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

Official title

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

Overview

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

• Behavioral Peer Coach
  The method that will be used in this trial will be peer coaching. Peer coaches are lay individuals who themselves have the targeted chronic condition, that for the purpose of this study is people with RA, allowing people to identify with their peers and increase confidence that they too can achieve favorable outcomes. They will use components of CBT, mindfulness, and exercise material that have been effective in improving mental and physical health in patients with RA. The Healthier intervention
• Behavioral Healthy Horizons
  Participants in the active comparator arm will have telephone calls with a coach that does not have rheumatoid arthritis and who will deliver a nine-session intervention on general health topics that are widely available including topics on nutrition and cancer awareness. These coaches will not use CBT, mindfulness or make any references to exercise or physical activity.

Primary outcome measures

• Change from Baseline in Mean Scores in PHQ-8 at 6 months post intervention [Time frame: Baseline and 6 months after completing the intervention (35 weeks after baseline)]
• Difference in Mean Scores in PHQ-8 Between the Experimental Arm and the Active Control Arm at 6 Months Post Intervention [Time frame: Six months post intervention completion (Approximately 35 weeks after baseline)]
• Change from Baseline in Mean Scores in GAD-7 at 6 months post intervention [Time frame: 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 [Time frame: Six months post intervention completion (35 weeks after baseline)]

Secondary outcome measures (12)

• Change from Baseline in Mean Scores in PROMIS Pain Interference Midway Through the Intervention [Time frame: Baseline, Midway through the intervention (4 weeks after baseline)]
• Change from Baseline in Mean Scores in PROMIS Pain Interference at 3 Weeks Post-Intervention [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Baseline, 24 Months Post-Intervention Completion (113 weeks after baseline)]
• Change from Baseline in Mean Scores in PROMIS Sleep Disturbance Midway Through the Intervention [Time frame: Baseline, Midway through the intervention (4 weeks after baseline)]
• Change from Baseline in Mean Scores in PROMIS Sleep Disturbance at 3 Weeks Post-Intervention [Time frame: Baseline, 3 Weeks Post-Intervention (12 weeks after baseline)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• Weill Cornell Medical College — New York

Publications

• Little RJ, Wang Y. Pattern-mixture models for multivariate incomplete data with covariates. Biometrics. 1996 Mar;52(1):98-111. PMID 8934587
• Royston P, White IR. Multiple imputation by chained equations (MICE): implementation in Stata. Journal of statistical software. 2011;45:1-20
• McCurry SM, Von Korff M, Vitiello MV, Saunders K, Balderson BH, Moore AL, Rybarczyk BD. Frequency of comorbid insomnia, pain, and depression in older adults with osteoarthritis: predictors of enrollment in a randomized treatment trial. J Psychosom Res. 2011 Nov;71(5):296-9. doi: 10.1016/j.jpsychores.2011.05.012. Epub 2011 Jul 1. PMID 21999972
• Vasiliadis HM, Chudzinski V, Gontijo-Guerra S, Preville M. Screening instruments for a population of older adults: The 10-item Kessler Psychological Distress Scale (K10) and the 7-item Generalized Anxiety Disorder Scale (GAD-7). Psychiatry Res. 2015 Jul 30;228(1):89-94. doi: 10.1016/j.psychres.2015.04.019. Epub 2015 Apr 23. PMID 25956759
• Osman A, Barrios FX, Kopper BA, Hauptmann W, Jones J, O'Neill E. Factor structure, reliability, and validity of the Pain Catastrophizing Scale. J Behav Med. 1997 Dec;20(6):589-605. doi: 10.1023/a:1025570508954. PMID 9429990
• Toussaint A, Husing P, Gumz A, Wingenfeld K, Harter M, Schramm E, Lowe B. Sensitivity to change and minimal clinically important difference of the 7-item Generalized Anxiety Disorder Questionnaire (GAD-7). J Affect Disord. 2020 Mar 15;265:395-401. doi: 10.1016/j.jad.2020.01.032. Epub 2020 Jan 15. PMID 32090765
• Kounali D, Button KS, Lewis G, Gilbody S, Kessler D, Araya R, Duffy L, Lanham P, Peters TJ, Wiles N, Lewis G. How much change is enough? Evidence from a longitudinal study on depression in UK primary care. Psychol Med. 2022 Jul;52(10):1875-1882. doi: 10.1017/S0033291720003700. Epub 2020 Nov 3. PMID 33138872
• Bauer-Staeb C, Kounali DZ, Welton NJ, Griffith E, Wiles NJ, Lewis G, Faraway JJ, Button KS. Effective dose 50 method as the minimal clinically important difference: Evidence from depression trials. J Clin Epidemiol. 2021 Sep;137:200-208. doi: 10.1016/j.jclinepi.2021.04.002. Epub 2021 Apr 20. PMID 33892086

Identifiers

NCT: NCT07222696 · 25-05028875

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