Background Cognitive behavioral therapy–pain is an evidence-based treatment for chronic pain that can have significant patient burden, including health care cost, travel, multiple sessions, and lack of access in remote areas. Objective The study aims to pilot test the efficacy of a single-session videoconference-delivered empowered relief (ER) intervention compared to waitlist control (WLC) conditions among individuals with chronic pain. We hypothesized that ER would be superior to WLC in reducing pain catastrophizing, pain intensity, and other pain-related outcomes at 1-3 months posttreatment. Methods We conducted a randomized controlled trial involving a web-based sample of adults (N=104) aged 18-80 years with self-reported chronic pain. Participants were randomized (1:1) to 1 of 2 unblinded study groups: ER (50/104, 48.1%) and WLC (54/104, 51.9%). Participants allocated to ER completed a Zoom-delivered class, and all participants completed follow-up surveys at 2 weeks and 1, 2, and 3 months posttreatment. All the study procedures were performed remotely and electronically. The primary outcome was pain catastrophizing 1-month posttreatment, 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 posttreatment. Data were collected from September 2020 to February 2021 and analyzed using intention-to-treat analysis. The analytic data set included participants (18/101, 17.8% clinic patients; 83/101, 82.1% community) who completed at least one study survey: ER (50/101, 49.5%) and WLC (51/104, 49%). Results Participants (N=101) were 69.3% (70/101) female, with a mean age of 49.76 years (SD 13.90; range 24-78); 32.7% (33/101) had an undergraduate degree and self-reported chronic pain for 3 months. Participants reported high engagement (47/50, 94%), high satisfaction with ER (mean 8.26, SD 1.57; range 0-10), and high satisfaction with the Zoom platform (46/50, 92%). For the between-groups factor, ER was superior to WLC for all primary and secondary outcomes at 3 months posttreatment (highest P<.001), and between-groups Cohen d effect sizes ranged from 0.45 to 0.79, indicating that the superiority was of moderate to substantial clinical importance. At 3 months, clinically meaningful pain catastrophizing scale (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 that was sustained at 3 months. Web-based 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. Trial Registration ClinicalTrials.gov NCT04546685; https://clinicaltrials.gov/ct2/show/NCT04546685
Background Chronic pain is naturally aversive and often distressing for patients. Pain coping and self-regulatory skills have been shown to effectively reduce pain-related distress and other symptoms. In this trial, the primary goal is to pilot test the comparative efficacy of a single-session videoconference-delivered group pain education class to a waitlist control among patients with chronic pain. Methods Our study is a randomized clinical trial pilot testing the superiority of our 2-h single-session videoconference-delivered group pain education class against a waitlist control. We will enroll 120 adult patients with mixed etiology chronic pain and randomize 1:1 to one of the two study arms. We hypothesize superiority for the pain education class for bolstering pain and symptom management. Team researchers masked to treatment assignment will assess the outcomes up to 3 months post-treatment. Discussion This study aims to test the utility of a single-session videoconference-delivered group pain education class to improve self-regulation of pain and pain-related outcomes. Findings from our project have the potential to significantly reduce barriers to effective psychological treatment for pain, optimizing the delivery of increasingly vital online and remote-delivered intervention options. Trial registration ClinicalTrials.govNCT04546685. Registered on 04 September 2020.
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.
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