Pattern-mixture models for multivariate incomplete data with covariates.
R J Little, Y Wang
https://pubmed.ncbi.nlm.nih.gov/8934587Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07222696
Pilot Randomized Trial of Health Coaching for People With Rheumatoid Arthritis to Improve Mental Well-Being
Led by Weill Medical College of Cornell University · Updated on 2026-01-22
250
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to find out if peer coaching can lower anxiety and depression in adults diagnosed with Rheumatoid Arthritis (RA). It compares the effect of peer coaching, delivered by individuals who also have RA, to coaching from people without RA who discuss general health topics. The study focuses on whether anxiety and depression improve six months after the coaching sessions. Participants will be randomly assigned to one of two groups. One group receives nine weekly telephone sessions with a peer coach who uses techniques from cognitive behavioral therapy (CBT), mindfulness, and exercise to address chronic pain and related issues. The other group receives nine telephone sessions with a coach who does not have RA and covers general health topics like nutrition and cancer awareness without using CBT or mindfulness. Sessions occur over 9 to 12 weeks, and data is collected multiple times during and after the intervention. Participants will complete surveys before starting, midway through, and at several timepoints after the sessions, including 3 weeks, 6 months, 12 months, and 24 months post-intervention. Researchers will measure changes in anxiety and depression using validated tools (PHQ-8 and GAD-7). Other assessments include pain interference, sleep disturbance, physical function, social isolation, stress, loneliness, and quality of life. The study monitors these outcomes to understand the impact of coaching on mental well-being in people with RA.
CONDITIONS
Brief Title
Healthier: Health Coaching for People With Rheumatoid Arthritis to Improve Mental Well-Being
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male or Female older than 18 years of age
- Diagnosed with Rheumatoid Arthritis by a rheumatologist and currently taking a Disease-Modifying Anti-rheumatic drug
- Have high levels of depression (PHQ-8 scores 10 to 20) or high levels of anxiety (GAD-7 scores above 10)
- Speaks English or Spanish
- Has access to the internet, a computer, and/or a smartphone
- Lives in any state of the US, including Puerto Rico
- Willing to work with a peer coach or a coach
You will not qualify if you...
- Has a rheumatic disease other than Rheumatoid Arthritis (e.g., psoriatic arthritis, gout, lupus)
- Is a nursing home resident
- Has a history of dementia or severe cognitive decline
- Is currently bedbound
- Has severe depression (PHQ-8 scores above 20)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (telephone or online)
Treatment
Duration - 9 to 12 weeks
Participants receive 9 telephone-delivered health coaching sessions over 9 to 12 weeks, either from a peer coach with rheumatoid arthritis or a coach with another chronic condition.
9 telephone sessions
Follow-up
Duration - Up to 24 months post-intervention
Participants are followed up for ongoing assessment of mental well-being and other outcomes for up to 24 months after completing the coaching intervention.
Assessments at 3 weeks, 6 months, 12 months, and 24 months post-intervention
Trial Site Locations
Total: 1 location
1
Weill Cornell Medical College
New York, New York, United States, 10065
Actively Recruiting
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Research Team
I
Iris Navarro-Millán, MD, MPH
S
Sarah Young, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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