Empowered Relief, cognitive behavioral therapy, and health education for people with chronic pain: a comparison of outcomes at 6-month Follow-up for a randomized controlled trial

Supplemental Digital Content is Available in the Text.A One-session empowered relief provides clinically meaningful effects comparable to an 8-session cognitive behavioral therapy at 6 months for chronic low back pain. Effectiveness data are needed in diverse patients. Introduction:We previously conducted a 3-arm randomized trial (263 adults with chronic low back pain) which compared group-based (1) single-session pain relief skills intervention (Empowered Relief; ER); (2) 8-session cognitive behavioral therapy (CBT) for chronic back pain; and (3) single-session health and back pain education class (HE). Results suggested non-inferiority of ER vs. CBT at 3 months post-treatment on an array of outcomes.Here, we tested the durability of treatment effects at 6 months post-treatment. We examined group differences in primary and secondary outcomes at 6 months and the degree to which outcomes eroded or improved from 3-month to 6-month within each treatment group.Empowered Relief remained non-inferior to CBT on most outcomes, whereas both ER and CBT remained superior to HE on most outcomes. Outcome improvements within ER did not decrease significantly from 3-month to 6-month, and indeed ER showed additional 3- to 6-month improvements on pain catastrophizing, pain bothersomeness, and anxiety. Effects of ER at 6 months post-treatment (moderate term outcomes) kept pace with effects reported by participants who underwent 8-session CBT.The maintenance of these absolute levels implies strong stability of ER effects. Results extend to 6 months post-treatment previous findings documenting that ER and CBT exhibit similarly potent effects on outcomes.Chronic low back pain is the most prevalent chronic pain condition among adults worldwide.18 Patient education on pain self-management and multisession cognitive behavioral therapy (CBT) are recommended as first-line treatments for back pain,17 and the National Institute for Health and Care Excellence (NICE) guidelines recommend CBT integration into comprehensive care plans.27 Often, group-based CBT for chronic pain is delivered over eight 2-hour sessions (16 hours total treatment time). Content includes pain education, self-regulatory skills training, problem-solving and action planning, and home practice between sessions. Rigorous back pain studies8,38 and chronic pain meta-analyses41 suggest CBT has small-to-moderate effects for multidimensional symptom reduction in chronic pain. However, multiple barriers prevent broad access to CBT, such as physician referral, lack of insurance in the U.S., lack of trained professionals, extensive wait times, and burdens associated with multisession treatment.11,25 Effective briefer options could ease care barriers, facilitate the implementation of recommended guidelines, and scale best practices to treat chronic low back pain.Empowered Relief (ER) is a 2-hour single-session pain relief skills intervention that includes cognitive behavioral skills acquisition, mindfulness principles, and pain neuroscience education.10,12,13 Previously, we conducted a three-arm randomized controlled trial in 263 community adults with chronic low back pain in which we compared 2-hour ER, a 2-hour back health education (HE) class, and an 8-session back pain CBT protocol (16 hours of total treatment time).7,8 In this trial, pain catastrophizing, a cognitive and emotional pain response pattern that includes increased attention, and feelings of pain helplessness, was selected as the primary outcome because of its impacts on the intensity and trajectory of chronic pain6,39 and responsiveness to CBT.38,40,41 Results revealed noninferiority in outcome potency of a 2-hour pain relief skills intervention compared with a standard course of an 8-session CBT at 3 months posttreatment. Specifically, ER was noninferior to an 8-session CBT for reducing pain catastrophizing, pain intensity, pain interference, pain bothersomeness, fatigue, sleep disturbance, anxiety, and depression; across variables, ER and CBT had moderate-to-large treatment effects that were superior to HE at 3 months.13 Such findings suggest that for some patients, brief psychosocial pain interventions may represent satisfactory alternatives to more lengthy and resource-intensive treatment, at least in the short-term. Evidence of extended efficacy of 1-session ER could inform broad treatment adoption in clinical practice, resource allocation, and third-party payer reimbursement in the U.S.Accordingly, the current report describes 6-month outcome data for our three-arm randomized comparative efficacy trial. First, we examined whether ER retained noninferiority to CBT and superiority to HE on baseline to 6-month posttreatment changes for primary and secondary outcomes. Results of these analyses also would indicate the relative position of an 8-session CBT and brief ER with respect to maintenance of longer-term effects. We hypothesized that at 6 months posttreatment, ER and CBT would be superior to HE and that ER would maintain noninferiority with CBT. Second, we examined the degree to which ER showed increments or decrements in outcome values from 3 months to 6 months posttreatment. Results of these analyses would indicate the degree to which effects of brief ER changed or maintained their absolute position from 3 months to 6 months posttreatment.We conducted this three-arm randomized comparative efficacy trial at a single academic site in the San Francisco Bay Area after trial preregistration4 and the published protocol.12 The trial tested for noninferiority in comparing a 1-session ER vs an 8-session CBT and superiority in comparing a 1-session ER vs a 1-session HE and an 8-session CBT vs a 1-session HE. The study protocol followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines on noninferiority trials (Fig. 1),31 was approved by Stanford's institutional review board, included a data and safety monitoring board, and the trial was overseen by an independent monitoring agency appointed by the National Institutes of Health.CONSORT diagram to 6 months posttreatment. CBT, cognitive behavioral therapy; ER, Empowered Relief; HE, health education.Introduction:We previously conducted a 3-arm randomized trial (263 adults with chronic low back pain) which compared group-based (1) single-session pain relief skills intervention (Empowered Relief; ER); (2) 8-session cognitive behavioral therapy (CBT) for chronic back pain; and (3) single-session health and back