Interactive Voice Response-Based Self-management for Chronic Back Pain: The COPES Noninferiority Randomized Trial

Abstract

Importance: 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.

Objective: To assess the efficacy of interactive voice response-based CBT (IVR-CBT) relative to in-person CBT for chronic back pain.

Design, setting, and participants: 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).

Interventions: 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.

Main outcomes and measures: 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.

Results: 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.

Conclusions and relevance: 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.

Trial registration: clinicaltrials.gov Identifier: NCT01025752.

Figure 1.. Participant Flow Through Trial Comparing IVR-CBT With In-Person CBT for Back Pain

^aPatients who had at least 1 postbaseline assessment. BDI-II indicates Beck Depression Inventory II; CBT, cognitive behavioral therapy; IVR, interactive voice response; MINI, Mini International Neuropsychiatric Interview Version 6.0.0; SLUMS, Saint Louis University Mental Status examination.

Figure 2.. Number of Treatment Weeks by Condition

CBT indicates cognitive behavioral therapy; IVR, interactive voice response.

Figure 3.. Possible Scenarios and Observed Results of the Noninferiority Test

Error bars represent 2-sided 95% CIs. A CI that lies entirely to the left of zero indicates the new treatment (CBT, cognitive behavioral therapy; IVR, interactive voice response [IVR-CBT]) is superior. A CI that lies to the left of the noninferiority margin of 1 indicates that the new treatment is noninferior. A CI that includes the noninferiority margin indicates that the result regarding noninferiority is inconclusive. A CI that is entirely above the noninferiority margin indicates the new treatment is inferior. Figure and explanation adapted from Piaggio et al.