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. 2025 Jul 23;334(7):592-605.
doi: 10.1001/jama.2025.11178. Online ahead of print.

Telehealth and Online Cognitive Behavioral Therapy-Based Treatments for High-Impact Chronic Pain: A Randomized Clinical Trial

Lynn L DeBar  1 , Meghan Mayhew  1 , Robert D Wellman  2 , Benjamin H Balderson  2 , John F Dickerson  1 , Charles R Elder  1 , Morgan Justice  2 , Francis J Keefe  3 , Carmit K McMullen  1 , Ashli A Owen-Smith  4 , Christine Rini  5 , Michael Von Korff  2 , Stephen Waring  6 , Anusha Yarava  7 , Ziling Shen  8 , Richard E Thompson  8 , Amy E Clark  9 , T Charles Casper  10 , Andrea J Cook  2
Affiliations

Telehealth and Online Cognitive Behavioral Therapy-Based Treatments for High-Impact Chronic Pain: A Randomized Clinical Trial

Lynn L DeBar et al. JAMA. .

Abstract

Importance: Cognitive behavioral therapy (CBT) skills training interventions are recommended first-line nonpharmacologic treatment for chronic pain, yet they are not widely accessible.

Objective: To examine effectiveness of remote, scalable CBT-based chronic pain (CBT-CP) treatments (telehealth and self-completed online) for individuals with high-impact chronic pain, compared with usual care.

Design, setting, and participants: This comparative effectiveness, 3-group, phase 3 randomized clinical trial enrolled 2331 eligible patients with high-impact chronic musculoskeletal pain from 4 geographically diverse health care systems in the US from January 2021 through February 2023. Follow-up concluded in April 2024.

Interventions: Participants were randomized 1:1:1 to 1 of 2 remote, 8-session, CBT-based skills training treatments: health coach-led via telephone/videoconferencing (health coach; n = 778) or online self-completed program (painTRAINER; n = 776); or to usual care plus a resource guide (n = 777).

Main outcomes and measures: The primary outcome was attaining or exceeding the minimal clinically important difference (MCID) in pain severity score (≥30% decrease; score range, 0-10) on the 11-item Brief Pain Inventory-Short Form from baseline to 3 months; 6 and 12 months from baseline were secondary time points. Secondary outcomes at 3, 6, and 12 months included pain intensity, pain-related interference, PROMIS (Patient-Reported Outcomes Measurement Information System) social role and physical functioning; and patient global impression of change.

Results: Among 2331 eligible randomized individuals (mean age, 58.8 [SD, 14.3] years; 1712 [74%] women; 1030 [44%] rural/medically underserved), 2210 (94.8%) completed the trial. At 3 months, the adjusted percentage of participants achieving 30% or greater decrease in pain severity score was 32.0 (95% CI, 29.3-35.0) in the health coach group, 26.6 (95% CI, 23.4-30.2) in the painTRAINER group, and 20.8 (95% CI, 18.0-24.0) in the usual care group. Both intervention groups were significantly more likely to attain an MCID in pain severity compared with control (health coach vs usual care: relative risk [RR], 1.54 [95% CI, 1.30-1.82]; painTRAINER vs usual care: RR, 1.28 [95% CI, 1.06-1.55]), and the health coach program was more effective than the online self-completed painTRAINER program (health coach vs painTRAINER: RR, 1.20 [95% CI, 1.03-1.40]). Statistically significant benefits were observed for both intervention groups vs usual care at 6 and 12 months after randomization for the pain severity outcomes and for other secondary pain and functioning outcomes.

Conclusions and relevance: Remote, scalable CBT-CP treatments (delivered either via telehealth or self-completed modules online) resulted in modest improvements in pain and related functional/quality-of-life outcomes compared with usual care among individuals with high-impact chronic pain. These lower-resource CBT-CP treatments could improve availability of evidence-based nonpharmacologic pain treatments within health care systems.

Trial registration: ClinicalTrials.gov Identifier: NCT04523714.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Keefe reported receiving grants from Duke University during the conduct of the study; in addition, Duke University, on behalf of Dr Keefe, holds the copyright to painTRAINER. This online program is free to all who wish to use it; neither Duke University nor Dr Keefe receives any funds for the use of this online program. Dr Cook reported receiving grants from the Centers for Disease Control and Prevention and the Patient-Centered Outcomes Research Institute outside the submitted work. No other disclosures were reported.

References

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