pain education class (HE). Results suggested non-inferiority of ER vs. CBT at 3 months post-treatment on an array of outcomes.Here, we tested the durability of treatment effects at 6 months post-treatment. We examined group differences in primary and secondary outcomes at 6 months and the degree to which outcomes eroded or improved from 3-month to 6-month within each treatment group.Empowered Relief remained non-inferior to CBT on most outcomes, whereas both ER and CBT remained superior to HE on most outcomes. Outcome improvements within ER did not decrease significantly from 3-month to 6-month, and indeed ER showed additional 3- to 6-month improvements on pain catastrophizing, pain bothersomeness, and anxiety. Effects of ER at 6 months post-treatment (moderate term outcomes) kept pace with effects reported by participants who underwent 8-session CBT. The maintenance of these absolute levels implies strong stability of ER effects. Results extend to 6 months post-treatment previous findings documenting that ER and CBT exhibit similarly potent effects on outcomes.Chronic low back pain is the most prevalent chronic pain condition among adults worldwide.18 Patient education on pain self-management and multisession cognitive behavioral therapy (CBT) are recommended as first-line treatments for back pain,17 and the National Institute for Health and Care Excellence (NICE) guidelines recommend CBT integration into comprehensive care plans.27 Often, group-based CBT for chronic pain is delivered over eight 2-hour sessions (16 hours total treatment time). Content includes pain education, self-regulatory skills training, problem-solving and action planning, and home practice between sessions. Rigorous back pain studies8,38 and chronic pain meta-analyses41 suggest CBT has small-to-moderate effects for multidimensional symptom reduction in chronic pain. However, multiple barriers prevent broad access to CBT, such as physician referral, lack of insurance in the U.S., lack of trained professionals, extensive wait times, and burdens associated with multisession treatment.11,25 Effective briefer options could ease care barriers, facilitate the implementation of recommended guidelines, and scale best practices to treat chronic low back pain.Empowered Relief (ER) is a 2-hour single-session pain relief skills intervention that includes cognitive behavioral skills acquisition, mindfulness principles, and pain neuroscience education.10,12,13 Previously, we conducted a three-arm randomized controlled trial in 263 community adults with chronic low back pain in which we compared 2-hour ER, a 2-hour back health education (HE) class, and an 8-session back pain CBT protocol (16 hours of total treatment time).7,8 In this trial, pain catastrophizing, a cognitive and emotional pain response pattern that includes increased attention, and feelings of pain helplessness, was selected as the primary outcome because of its impacts on the intensity and trajectory of chronic pain6,39 and responsiveness to CBT.38,40,41 Results revealed noninferiority in outcome potency of a 2-hour pain relief skills intervention compared with a standard course of an 8-session CBT at 3 months posttreatment. Specifically, ER was noninferior to an 8-session CBT for reducing pain catastrophizing, pain intensity, pain interference, pain bothersomeness, fatigue, sleep disturbance, anxiety, and depression; across variables, ER and CBT had moderate-to-large treatment effects that were superior to HE at 3 months.13 Such findings suggest that for some patients, brief psychosocial pain interventions may represent satisfactory alternatives to more lengthy and resource-intensive treatment, at least in the short-term. Evidence of extended efficacy of 1-session ER could inform broad treatment adoption in clinical practice, resource allocation, and third-party payer reimbursement in the U.S.Accordingly, the current report describes 6-month outcome data for our three-arm randomized comparative efficacy trial. First, we examined whether ER retained noninferiority to CBT and superiority to HE on baseline to 6-month posttreatment changes for primary and secondary outcomes. Results of these analyses also would indicate the relative position of an 8-session CBT and brief ER with respect to maintenance of longer-term effects. We hypothesized that at 6 months posttreatment, ER and CBT would be superior to HE and that ER would maintain noninferiority with CBT. Second, we examined the degree to which ER showed increments or decrements in outcome values from 3 months to 6 months posttreatment. Results of these analyses would indicate the degree to which effects of brief ER changed or maintained their absolute position from 3 months to 6 months posttreatment.We conducted this three-arm randomized comparative efficacy trial at a single academic site in the San Francisco Bay Area after trial preregistration4 and the published protocol.12 The trial tested for noninferiority in comparing a 1-session ER vs an 8-session CBT and superiority in comparing a 1-session ER vs a 1-session HE and an 8-session CBT vs a 1-session HE. The study protocol followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines on noninferiority trials (Fig. 1),31 was approved by Stanford's institutional review board, included a data and safety monitoring board, and the trial was overseen by an independent monitoring agency appointed by the National Institutes of Health.CONSORT diagram to 6 months posttreatment. CBT, cognitive behavioral therapy; ER, Empowered Relief; HE, health education.Introduction:We previously conducted a 3-arm randomized trial (263 adults with chronic low back pain) which compared group-based (1) single-session pain relief skills intervention (Empowered Relief; ER); (2) 8-session cognitive behavioral therapy (CBT) for chronic back pain; and (3) single-session health and back pain education class (HE). Results suggested non-inferiority of ER vs. CBT at 3 months post-treatment on an array of outcomes.Here, we tested the durability of treatment effects at 6 months post-treatment. We examined group differences in primary and secondary outcomes at 6 months and the degree to which outcomes eroded or improved from 3-month to 6-month within each treatment group.Empowered Relief remained non-inferior to CBT on most outcomes, whereas both ER and CBT remained superior to HE on most outcomes. Outcome improvements within ER did not decrease significantly from 3-month to 6-month, and indeed ER showed additional 3- to 6-month improvements on pain catastrophizing, pain bothersomeness, and anxiety. Effects of ER at 6 months post-treatment (moderate term outcomes) kept pace with effects reported by participants who underwent 8-session CBT.The maintenance of these absolute levels implies strong stability of ER effects. Results extend to 6 months post-treatment previous findings documenting that ER and CBT exhibit similarly potent effects on outcomes.Chronic low back pain is the most prevalent chronic pain condition among adults worldwide.18 Patient education on pain self-management and multisession cognitive behavioral therapy (CBT) are recommended as first-line treatments for back pain,17 and the National Institute for Health and Care Excellence (NICE) guidelines recommend CBT integration into comprehensive care plans.27 Often, group-based CBT for chronic pain is delivered over eight 2-hour sessions (16 hours total treatment time). Content includes pain education, self-regulatory skills training, problem-solving and action planning, and home practice between sessions. Rigorous back pain studies8,38 and chronic pain meta-analyses41 suggest CBT has small-to-moderate effects for multidimensional symptom reduction in chronic pain. However, multiple barriers prevent broad access to CBT, such as physician referral, lack of insurance in the U.S., lack of trained professionals, extensive wait times, and burdens associated with multisession treatment. 11,25 Effective briefer options could ease care barriers, facilitate the implementation of recommended guidelines, and scale best practices to treat chronic low back pain.Empowered Relief (ER) is a 2-hour single-session pain relief skills intervention that includes cognitive behavioral skills acquisition, mindfulness principles, and pain neuroscience education.10,12,13 Previously, we conducted a three-arm randomized controlled trial in 263 community adults with chronic low back pain in which we compared 2-hour ER, a 2-hour back health education (HE) class, and an 8-session back pain CBT protocol (16 hours of total treatment time).7,8 In this trial, pain catastrophizing, a cognitive and emotional pain response pattern that includes increased attention, and feelings of pain helplessness, was selected as the primary outcome because of its impacts on the intensity and trajectory of chronic pain6,39 and responsiveness to CBT.38,40,41 Results revealed noninferiority in outcome potency of a 2-hour pain relief skills intervention compared with a standard course of an 8-session CBT at 3 months posttreatment. Specifically, ER was noninferior to an 8-session CBT for reducing pain catastrophizing, pain intensity, pain interference, pain bothersomeness, fatigue, sleep disturbance, anxiety, and depression; across variables, ER and CBT had moderate-to-large treatment effects that were superior to HE at 3 months.13 Such findings suggest that for some patients, brief psychosocial pain interventions may represent satisfactory alternatives to more lengthy and resource-intensive treatment, at least in the short-term. Evidence of extended efficacy of 1-session ER could inform broad treatment adoption in clinical practice, resource allocation, and third-party payer reimbursement in the U.S.Accordingly, the current report describes 6-month outcome data for our three-arm randomized comparative efficacy trial. First, we examined whether ER retained noninferiority to CBT and superiority to HE on baseline to 6-month posttreatment changes for primary and secondary outcomes. Results of these analyses also would indicate the relative position of an 8-session CBT and brief ER with respect to maintenance of longer-term effects. We hypothesized that at 6 months posttreatment, ER and CBT would be superior to HE and that ER would maintain noninferiority with CBT. Second, we examined the degree to which ER showed increments or decrements in outcome values from 3 months to 6 months posttreatment. Results of these analyses would indicate the degree to which effects of brief ER changed or maintained their absolute position from 3 months to 6 months posttreatment.We conducted this three-arm randomized comparative efficacy trial at a single academic site in the San Francisco Bay Area after trial preregistration4 and the published protocol.12 The trial tested for noninferiority in comparing a 1-session ER vs an 8-session CBT and superiority in comparing a 1-session ER vs a 1-session HE and an 8-session CBT vs a 1-session HE. The study protocol followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines on noninferiority trials (Fig. 1),31 was approved by Stanford's institutional review board, included a data and safety monitoring board, and the trial was overseen by an independent monitoring agency appointed by the National Institutes of Health.CONSORT diagram to 6 months posttreatment. CBT, cognitive behavioral therapy; ER, Empowered Relief; HE, health education. Introduction:We previously conducted a 3-arm randomized trial (263 adults with chronic low back pain) which compared group-based (1) single-session pain relief skills intervention (Empowered Relief; ER); (2) 8-session cognitive behavioral therapy (CBT) for chronic back pain; and (3) single-session health and back pain education class (HE). Results suggested non-inferiority of ER vs. CBT at 3 months post-treatment on an array of outcomes.Here, we tested the durability of treatment effects at 6 months post-treatment. We examined group differences in primary and secondary outcomes at 6 months and the degree to which outcomes eroded or improved from 3-month to 6-month within each treatment group.Empowered Relief remained non-inferior to CBT on most outcomes, whereas both ER and CBT remained superior to HE on most outcomes. Outcome improvements within ER did not decrease significantly from 3-month to 6-month, and indeed ER showed additional 3- to 6-month improvements on pain catastrophizing, pain bothersomeness, and anxiety. Effects of ER at 6 months post-treatment (moderate term outcomes) kept pace with effects reported by participants who underwent 8-session CBT.The maintenance of these absolute levels implies strong stability of ER effects. Results extend to 6 months post-treatment previous findings documenting that ER and CBT exhibit similarly potent effects on outcomes.Chronic low back pain is the most prevalent chronic pain condition among adults worldwide.18 Patient education on pain self-management and multisession cognitive behavioral therapy (CBT) are recommended as first-line treatments for back pain,17 and the National Institute for Health and Care Excellence (NICE) guidelines recommend CBT integration into comprehensive care plans.27 Often, group-based CBT for chronic pain is delivered over eight 2-hour