title: Cooperative pain education and self-management (COPES): study design and protocol of a randomized non-inferiority trial of an interactive voice response-based self-management intervention for chronic low back pain.
abstract: BACKGROUND
  The Institute of Medicine report "Relieving Pain in America" recommends the promotion of patient self-management of pain for all people with pain. Given the high prevalence of chronic pain in the US, new strategies are needed to enhance access to cognitive behavioral therapy (CBT) and other evidence-based treatments designed to facilitate self-management of chronic pain conditions. Although CBT is efficacious, many patients have limited or no access to CBT. Technology-assisted delivery of CBT may improve access while maintaining efficacy.
  
  
  METHODS
  We describe a randomized non-inferiority trial of interactive voice response (IVR)-based CBT for patients with chronic low back pain. This intervention uses daily IVR monitoring and weekly pre-recorded therapist feedback, based on patient-reported information, to provide treatment for patients at home. A total of 230 patients with chronic low back pain are being identified from a single statewide health system serving US military veterans. Participants are randomized to receive either ten weeks of in-person CBT or IVR-based CBT. The primary outcome is pain intensity as measured by the Numeric Rating Scale immediately post-treatment. Secondary outcomes include pain-related interference, emotional functioning, and quality of life measured immediately post treatment, and 6 and 9 months post recruitment. Exploratory objectives of the study are to examine: (1) potential mediators of impact on clinical outcomes (treatment retention, self-reported skill practice ratings, IVR call adherence, and treatment satisfaction); and (2) moderators of treatment engagement, adherence to therapist recommendations for pain coping skill practice, and effects on clinical outcomes.
  
  
  CONCLUSIONS
  This non-inferiority trial may identify an alternative to resource intensive in-person CBT that allows many more patients to receive care while also increasing retention of those enrolled in the program.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01025752 . Registered 3 December 2009.
authors.affiliation: VA Connecticut Healthcare System, Pain Research, Informatics, Multimorbidities, and Education (PRIME) Health Services Research and Development Center of Innovation, 11ACLGS, 950 Campbell Avenue, West Haven, CT, 06516, USA. alicia.heapy@va.gov.|Yale School of Medicine, New Haven, CT, USA. alicia.heapy@va.gov.
authors.forename: Alicia A
authors.initials: AA
authors.lastname: Heapy
authors.affiliation: VA Boston Healthcare System, Boston, MA, USA.|Boston University School of Medicine, Boston, MA, USA.
authors.forename: Diana M
authors.initials: DM
authors.lastname: Higgins
authors.affiliation: VA Connecticut Healthcare System, Pain Research, Informatics, Multimorbidities, and Education (PRIME) Health Services Research and Development Center of Innovation, 11ACLGS, 950 Campbell Avenue, West Haven, CT, 06516, USA.
authors.forename: Kathryn M
authors.initials: KM
authors.lastname: LaChappelle
authors.affiliation: Widener University, Chester, PA, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Kirlin
authors.affiliation: VA Connecticut Healthcare System, Pain Research, Informatics, Multimorbidities, and Education (PRIME) Health Services Research and Development Center of Innovation, 11ACLGS, 950 Campbell Avenue, West Haven, CT, 06516, USA.|Yale School of Medicine, New Haven, CT, USA.
authors.forename: Joseph L
authors.initials: JL
authors.lastname: Goulet
authors.affiliation: VA Connecticut Healthcare System, Pain Research, Informatics, Multimorbidities, and Education (PRIME) Health Services Research and Development Center of Innovation, 11ACLGS, 950 Campbell Avenue, West Haven, CT, 06516, USA.
authors.forename: Rebecca A
authors.initials: RA
authors.lastname: Czlapinski
authors.affiliation: Yale School of Medicine, New Haven, CT, USA.
authors.forename: Eugenia
authors.initials: E
authors.lastname: Buta
authors.affiliation: VA Ann Arbor Center for Clinical Management Research Health Services Research and Development Center of Innovation, Ann Arbor, MI, USA.|University of Michigan School of Public Health, Ann Arbor, MI, USA.|University of Michigan Medical School, Ann Arbor, MI, USA.
authors.forename: John D
authors.initials: JD
authors.lastname: Piette
authors.affiliation: VA Ann Arbor Center for Clinical Management Research Health Services Research and Development Center of Innovation, Ann Arbor, MI, USA.|University of Michigan Medical School, Ann Arbor, MI, USA.
authors.forename: Sarah L
authors.initials: SL
authors.lastname: Krein
authors.affiliation: University of Michigan Medical School, Ann Arbor, MI, USA.
authors.forename: Caroline R
authors.initials: CR
authors.lastname: Richardson
authors.affiliation: VA Connecticut Healthcare System, Pain Research, Informatics, Multimorbidities, and Education (PRIME) Health Services Research and Development Center of Innovation, 11ACLGS, 950 Campbell Avenue, West Haven, CT, 06516, USA.|Yale School of Medicine, New Haven, CT, USA.
authors.forename: Robert D
authors.initials: RD
authors.lastname: Kerns
mesh_terms: D006801:Humans; D059350:Chronic Pain / Q000523:psychology / Q000628:therapy; D015928:Cognitive Behavioral Therapy / Q000379:methods; D061345:Early Medical Intervention / Q000379:methods; D017116:Low Back Pain / Q000523:psychology / Q000628:therapy; D059408:Pain Management / Q000379:methods; D010147:Pain Measurement / Q000379:methods / Q000523:psychology; D010353:Patient Education as Topic / Q000379:methods; D012648:Self Care / Q000379:methods; D000066908:Simulation Training / Q000379:methods; D017216:Telemedicine; D014728:Veterans / Q000523:psychology; D000074099:Equivalence Trials as Topic