title: Pain coping skills training for African Americans with osteoarthritis (STAART): study protocol of a randomized controlled trial.
abstract: African Americans bear a disproportionate burden of osteoarthritis (OA), with higher prevalence rates, more severe pain, and more functional limitations. One key barrier to addressing these disparities has been limited engagement of African Americans in the development and evaluation of behavioral interventions for management of OA. Pain Coping Skills Training (CST) is a cognitive-behavioral intervention with shown efficacy to improve OA-related pain and other outcomes. Emerging data indicate pain CST may be a promising intervention for reducing racial disparities in OA symptom severity. However, there are important gaps in this research, including incorporation of stakeholder perspectives (e.g. cultural appropriateness, strategies for implementation into clinical practice) and testing pain CST specifically among African Americans with OA. This study will evaluate the effectiveness of a culturally enhanced pain CST program among African Americans with OA.
  
  
  
  This is a randomized controlled trial among 248 participants with symptomatic hip or knee OA, with equal allocation to a pain CST group and a wait list (WL) control group. The pain CST program incorporated feedback from patients and other stakeholders and involves 11 weekly telephone-based sessions. Outcomes are assessed at baseline, 12 weeks (primary time point), and 36 weeks (to assess maintenance of treatment effects). The primary outcome is the Western Ontario and McMaster Universities Osteoarthritis Index, and secondary outcomes include self-efficacy, pain coping, pain interference, quality of life, depressive symptoms, and global assessment of change. Linear mixed models will be used to compare the pain CST group to the WL control group and explore whether participant characteristics are associated with differential improvement in the pain CST program. This research is in compliance with the Helsinki Declaration and was approved by the Institutional Review Boards of the University of North Carolina at Chapel Hill, Durham Veterans Affairs Medical Center, East Carolina University, and Duke University Health System.
  
  
  
  This culturally enhanced pain CST program could have a substantial impact on outcomes for African Americans with OA and may be a key strategy in the reduction of racial health disparities.
  
  
  
  ClinicalTrials.gov, NCT02560922 , registered 9/22/2015.
authors.affiliation: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, 3300 Thurston Bldg., CB# 7280, Chapel Hill, NC, 27599, USA. leah_schrubbe@med.unc.edu.|Department of Medicine, University of North Carolina at Chapel Hill, 125 MacNider Hall CB# 7005, Chapel Hill, NC, 27599, USA. leah_schrubbe@med.unc.edu.
authors.forename: Leah A
authors.initials: LA
authors.lastname: Schrubbe
authors.affiliation: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, 3300 Thurston Bldg., CB# 7280, Chapel Hill, NC, 27599, USA.|Department of Medicine, University of North Carolina at Chapel Hill, 125 MacNider Hall CB# 7005, Chapel Hill, NC, 27599, USA.
authors.forename: Scott G
authors.initials: SG
authors.lastname: Ravyts
authors.affiliation: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, 3300 Thurston Bldg., CB# 7280, Chapel Hill, NC, 27599, USA.|Department of Medicine, University of North Carolina at Chapel Hill, 125 MacNider Hall CB# 7005, Chapel Hill, NC, 27599, USA.
authors.forename: Bernadette C
authors.initials: BC
authors.lastname: Benas
authors.affiliation: Department of Psychology, East Carolina University, Greenville, NC, USA.
authors.forename: Lisa C
authors.initials: LC
authors.lastname: Campbell
authors.affiliation: Department of Medicine, University of North Carolina at Chapel Hill, 125 MacNider Hall CB# 7005, Chapel Hill, NC, 27599, USA.
authors.forename: Crystal W
authors.initials: CW
authors.lastname: Cené
authors.affiliation: Health Services Research and Development Service, Durham VA Medical Center, Durham, NC, USA.|Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.
authors.forename: Cynthia J
authors.initials: CJ
authors.lastname: Coffman
authors.affiliation: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, 3300 Thurston Bldg., CB# 7280, Chapel Hill, NC, 27599, USA.|Department of Medicine, University of North Carolina at Chapel Hill, 125 MacNider Hall CB# 7005, Chapel Hill, NC, 27599, USA.
authors.forename: Alexander H
authors.initials: AH
authors.lastname: Gunn
authors.affiliation: Department of Psychiatry and Behavioral Science, Duke University, Durham, NC, USA.
authors.forename: Francis J
authors.initials: FJ
authors.lastname: Keefe
authors.affiliation: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, 3300 Thurston Bldg., CB# 7280, Chapel Hill, NC, 27599, USA.|Department of Medicine, University of North Carolina at Chapel Hill, 125 MacNider Hall CB# 7005, Chapel Hill, NC, 27599, USA.
authors.forename: Caroline T
authors.initials: CT
authors.lastname: Nagle
authors.affiliation: Health Services Research and Development Service, Durham VA Medical Center, Durham, NC, USA.|Department of Medicine, Duke University Medical Center, Durham, NC, USA.
authors.forename: Eugene Z
authors.initials: EZ
authors.lastname: Oddone
authors.affiliation: Department of Psychiatry and Behavioral Science, Duke University, Durham, NC, USA.
authors.forename: Tamara J
authors.initials: TJ
authors.lastname: Somers
authors.affiliation: Health Services Research and Development Service, Durham VA Medical Center, Durham, NC, USA.|Department of Medicine, Duke University Medical Center, Durham, NC, USA.
authors.forename: Catherine L
authors.initials: CL
authors.lastname: Stanwyck
authors.affiliation: Health Services Research and Development Service, Durham VA Medical Center, Durham, NC, USA.
authors.forename: Shannon S
authors.initials: SS
authors.lastname: Taylor
authors.affiliation: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, 3300 Thurston Bldg., CB# 7280, Chapel Hill, NC, 27599, USA.|Department of Medicine, University of North Carolina at Chapel Hill, 125 MacNider Hall CB# 7005, Chapel Hill, NC, 27599, USA.|Health Services Research and Development Service, Durham VA Medical Center, Durham, NC, USA.
authors.forename: Kelli D
authors.initials: KD
authors.lastname: Allen
mesh_terms: D000223:Adaptation, Psychological; D001741:Black or African American; D003376:Counseling / Q000379:methods*; D065246:Culturally Competent Care / Q000379:methods*; D003863:Depression / Q000453:epidemiology / Q000209:etiology; D000071219:Global Burden of Disease; D054624:Health Status Disparities; D006801:Humans; D015207:Osteoarthritis, Hip / Q000453:epidemiology / Q000523:psychology / Q000628:therapy*; D020370:Osteoarthritis, Knee / Q000453:epidemiology / Q000523:psychology / Q000628:therapy*; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement; D015995:Prevalence; D011788:Quality of Life; D020377:Self Efficacy; D013689:Telephone; D016896:Treatment Outcome
keywords: Health disparities; Hip; Knee; Osteoarthritis; Pain coping skills training