sessions (16 hours total treatment time). Content includes pain education, self-regulatory skills training, problem-solving and action planning, and home practice between sessions. Rigorous back pain studies8,38 and chronic pain meta-analyses41 suggest CBT has small-to-moderate effects for multidimensional symptom reduction in chronic pain. However, multiple barriers prevent broad access to CBT, such as physician referral, lack of insurance in the U.S., lack of trained professionals, extensive wait times, and burdens associated with multisession treatment.11,25 Effective briefer options could ease care barriers, facilitate the implementation of recommended guidelines, and scale best practices to treat chronic low back pain.Empowered Relief (ER) is a 2-hour single-session pain relief skills intervention that includes cognitive behavioral skills acquisition, mindfulness principles, and pain neuroscience education.10,12,13 Previously, we conducted a three-arm randomized controlled trial in 263 community adults with chronic low back pain in which we compared 2-hour ER, a 2-hour back health education (HE) class, and an 8-session back pain CBT protocol (16 hours of total treatment time).7,8 In this trial, pain catastrophizing, a cognitive and emotional pain response pattern that includes increased attention, and feelings of pain helplessness, was selected as the primary outcome because of its impacts on the intensity and trajectory of chronic pain6,39 and responsiveness to CBT.38,40,41 Results revealed noninferiority in outcome potency of a 2-hour pain relief skills intervention compared with a standard course of an 8-session CBT at 3 months posttreatment. Specifically, ER was noninferior to an 8-session CBT for reducing pain catastrophizing, pain intensity, pain interference, pain bothersomeness, fatigue, sleep disturbance, anxiety, and depression; across variables, ER and CBT had moderate-to-large treatment effects that were superior to HE at 3 months.13 Such findings suggest that for some patients, brief psychosocial pain interventions may represent satisfactory alternatives to more lengthy and resource-intensive treatment, at least in the short-term. Evidence of extended efficacy of 1-session ER could inform broad treatment adoption in clinical practice, resource allocation, and third-party payer reimbursement in the U.S.Accordingly, the current report describes 6-month outcome data for our three-arm randomized comparative efficacy trial. First, we examined whether ER retained noninferiority to CBT and superiority to HE on baseline to 6-month posttreatment changes for primary and secondary outcomes. Results of these analyses also would indicate the relative position of an 8-session CBT and brief ER with respect to maintenance of longer-term effects. We hypothesized that at 6 months posttreatment, ER and CBT would be superior to HE and that ER would maintain noninferiority with CBT. Second, we examined the degree to which ER showed increments or decrements in outcome values from 3 months to 6 months posttreatment. Results of these analyses would indicate the degree to which effects of brief ER changed or maintained their absolute position from 3 months to 6 months posttreatment.We conducted this three-arm randomized comparative efficacy trial at a single academic site in the San Francisco Bay Area after trial preregistration4 and the published protocol.12 The trial tested for noninferiority in comparing a 1-session ER vs an 8-session CBT and superiority in comparing a 1-session ER vs a 1-session HE and an 8-session CBT vs a 1-session HE. The study protocol followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines on noninferiority trials (Fig. 1),31 was approved by Stanford's institutional review board, included a data and safety monitoring board, and the trial was overseen by an independent monitoring agency appointed by the National Institutes of Health.CONSORT diagram to 6 months posttreatment. CBT, cognitive behavioral therapy; ER, Empowered Relief; HE, health education.Introduction:We previously conducted a 3-arm randomized trial (263 adults with chronic low back pain) which compared group-based (1) single-session pain relief skills intervention (Empowered Relief; ER); (2) 8-session cognitive behavioral therapy (CBT) for chronic back pain; and (3) single-session health and back pain education class (HE). Results suggested non-inferiority of ER vs. CBT at 3 months post-treatment on an array of outcomes.Here, we tested the durability of treatment effects at 6 months post-treatment. We examined group differences in primary and secondary outcomes at 6 months and the degree to which outcomes eroded or improved from 3-month to 6-month within each treatment group.Empowered Relief remained non-inferior to CBT on most outcomes, whereas both ER and CBT remained superior to HE on most outcomes. Outcome improvements within ER did not decrease significantly from 3-month to 6-month, and indeed ER showed additional 3- to 6-month improvements on pain catastrophizing, pain bothersomeness, and anxiety. Effects of ER at 6 months post-treatment (moderate term outcomes) kept pace with effects reported by participants who underwent 8-session CBT. The maintenance of these absolute levels implies strong stability of ER effects. Results extend to 6 months post-treatment previous findings documenting that ER and CBT exhibit similarly potent effects on outcomes.Chronic low back pain is the most prevalent chronic pain condition among adults worldwide.18 Patient education on pain self-management and multisession cognitive behavioral therapy (CBT) are recommended as first-line treatments for back pain,17 and the National Institute for Health and Care Excellence (NICE) guidelines recommend CBT integration into comprehensive care plans.27 Often, group-based CBT for chronic pain is delivered over eight 2-hour sessions (16 hours total treatment time). Content includes pain education, self-regulatory skills training, problem-solving and action planning, and home practice between sessions. Rigorous back pain studies8,38 and chronic pain meta-analyses41 suggest CBT has small-to-moderate effects for multidimensional symptom reduction in chronic pain. However, multiple barriers prevent broad access to CBT, such as physician referral, lack of insurance in the U.S., lack of trained professionals, extensive wait times, and burdens associated with multisession treatment.11,25 Effective briefer options could ease care barriers, facilitate the implementation of recommended guidelines, and scale best practices to treat chronic low back pain.Empowered Relief (ER) is a 