title: Interactive Voice Response-Based Self-management for Chronic Back Pain: The COPES Noninferiority Randomized Trial.
abstract: Recommendations for chronic pain treatment emphasize multimodal approaches, including nonpharmacologic interventions to enhance self-management. Cognitive behavioral therapy (CBT) is an evidence-based treatment that facilitates management of chronic pain and improves outcomes, but access barriers persist. Cognitive behavioral therapy delivery assisted by health technology can obviate the need for in-person visits, but the effectiveness of this alternative to standard therapy is unknown. The Cooperative Pain Education and Self-management (COPES) trial was a randomized, noninferiority trial comparing IVR-CBT to in-person CBT for patients with chronic back pain.
  
  
  
  To assess the efficacy of interactive voice response-based CBT (IVR-CBT) relative to in-person CBT for chronic back pain.
  
  
  
  We conducted a noninferiority randomized trial in 1 Department of Veterans Affairs (VA) health care system. A total of 125 patients with chronic back pain were equally allocated to IVR-CBT (n = 62) or in-person CBT (n = 63).
  
  
  
  Patients treated with IVR-CBT received a self-help manual and weekly prerecorded therapist feedback based on their IVR-reported activity, coping skill practice, and pain outcomes. In-person CBT included weekly, individual CBT sessions with a therapist. Participants in both conditions received IVR monitoring of pain, sleep, activity levels, and pain coping skill practice during treatment.
  
  
  
  The primary outcome was change from baseline to 3 months in unblinded patient report of average pain intensity measured by the Numeric Rating Scale (NRS). Secondary outcomes included changes in pain-related interference, physical and emotional functioning, sleep quality, and quality of life at 3, 6, and 9 months. We also examined treatment retention.
  
  
  
  Of the 125 patients (97 men, 28 women; mean [SD] age, 57.9 [11.6] years), the adjusted average reduction in NRS with IVR-CBT (-0.77) was similar to in-person CBT (-0.84), with the 95% CI for the difference between groups (-0.67 to 0.80) falling below the prespecified noninferiority margin of 1 indicating IVR-CBT is noninferior. Fifty-four patients randomized to IVR-CBT and 50 randomized to in-person CBT were included in the analysis of the primary outcome. Statistically significant improvements in physical functioning, sleep quality, and physical quality of life at 3 months relative to baseline occurred in both treatments, with no advantage for either treatment. Treatment dropout was lower in IVR-CBT with patients completing on average 2.3 (95% CI, 1.0-3.6) more sessions.
  
  
  
  IVR-CBT is a low-burden alternative that can increase access to CBT for chronic pain and shows promise as a nonpharmacologic treatment option for chronic pain, with outcomes that are not inferior to in-person CBT.
  
  
  
  clinicaltrials.gov Identifier: NCT01025752.
authors.affiliation: VA Connecticut Healthcare System Pain Research, Informatics, Multimorbidities, and Education (PRIME) Health Services Research and Development Center of Innovation, West Haven2Yale School of Medicine, New Haven, Connecticut.
authors.forename: Alicia A
authors.initials: AA
authors.lastname: Heapy
authors.affiliation: VA Boston Healthcare System, Boston, Massachusetts4Boston University School of Medicine, Boston, Massachusetts.
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, West Haven2Yale School of Medicine, New Haven, Connecticut.
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, West Haven.
authors.forename: Kathryn M
authors.initials: KM
authors.lastname: LaChappelle
authors.affiliation: VA Connecticut Healthcare System Pain Research, Informatics, Multimorbidities, and Education (PRIME) Health Services Research and Development Center of Innovation, West Haven2Yale School of Medicine, New Haven, Connecticut.
authors.forename: Mary A
authors.initials: MA
authors.lastname: Driscoll
authors.affiliation: VA Connecticut Healthcare System Pain Research, Informatics, Multimorbidities, and Education (PRIME) Health Services Research and Development Center of Innovation, West Haven.
authors.forename: Rebecca A
authors.initials: RA
authors.lastname: Czlapinski
authors.affiliation: Yale School of Medicine, New Haven, Connecticut5Yale Center for Analytical Sciences, New Haven, Connecticut.
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, Michigan7University of Michigan School of Public Health, Ann Arbor8University of Michigan Medical School, Ann Arbor.
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, Michigan8University of Michigan Medical School, Ann Arbor.
authors.forename: Sarah L
authors.initials: SL
authors.lastname: Krein
authors.affiliation: VA Connecticut Healthcare System Pain Research, Informatics, Multimorbidities, and Education (PRIME) Health Services Research and Development Center of Innovation, West Haven2Yale School of Medicine, New Haven, Connecticut.
authors.forename: Robert D
authors.initials: RD
authors.lastname: Kerns
mesh_terms: D000368:Aged; D059350:Chronic Pain / Q000523:psychology / Q000628:therapy*; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D061345:Early Medical Intervention / Q000379:methods; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000523:psychology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D059408:Pain Management / Q000379:methods*; D010353:Patient Education as Topic / Q000379:methods; D012648:Self Care / Q000379:methods*; D000066908:Simulation Training / Q000379:methods*; D017216:Telemedicine / Q000379:methods