Interactive Voice Response–Based Self-management for Chronic Back Pain: The COPES Noninferiority Randomized Trial
Open accessAbstract
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.
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Previous persistent pain RCTs have used modified RMDQ as a primary outcome measure.
“Previous persistent pain RCTs28 46 have used modified RMDQ as a primary outcome measure.”
From Clinical and cost-effectiveness of an online-delivered group-based pain management programme in improving pain-related disability for people with persistent pain - Protocol for a non-inferiority randomised controlled trial (iSelf-help trial) (2021) · cites this paper as [28]
The paper’s Primary Outcome section identifies average pain intensity on an 11-point NRS as the primary outcome. Its Secondary Outcomes section lists the RMDQ as a measure of physical functioning, not as a primary outcome, and does not describe it as modified. The indexed copy does not provide page numbers for these sections. (LLM, conf=0.90)
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Experimental — accuracy not yet measuredHeapy et al reported no significant difference in pain-related disability, anxiety and depression outcomes.
“Similarly, Heapy et al 28 found that CBT-based, interactive voice response treatment was as effective as in-person delivered CBT in improving pain intensity after 3 months (SMD=0.07; 95% CI, 0.67 to 0.80; non-inferiority margin: −1); however, it reported no significant difference in pain-related disability, anxiety and depression outcomes.”
From Clinical and cost-effectiveness of an online-delivered group-based pain management programme in improving pain-related disability for people with persistent pain - Protocol for a non-inferiority randomised controlled trial (iSelf-help trial) (2021) · cites this paper as [28]
The Secondary Outcomes section (page unavailable) reports no significant between-group differences in any measured secondary outcome. The results table shows nonsignificant differences for disability (RMDQ) and depression (BDI-II), but our copy does not report a separate anxiety outcome, so that part of the claim is unsupported. (LLM, conf=0.87)
Experimental — accuracy not yet measuredHeapy et al found that CBT-based, interactive voice response treatment was as effective as in-person delivered CBT in improving pain intensity after 3 months.
“Similarly, Heapy et al 28 found that CBT-based, interactive voice response treatment was as effective as in-person delivered CBT in improving pain intensity after 3 months (SMD=0.07; 95% CI, 0.67 to 0.80; non-inferiority margin: −1); however, it reported no significant difference in pain-related disability, anxiety and depression outcomes.”
From Clinical and cost-effectiveness of an online-delivered group-based pain management programme in improving pain-related disability for people with persistent pain - Protocol for a non-inferiority randomised controlled trial (iSelf-help trial) (2021) · cites this paper as [28]
The Primary Outcome section reports that IVR-CBT was noninferior to in-person CBT for pain intensity at 3 months, supporting the main claim. The citing sentence misstates the accompanying statistics: the paper reports a mean difference of 0.07, not an SMD, a 95% CI of −0.67 to 0.80, and a noninferiority margin of 1. The Discussion reports no statistically significant between-group differences in secondary outcomes. (LLM, conf=0.90)
Experimental — accuracy not yet measured
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Telerehabilitation for Pain Management
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- Authors
- Heapy, A. A., Higgins, D. M., Goulet, J. L., LaChappelle, K. M., Driscoll, M. A., Czlapinski, R. A., Buta, E., Piette, J. D., Krein, S. L., & Kerns, R. D.
- Affiliations
- Yale University (US)
- Boston University (US)
- VA Connecticut Healthcare System (US)
- University of Michigan (US)
- Corresponding author
- Heapy, Alicia A.
- ORCID
- Venue
- JAMA Internal Medicine
- Publisher
- American Medical Association (AMA)
- Published
- 2017-06-01
- Volume
- 177
- Issue
- 6
- Pages
- 765
- ISSN
- 2168-6106 (ISSN-L)
- PMC
- PMC5818820
- OpenAlex
- W2604772958
- Cited by
- 101
- References
- 46
- Citations by year
- 2026: 7 · 2025: 12 · 2024: 13 · 2023: 13 · 2022: 16 · 2021: 13 · 2020: 7 · 2019: 12 · 2018: 5 · 2017: 3
- FWCI
- 5.16
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA Internal Medicine (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Health Services Research and Development (#CIN 13-407)
- National Institutes of Health (UL1TR001863)
- National Institute of Diabetes and Digestive and Kidney Diseases (P30DK092926)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Telemedicine and Telehealth Implementation
- Keywords
- chronic back pain, interactive voice response, cognitive behavioral therapy, telemedicine, self-management, non-inferiority, pain intensity, sleep quality, physical function, quality of life, veterans, treatment retention, access to mental health care, Veterans Affairs health care, non-pharmacological pain management
- MeSH terms
- Simulation Training, Aged, Female, Humans, Male, Middle Aged, Patient Education as Topic, Self Care, Cognitive Behavioral Therapy, Low Back Pain, Telemedicine, Chronic Pain, Pain Management, Early Medical Intervention
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