2-hour single-session pain relief skills intervention that includes cognitive behavioral skills acquisition, mindfulness principles, and pain neuroscience education.10,12,13 Previously, we conducted a three-arm randomized controlled trial in 263 community adults with chronic low back pain in which we compared 2-hour ER, a 2-hour back health education (HE) class, and an 8-session back pain CBT protocol (16 hours of total treatment time).7,8 In this trial, pain catastrophizing, a cognitive and emotional pain response pattern that includes increased attention, and feelings of pain helplessness, was selected as the primary outcome because of its impacts on the intensity and trajectory of chronic pain6,39 and responsiveness to CBT.38,40,41 Results revealed noninferiority in outcome potency of a 2-hour pain relief skills intervention compared with a standard course of an 8-session CBT at 3 months posttreatment. Specifically, ER was noninferior to an 8-session CBT for reducing pain catastrophizing, pain intensity, pain interference, pain bothersomeness, fatigue, sleep disturbance, anxiety, and depression; across variables, ER and CBT had moderate-to-large treatment effects that were superior to HE at 3 months.13 Such findings suggest that for some patients, brief psychosocial pain interventions may represent satisfactory alternatives to more lengthy and resource-intensive treatment, at least in the short-term. Evidence of extended efficacy of 1-session ER could inform broad treatment adoption in clinical practice, resource allocation, and third-party payer reimbursement in the U.S.Accordingly, the current report describes 6-month outcome data for our three-arm randomized comparative efficacy trial. First, we examined whether ER retained noninferiority to CBT and superiority to HE on baseline to 6-month posttreatment changes for primary and secondary outcomes. Results of these analyses also would indicate the relative position of an 8-session CBT and brief ER with respect to maintenance of longer-term effects. We hypothesized that at 6 months posttreatment, ER and CBT would be superior to HE and that ER would maintain noninferiority with CBT. Second, we examined the degree to which ER showed increments or decrements in outcome values from 3 months to 6 months posttreatment. Results of these analyses would indicate the degree to which effects of brief ER changed or maintained their absolute position from 3 months to 6 months posttreatment.We conducted this three-arm randomized comparative efficacy trial at a single academic site in the San Francisco Bay Area after trial preregistration4 and the published protocol.12 The trial tested for noninferiority in comparing a 1-session ER vs an 8-session CBT and superiority in comparing a 1-session ER vs a 1-session HE and an 8-session CBT vs a 1-session HE. The study protocol followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines on noninferiority trials (Fig. 1),31 was approved by Stanford's institutional review board, included a data and safety monitoring board, and the trial was overseen by an independent monitoring agency appointed by the National Institutes of Health.CONSORT diagram to 6 months posttreatment. CBT, cognitive behavioral therapy; ER, Empowered Relief; HE, health education.Introduction:We previously conducted a 3-arm randomized trial (263 adults with chronic low back pain) which compared group-based (1) single-session pain relief skills intervention (Empowered Relief; ER); (2) 8-session cognitive behavioral therapy (CBT) for chronic back pain; and (3) single-session health and back pain education class (HE). Results suggested non-inferiority of ER vs. CBT at 3 months post-treatment on an array of outcomes.Here, we tested the durability of treatment effects at 6 months post-treatment. We examined group differences in primary and secondary outcomes at 6 months and the degree to which outcomes eroded or improved from 3-month to 6-month within each treatment group.Empowered Relief remained non-inferior to CBT on most outcomes, whereas both ER and CBT remained superior to HE on most outcomes. Outcome improvements within ER did not decrease significantly from 3-month to 6-month, and indeed ER showed additional 3- to 6-month improvements on pain catastrophizing, pain bothersomeness, and anxiety. Effects of ER at 6 months post-treatment (moderate term outcomes) kept pace with effects reported by participants who underwent 8-session CBT.The maintenance of these absolute levels implies strong stability of ER effects. Results extend to 6 months post-treatment previous findings documenting that ER and CBT exhibit similarly potent effects on outcomes.Chronic low back pain is the most prevalent chronic pain condition among adults worldwide.18 Patient education on pain self-management and multisession cognitive behavioral therapy (CBT) are recommended as first-line treatments for back pain,17 and the National Institute for Health and Care Excellence (NICE) guidelines recommend CBT integration into comprehensive care plans.27 Often, group-based CBT for chronic pain is delivered over eight 2-hour sessions (16 hours total treatment time). Content includes pain education, self-regulatory skills training, problem-solving and action planning, and home practice between sessions. Rigorous back pain studies8,38 and chronic pain meta-analyses41 suggest CBT has small-to-moderate effects for multidimensional symptom reduction in chronic pain. However, multiple barriers prevent broad access to CBT, such as physician referral, lack of insurance in the U.S., lack of trained professionals, extensive wait times, and burdens associated with multisession treatment. 