks after baseline) | 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 |
| Difference in Mean Scores in Cohen Stress Scale Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention | Baseline, 3 Weeks Post-Intervention (12 weeks after baseline) | 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 |
| Difference in Mean Scores in Cohen Stress Scale Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion | Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline) | 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 |
| Difference in Mean Scores in Cohen Stress Scale Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion | Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline) | 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 |
| Difference in Mean Scores in Cohen Stress Scale Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion | Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline) | 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 |
| Change from Baseline in Mean Scores in UCLA Loneliness Scale Midway Through the Intervention | Baseline, Midway through the intervention (4 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in UCLA Loneliness Scale at 3 Weeks Post-Intervention | Baseline, 3 Weeks Post-Intervention (12 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in UCLA Loneliness Scale at 6 Months Post-Intervention Completion | Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in UCLA Loneliness Scale at 12 Months Post-Intervention Completion | Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in UCLA Loneliness Scale at 24 Months Post-Intervention Completion | Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline) | 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. |
| Difference in Mean Scores in UCLA Loneliness Scale Between the Experimental Arm and the Active Control Arm Midway Through the Intervention | Baseline, Midway through the intervention (4 weeks after baseline) | 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 |
| Difference in Mean Scores in UCLA Loneliness Scale Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention | Baseline, 3 Weeks Post-Intervention (12 weeks after baseline) | 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 |
| Difference in Mean Scores in UCLA Loneliness Scale Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion | Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline) | 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 |
| Difference in Mean Scores in UCLA Loneliness Scale Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion | Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline) | 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 |
| Difference in Mean Scores in UCLA Loneliness Scale Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion | Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline) | 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 |
| Change from Baseline in Mean Scores in Pain Self-Efficacy Questionnaire Midway Through the Intervention | Baseline, Midway through the intervention (4 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in Pain Self-Efficacy Questionnaire at 3 Weeks Post-Intervention | Baseline, 3 Weeks Post-Intervention (12 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in Pain Self-Efficacy Questionnaire at 6 Months Post-Intervention Completion | Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in Pain Self-Efficacy Questionnaire at 12 Months Post-Intervention Completion | Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline) | 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. |
| Change from Baseline in Mean Scores in Pain Self-Efficacy Questionnaire at 24 Months Post-Intervention Completion | Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline) | 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. |
| Difference in Mean Scores in Pain Self-Efficacy Questionnaire Between the Experimental Arm and the Active Control Arm Midway Through the Intervention | Baseline, Midway through the intervention (4 weeks after baseline) | 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 |
| Difference in Mean Scores in Pain Self-Efficacy Questionnaire Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention | Baseline, 3 Weeks Post-Intervention (12 weeks after baseline) | 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 |
| Difference in Mean Scores in Pain Self-Efficacy Questionnaire Between the Experimental Arm and the Active Control Arm at 6 Months Post-Intervention Completion | Baseline, 6 Months Post-Intervention Completion (35 weeks after baseline) | 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 |
| Difference in Mean Scores in Pain Self-Efficacy Questionnaire Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion | Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline) | 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 |
| Difference in Mean Scores in Pain Self-Efficacy Questionnaire Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion | Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline) | 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 |
| Change from Baseline in Mean Scores in PHQ-8 Midway Through the Intervention | Baseline, Midway through the intervention (4 weeks after baseline) | Patient Health Questionnaire-8 has a range 0-24, where a higher score means more distress. The questions ask about how often participants have been affected by certain events. |
| Change from Baseline in Mean Scores in PHQ-8 at 3 Weeks Post-Intervention | Baseline, 3 Weeks Post-Intervention (12 weeks after baseline) | Patient Health Questionnaire-8 has a range 0-24, where a higher score means more distress. The questions ask about how often participants have been affected by certain events. |
| Change from Baseline in Mean Scores in PHQ-8 at 12 Months Post-Intervention Completion | Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline) | Patient Health Questionnaire-8 has a range 0-24, where a higher score means more distress. The questions ask about how often participants have been affected by certain events. |
| Change from Baseline in Mean Scores in PHQ-8 at 24 Months Post-Intervention Completion | Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline) | Patient Health Questionnaire-8 has a range 0-24, where a higher score means more distress. The questions ask about how often participants have been affected by certain events. |
