Self-Directed vs Clinician-Delivered Cognitive Behavioral Therapy for Chronic Pain

Importance: Cognitive behavioral therapy for chronic pain (CBT-CP) is a first-line nonpharmacological treatment, but uptake remains low due to multiple access barriers. Objective: To assess the effectiveness of self-directed CBT-CP with asynchronous, personalized feedback relative to clinician-delivered CBT-CP under usual clinical practice conditions. Design, Setting, and Participants: This randomized, open-label pragmatic superiority trial enrolled 764 patients with chronic musculoskeletal pain from 9 US Veterans Health Administration (VHA) health care systems from December 20, 2019, to February 20, 2024; follow-up was completed in February 2025. Interventions: Participants were allocated 1:1 to self-directed CBT-CP (n = 384) or clinician-delivered CBT-CP (n = 380). The self-directed group included 11 weeks of treatment with weekly personalized audio-recorded feedback provided by coaches. Feedback was based on participants' daily reports of pain coping skill practice, physical activity, and pain-relevant ratings collected by the interactive voice response system. Clinician-delivered CBT-CP included 4 to 11 weekly sessions provided under usual practice conditions. Main Outcomes and Measures: The primary outcome was patient-reported pain interference measured by the 7-item Brief Pain Inventory-Interference (BPI-I) subscale at 4 months (score range, 0-10; higher scores indicate worse function; minimum clinically important difference, 1). Secondary outcomes included BPI-I at 6 and 12 months; pain intensity, pain impact, catastrophizing, self-efficacy, sleep, global impression of change, depressive symptoms (all at 4 months); and treatment dose. Results: Of the 764 randomized participants (mean age, 52.8 [SD, 12.3] years; 299 women [39.1%]; 289 Black [39.1%]; 399 White [54.0%]; and 107 Hispanic ethnicity [14.0%] and 186 participants [24%] who resided in a rural area), 583 participants (76%) completed the 4-month assessment and 523 (68%) the 12-month assessment. At 4 months, the self-directed CBT-CP was superior to clinician-delivered CBT-CP for reduction in pain interference (mean score, 5.26 vs 6.23, respectively; mean difference, -0.98; 95% CI, -1.31 to -0.65, P < .001) and maintained superiority at 6 and 12 months. Self-directed CBT-CP was superior to clinician-delivered CBT-CP for all other outcomes at 4 months (P ≤ .001). Participants in the self-directed CBT-CP group completed more expected treatment sessions than patients in the clinician-delivered CBT-CP group. Conclusions and Relevance: Self-directed CBT-CP was associated with modest improvements in pain interference at 4 months that were sustained to 12 months, small to moderate improvements in all secondary outcomes at 4 months, and higher session-completion rates, relative to clinician-delivered CBT-CP. Scalable, convenient self-directed CBT may be an effective alternative to clinician-delivered CBT that could increase uptake of CBT-CP. Trial Registration: ClinicalTrials.gov Identifier: NCT03469505.