11,25 Effective briefer options could ease care barriers, facilitate the implementation of recommended guidelines, and scale best practices to treat chronic low back pain.Empowered Relief (ER) is a 2-hour single-session pain relief skills intervention that includes cognitive behavioral skills acquisition, mindfulness principles, and pain neuroscience education.10,12,13 Previously, we conducted a three-arm randomized controlled trial in 263 community adults with chronic low back pain in which we compared 2-hour ER, a 2-hour back health education (HE) class, and an 8-session back pain CBT protocol (16 hours of total treatment time).7,8 In this trial, pain catastrophizing, a cognitive and emotional pain response pattern that includes increased attention, and feelings of pain helplessness, was selected as the primary outcome because of its impacts on the intensity and trajectory of chronic pain6,39 and responsiveness to CBT.38,40,41 Results revealed noninferiority in outcome potency of a 2-hour pain relief skills intervention compared with a standard course of an 8-session CBT at 3 months posttreatment. Specifically, ER was noninferior to an 8-session CBT for reducing pain catastrophizing, pain intensity, pain interference, pain bothersomeness, fatigue, sleep disturbance, anxiety, and depression; across variables, ER and CBT had moderate-to-large treatment effects that were superior to HE at 3 months.13 Such findings suggest that for some patients, brief psychosocial pain interventions may represent satisfactory alternatives to more lengthy and resource-intensive treatment, at least in the short-term. Evidence of extended efficacy of 1-session ER could inform broad treatment adoption in clinical practice, resource allocation, and third-party payer reimbursement in the U.S.Accordingly, the current report describes 6-month outcome data for our three-arm randomized comparative efficacy trial. First, we examined whether ER retained noninferiority to CBT and superiority to HE on baseline to 6-month posttreatment changes for primary and secondary outcomes. Results of these analyses also would indicate the relative position of an 8-session CBT and brief ER with respect to maintenance of longer-term effects. We hypothesized that at 6 months posttreatment, ER and CBT would be superior to HE and that ER would maintain noninferiority with CBT. Second, we examined the degree to which ER showed increments or decrements in outcome values from 3 months to 6 months posttreatment. Results of these analyses would indicate the degree to which effects of brief ER changed or maintained their absolute position from 3 months to 6 months posttreatment.We conducted this three-arm randomized comparative efficacy trial at a single academic site in the San Francisco Bay Area after trial preregistration4 and the published protocol.12 The trial tested for noninferiority in comparing a 1-session ER vs an 8-session CBT and superiority in comparing a 1-session ER vs a 1-session HE and an 8-session CBT vs a 1-session HE. The study protocol followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines on noninferiority trials (Fig. 1),31 was approved by Stanford's institutional review board, included a data and safety monitoring board, and the trial was overseen by an independent monitoring agency appointed by the National Institutes of Health.CONSORT diagram to 6 months posttreatment. CBT, cognitive behavioral therapy; ER, Empowered Relief; HE, health education. Introduction:We previously conducted a 3-arm randomized trial (263 adults with chronic low back pain) which compared group-based (1) single-session pain relief skills intervention (Empowered Relief; ER); (2) 8-session cognitive behavioral therapy (CBT) for chronic back pain; and (3) single-session health and back pain education class (HE). Results suggested non-inferiority of ER vs. CBT at 3 months post-treatment on an array of outcomes.Here, we tested the durability of treatment effects at 6 months post-treatment. We examined group differences in primary and secondary outcomes at 6 months and the degree to which outcomes eroded or improved from 3-month to 6-month within each treatment group.Empowered Relief remained non-inferior to CBT on most outcomes, whereas both ER and CBT remained superior to HE on most outcomes. Outcome improvements within ER did not decrease significantly from 3-month to 6-month, and indeed ER showed additional 3- to 6-month improvements on pain catastrophizing, pain bothersomeness, and anxiety. Effects of ER at 6 months post-treatment (moderate term outcomes) kept pace with effects reported by participants who underwent 8-session CBT.The maintenance of these absolute levels implies strong stability of ER effects. Results extend to 6 months post-treatment previous findings documenting that ER and CBT exhibit similarly potent effects on outcomes.Chronic low back pain is the most prevalent chronic pain condition among adults worldwide.18 Patient education on pain self-management and multisession cognitive behavioral therapy (CBT) are recommended as first-line treatments for back pain,17 and the National Institute for Health and Care Excellence (NICE) guidelines recommend CBT integration into comprehensive care plans.27 Often, group-based CBT for chronic pain is delivered over eight 2-hour sessions (16 hours total treatment time). Content includes pain education, self-regulatory skills training, problem-solving and action planning, and home practice between sessions. Rigorous back pain studies8,38 and chronic pain meta-analyses41 suggest CBT has small-to-moderate effects for multidimensional symptom reduction in chronic pain. However, multiple barriers prevent broad access to CBT, such as physician referral, lack of insurance in the U.S., lack of trained professionals, extensive wait times, and burdens associated with multisession treatment.11,25 Effective briefer options could ease care barriers, facilitate the implementation of recommended guidelines, and scale best practices to treat chronic low back pain.Empowered Relief (ER) is a 2-hour single-session pain relief skills intervention that includes cognitive behavioral skills acquisition, mindfulness principles, and pain neuroscience education.10,12,13 Previously, we conducted a three-arm randomized controlled trial in 263 community adults with chronic low back pain in which we compared 2-hour ER, a 2-hour back health education (HE) class, and an 8-session back pain CBT protocol (16 hours of total treatment time).7,8 In this trial, pain catastrophizing, a cognitive and emotional pain response pattern that includes increased attention, and feelings of pain helplessness, was selected as the primary outcome because of its impacts on the intensity and trajectory of chronic pain6,39 and responsiveness to CBT.38,40,41 Results revealed noninferiority in outcome potency of a 2-hour pain relief skills intervention compared with a standard course of an 8-session CBT at 3 months posttreatment. Specifically, ER was noninferior to an 8-session CBT for reducing pain catastrophizing, pain intensity, pain interference, pain bothersomeness, fatigue, sleep disturbance, anxiety, and depression; across variables, ER and CBT had moderate-to-large treatment effects that were superior to HE at 3 months.13 Such findings suggest that for some patients, brief psychosocial pain interventions may represent satisfactory alternatives to more lengthy and resource-intensive treatment, at least in the short-term. Evidence of extended efficacy of 1-session ER could inform broad treatment adoption in clinical