Efficacy of a Single-Session "Empowered Relief" Zoom-Delivered Group Intervention for Chronic Pain: Randomized Controlled Trial Conducted During COVID-19 (Preprint)

BACKGROUND Pain-cognitive behavioral therapy is an evidence-based treatment for chronic pain, with significant patient burden including healthcare cost, travel, multiple sessions, and lack of access in remote areas. A previously developed and efficacious single-session intervention “Empowered Relief” (ER) based on CBT principles has particular salience and fills an urgent clinical need during COVID-19. However, key questions remain about the efficacy of online-delivered ER. OBJECTIVE The primary goal is to pilot test the comparative efficacy of a single-session videoconference-delivered ER group to a waitlist control (WLC) among individuals with chronic pain. We hypothesized that ER would be superior to WLC for reductions in pain catastrophizing, pain intensity, and other pain-related outcomes at 1-3 months post-treatment. METHODS We conducted a randomized controlled trial involving an online sample of adults (N=104) aged 18-80 years with self-reported chronic pain. Participants were randomized (1:1) to one of the two unblinded study groups: ER (n=50) or a WLC (n=54). Participants allocated to ER completed a Zoom-delivered class, and all participants completed follow-up surveys at 2 weeks, 1, 2, and 3 months post-treatment. All study procedures occurred remotely and electronically. The primary outcome was pain catastrophizing one-month post-treatment, with pain intensity, pain bothersomeness, and sleep disruption as secondary outcomes. We also report a more rigorous test of the durability of treatment effects at 3 months post-treatment. Data were collected from September 2020 - February 2021 and analyzed using intention-to-treat analysis. The analytic dataset included participants (18% clinic patients, 82% community) who completed at least one study surveys: ER (n=50) and WLC (n=51). RESULTS Participants (N=101) were 69.3% (70/101) female, with mean age of 49.76 years (SD 13.90; range 24.00-78.00); 32.7% (33/101) had an undergraduate degree, with self-reported chronic pain >= 3 months. Participants reported high engagement (94%), high satisfaction with ER (mean 8.26, SD 1.57; range 0-10), and Zoom-platform (92%). For the between-groups factor, ER was superior to WLC for all primary and secondary outcomes at 3 -months post-treatment (highest P=.0001), and between-groups Cohen d effect sizes ranged from 0.45 to 0.79, indicating superiority was of moderate to substantial clinical importance. At 3 months, clinically meaningful PCS reductions were found for ER but not for WLC (ER: PCS, -8.72, 42.25% reduction; WLC: PCS -2.25, 11.13% reduction). ER resulted in significant improvements in pain intensity, sleep disturbance, and clinical improvements in pain bothersomeness. CONCLUSIONS Zoom-delivered ER had high participant satisfaction and very high engagement. Among adults with chronic pain, this single-session, Zoom-delivered, skills-based pain class resulted in clinically significant improvement across a range of pain-related outcomes and sustained at 3 months. Online delivery of ER could allow greater accessibility of home-based pain treatment and could address the inconveniences and barriers faced by patients when attempting to receive in-person care. CLINICALTRIAL ClinicalTrials.gov Identifier NCT 04546685, Registered on 04 September 2020.