| Difference in Mean Scores in PHQ-8 Between the Experimental Arm and the Active Control Arm Midway Through the Intervention | Baseline, Midway through the intervention (4 weeks after baseline) | Patient Health Questionnaire-8 has a range 0-24, where a higher score means more distress. The questions ask about how often participants have been affected by certain events. We will determine differences in mean scores between the experimental arm and the active control arm to establish whether or not there is a clinical significant difference between arms |
| Difference in Mean Scores in PHQ-8 Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention | Baseline, 3 Weeks Post-Intervention (12 weeks after baseline) | Patient Health Questionnaire-8 has a range 0-24, where a higher score means more distress. The questions ask about how often participants have been affected by certain events. We will determine differences in mean scores between the experimental arm and the active control arm to establish whether or not there is a clinical significant difference between arms |
| Difference in Mean Scores in PHQ-8 Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion | Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline) | Patient Health Questionnaire-8 has a range 0-24, where a higher score means more distress. The questions ask about how often participants have been affected by certain events. We will determine differences in mean scores between the experimental arm and the active control arm to establish whether or not there is a clinical significant difference between arms |
| Difference in Mean Scores in PHQ-8 Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion | Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline) | Patient Health Questionnaire-8 has a range 0-24, where a higher score means more distress. The questions ask about how often participants have been affected by certain events. We will determine differences in mean scores between the experimental arm and the active control arm to establish whether or not there is a clinical significant difference between arms |
| Change from Baseline in Mean Scores in GAD-7 Midway Through the Intervention | Baseline, Midway through the intervention (4 weeks after baseline) | General Anxiety Disorder-7 has a range 0-21, where a score of 0-4 means minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety and 15-21 severe anxiety. The questions ask about how often participants have been affected by certain events. |
| Change from Baseline in Mean Scores in GAD-7 at 3 Weeks Post-Intervention | Baseline, 3 Weeks Post-Intervention (12 weeks after baseline) | General Anxiety Disorder-7 has a range 0-21, where a score of 0-4 means minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety and 15-21 severe anxiety. The questions ask about how often participants have been affected by certain events. |
| Change from Baseline in Mean Scores in GAD-7 at 12 Months Post-Intervention Completion | Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline) | General Anxiety Disorder-7 has a range 0-21, where a score of 0-4 means minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety and 15-21 severe anxiety. The questions ask about how often participants have been affected by certain events. |
| Change from Baseline in Mean Scores in GAD-7 at 24 Months Post-Intervention Completion | Baseline, 24 Months Post-Intervention Completion(113 weeks after baseline) | General Anxiety Disorder-7 has a range 0-21, where a score of 0-4 means minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety and 15-21 severe anxiety. The questions ask about how often participants have been affected by certain events. |
| Difference in Mean Scores in GAD-7 Between the Experimental Arm and the Active Control Arm Midway Through the Intervention | Baseline, Midway through the intervention (4 weeks after baseline) | General Anxiety Disorder-7 has a range 0-21, where a score of 0-4 means minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety and 15-21 severe anxiety. The questions ask about how often participants have been affected by certain events. We will determine differences in mean scores between the experimental arm and the active control arm to establish whether or not there is a clinical significant difference between arms |
| Difference in Mean Scores in GAD-7 Between the Experimental Arm and the Active Control Arm at 3 Weeks Post-Intervention | Baseline, 3 Weeks Post-Intervention (12 weeks after baseline) | General Anxiety Disorder-7 has a range 0-21, where a score of 0-4 means minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety and 15-21 severe anxiety. The questions ask about how often participants have been affected by certain events. We will determine differences in mean scores between the experimental arm and the active control arm to establish whether or not there is a clinical significant difference between arms |
| Difference in Mean Scores in GAD-7 Between the Experimental Arm and the Active Control Arm at 12 Months Post-Intervention Completion | Baseline, 12 Months Post-Intervention Completion (61 weeks after baseline) | General Anxiety Disorder-7 has a range 0-21, where a score of 0-4 means minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety and 15-21 severe anxiety. The questions ask about how often participants have been affected by certain events. We will determine differences in mean scores between the experimental arm and the active control arm to establish whether or not there is a clinical significant difference between arms |
| Difference in Mean Scores in GAD-7 Between the Experimental Arm and the Active Control Arm at 24 Months Post-Intervention Completion | Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline) | General Anxiety Disorder-7 has a range 0-21, where a score of 0-4 means minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety and 15-21 severe anxiety. The questions ask about how often participants have been affected by certain events. We will determine differences in mean scores between the experimental arm and the active control arm to establish whether or not there is a clinical significant difference between arms |
Countries
United States
Contacts
CONTACTIris Navarro-Millán, MD, MPH
CONTACTSarah Young, PhD
PRINCIPAL_INVESTIGATORIris Y Navarro-Millán, MD
Weill Medical College of Cornell University
Outcome results
None listed