practice, resource allocation, and third-party payer reimbursement in the U.S.Accordingly, the current report describes 6-month outcome data for our three-arm randomized comparative efficacy trial. First, we examined whether ER retained noninferiority to CBT and superiority to HE on baseline to 6-month posttreatment changes for primary and secondary outcomes. Results of these analyses also would indicate the relative position of an 8-session CBT and brief ER with respect to maintenance of longer-term effects. We hypothesized that at 6 months posttreatment, ER and CBT would be superior to HE and that ER would maintain noninferiority with CBT. Second, we examined the degree to which ER showed increments or decrements in outcome values from 3 months to 6 months posttreatment. Results of these analyses would indicate the degree to which effects of brief ER changed or maintained their absolute position from 3 months to 6 months posttreatment.We conducted this three-arm randomized comparative efficacy trial at a single academic site in the San Francisco Bay Area after trial preregistration4 and the published protocol.12 The trial tested for noninferiority in comparing a 1-session ER vs an 8-session CBT and superiority in comparing a 1-session ER vs a 1-session HE and an 8-session CBT vs a 1-session HE. The study protocol followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines on noninferiority trials (Fig. 1),31 was approved by Stanford's institutional review board, included a data and safety monitoring board, and the trial was overseen by an independent monitoring agency appointed by the National Institutes of Health.CONSORT diagram to 6 months posttreatment. CBT, cognitive behavioral therapy; ER, Empowered Relief; HE, health education.Introduction:We previously conducted a 3-arm randomized trial (263 adults with chronic low back pain) which compared group-based (1) single-session pain relief skills intervention (Empowered Relief; ER); (2) 8-session cognitive behavioral therapy (CBT) for chronic back pain; and (3) single-session health and back pain education class (HE). Results suggested non-inferiority of ER vs. CBT at 3 months post-treatment on an array of outcomes.Here, we tested the durability of treatment effects at 6 months post-treatment. We examined group differences in primary and secondary outcomes at 6 months and the degree to which outcomes eroded or improved from 3-month to 6-month within each treatment group.Empowered Relief remained non-inferior to CBT on most outcomes, whereas both ER and CBT remained superior to HE on most outcomes. Outcome improvements within ER did not decrease significantly from 3-month to 6-month, and indeed ER showed additional 3- to 6-month improvements on pain catastrophizing, pain bothersomeness, and anxiety. Effects of ER at 6 months post-treatment (moderate term outcomes) kept pace with effects reported by participants who underwent 8-session CBT. The maintenance of these absolute levels implies strong stability of ER effects. Results extend to 6 months post-treatment previous findings documenting that ER and CBT exhibit similarly potent effects on outcomes.Chronic low back pain is the most prevalent chronic pain condition among adults worldwide.18 Patient education on pain self-management and multisession cognitive behavioral therapy (CBT) are recommended as first-line treatments for back pain,17 and the National Institute for Health and Care Excellence (NICE) guidelines recommend CBT integration into comprehensive care plans.27 Often, group-based CBT for chronic pain is delivered over eight 2-hour sessions (16 hours total treatment time). Content includes pain education, self-regulatory skills training, problem-solving and action planning, and home practice between sessions. Rigorous back pain studies8,38 and chronic pain meta-analyses41 suggest CBT has small-to-moderate effects for multidimensional symptom reduction in chronic pain. However, multiple barriers prevent broad access to CBT, such as physician referral, lack of insurance in the U.S., lack of trained professionals, extensive wait times, and burdens associated with multisession treatment.11,25 Effective briefer options could ease care barriers, facilitate the implementation of recommended guidelines, and scale best practices to treat chronic low back pain.Empowered Relief (ER) is a 2-hour single-session pain relief skills intervention that includes cognitive behavioral skills acquisition, mindfulness principles, and pain neuroscience education.10,12,13 Previously, we conducted a three-arm randomized controlled trial in 263 community adults with chronic low back pain in which we compared 2-hour ER, a 2-hour back health education (HE) class, and an 8-session back pain CBT protocol (16 hours of total treatment time).7,8 In this trial, pain catastrophizing, a cognitive and emotional pain response pattern that includes increased attention, and feelings of pain helplessness, was selected as the primary outcome because of its impacts on the intensity and trajectory of chronic pain6,39 and responsiveness to CBT.38,40,41 Results revealed noninferiority in outcome potency of a 2-hour pain relief skills intervention compared with a standard course of an 8-session CBT at 3 months posttreatment. Specifically, ER was noninferior to an 8-session CBT for reducing pain catastrophizing, pain intensity, pain interference, pain bothersomeness, fatigue, sleep disturbance, anxiety, and depression; across variables, ER and CBT had moderate-to-large treatment effects that were superior to HE at 3 months.13 Such findings suggest that for some patients, brief psychosocial pain interventions may represent satisfactory alternatives to more lengthy and resource-intensive treatment, at least in the short-term. Evidence of extended efficacy of 1-session ER could inform broad treatment adoption in clinical practice, resource allocation, and third-party payer reimbursement in the U.S.Accordingly, the current report describes 6-month outcome data for our three-arm randomized comparative efficacy trial. First, we examined whether ER retained noninferiority to CBT and superiority to HE on baseline to 6-month posttreatment changes for primary and secondary outcomes. Results of these analyses also would indicate the relative position of an 8-session CBT and brief ER with respect to maintenance of longer-term effects. We hypothesized that at 6 months posttreatment, ER and CBT would be superior to HE and that ER would maintain noninferiority with CBT. Second, we examined the degree to which ER showed increments or decrements in outcome values from 3 months to 6 months