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Telehealth and online cognitive behavioral therapy-based treatments for high-impact chronic pain: a randomized clinical trial [with consumer summary]
DeBar LL, Mayhew M, Wellman RD, Balderson BH, Dickerson JF, Elder CR, Justice M, Keefe FJ, McMullen CK, Owen-Smith AA, Rini C, Von Korff M, Waring S, Yarava A, Shen Z, Thompson RE, Clark AE, Casper TC, Cook AJ
JAMA 2025 Jul 23;334(7):592-605
clinical trial
This trial has not yet been rated.

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 to 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 to 35.0) in the health coach group, 26.6 (95% CI 23.4 to 30.2) in the painTRAINER group, and 20.8 (95% CI 18.0 to 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 coachversus usual care: relative risk (RR) 1.54 (95% CI 1.30 to 1.82); painTRAINERversus usual care: RR 1.28 (95% CI 1.06 to 1.55)), and the health coach program was more effective than the online self-completed painTRAINER program (health coachversus painTRAINER: RR 1.20 (95% CI 1.03 to 1.40)). Statistically significant benefits were observed for both intervention groupsversus 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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