posttreatment. Results of these analyses would indicate the degree to which effects of brief ER changed or maintained their absolute position from 3 months to 6 months posttreatment.We conducted this three-arm randomized comparative efficacy trial at a single academic site in the San Francisco Bay Area after trial preregistration4 and the published protocol.12 The trial tested for noninferiority in comparing a 1-session ER vs an 8-session CBT and superiority in comparing a 1-session ER vs a 1-session HE and an 8-session CBT vs a 1-session HE. The study protocol followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines on noninferiority trials (Fig. 1),31 was approved by Stanford's institutional review board, included a data and safety monitoring board, and the trial was overseen by an independent monitoring agency appointed by the National Institutes of Health.CONSORT diagram to 6 months posttreatment. CBT, cognitive behavioral therapy; ER, Empowered Relief; HE, health education.Introduction:We previously conducted a 3-arm randomized trial (263 adults with chronic low back pain) which compared group-based (1) single-session pain relief skills intervention (Empowered Relief; ER); (2) 8-session cognitive behavioral therapy (CBT) for chronic back pain; and (3) single-session health and back pain education class (HE). Results suggested non-inferiority of ER vs. CBT at 3 months post-treatment on an array of outcomes.Here, we tested the durability of treatment effects at 6 months post-treatment. We examined group differences in primary and secondary outcomes at 6 months and the degree to which outcomes eroded or improved from 3-month to 6-month within each treatment group.Empowered Relief remained non-inferior to CBT on most outcomes, whereas both ER and CBT remained superior to HE on most outcomes. Outcome improvements within ER did not decrease significantly from 3-month to 6-month, and indeed ER showed additional 3- to 6-month improvements on pain catastrophizing, pain bothersomeness, and anxiety. Effects of ER at 6 months post-treatment (moderate term outcomes) kept pace with effects reported by participants who underwent 8-session CBT.The maintenance of these absolute levels implies strong stability of ER effects. Results extend to 6 months post-treatment previous findings documenting that ER and CBT exhibit similarly potent effects on outcomes.Chronic low back pain is the most prevalent chronic pain condition among adults worldwide.18 Patient education on pain self-management and multisession cognitive behavioral therapy (CBT) are recommended as first-line treatments for back pain,17 and the National Institute for Health and Care Excellence (NICE) guidelines recommend CBT integration into comprehensive care plans.27 Often, group-based CBT for chronic pain is delivered over eight 2-hour sessions (16 hours total treatment time). Content includes pain education, self-regulatory skills training, problem-solving and action planning, and home practice between sessions. Rigorous back pain studies8,38 and chronic pain meta-analyses41 suggest CBT has small-to-moderate effects for multidimensional symptom reduction in chronic pain. However, multiple barriers prevent broad access to CBT, such as physician referral, lack of insurance in the U.S., lack of trained professionals, extensive wait times, and burdens associated with multisession treatment. 11,25 Effective briefer options could ease care barriers, facilitate the implementation of recommended guidelines, and scale best practices to treat chronic low back pain.Empowered Relief (ER) is a 2-hour single-session pain relief skills intervention that includes cognitive behavioral skills acquisition, mindfulness principles, and pain neuroscience education.10,12,13 Previously, we conducted a three-arm randomized controlled trial in 263 community adults with chronic low back pain in which we compared 2-hour ER, a 2-hour back health education (HE) class, and an 8-session back pain CBT protocol (16 hours of total treatment time).7,8 In this trial, pain catastrophizing, a cognitive and emotional pain response pattern that includes increased attention, and feelings of pain helplessness, was selected as the primary outcome because of its impacts on the intensity and trajectory of chronic pain6,39 and responsiveness to CBT.38,40,41 Results revealed noninferiority in outcome potency of a 2-hour pain relief skills intervention compared with a standard course of an 8-session CBT at 3 months posttreatment. Specifically, ER was noninferior to an 8-session CBT for reducing pain catastrophizing, pain intensity, pain interference, pain bothersomeness, fatigue, sleep disturbance, anxiety, and depression; across variables, ER and CBT had moderate-to-large treatment effects that were superior to HE at 3 months.13 Such findings suggest that for some patients, brief psychosocial pain interventions may represent satisfactory alternatives to more lengthy and resource-intensive treatment, at least in the short-term. Evidence of extended efficacy of 1-session ER could inform broad treatment adoption in clinical practice, resource allocation, and third-party payer reimbursement in the U.S.Accordingly, the current report describes 6-month outcome data for our three-arm randomized comparative efficacy trial. First, we examined whether ER retained noninferiority to CBT and superiority to HE on baseline to 6-month posttreatment changes for primary and secondary outcomes. Results of these analyses also would indicate the relative position of an 8-session CBT and brief ER with respect to maintenance of longer-term effects. We hypothesized that at 6 months posttreatment, ER and CBT would be superior to HE and that ER would maintain noninferiority with CBT. Second, we examined the degree to which ER showed increments or decrements in outcome values from 3 months to 6 months posttreatment. Results of these analyses would indicate the degree to which effects of brief ER changed or maintained their absolute position from 3 months to 6 months posttreatment.We conducted this three-arm randomized comparative efficacy trial at a single academic site in the San Francisco Bay Area after trial preregistration4 and the published protocol.12 The trial tested for noninferiority in comparing a 1-session ER vs an 8-session CBT and superiority in comparing a 1-session ER vs a 1-session HE and an 8-session CBT vs a 1-session HE. The study protocol followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines on noninferiority trials (Fig. 1),31 was approved by Stanford's institutional review board, included a data and safety monitoring board, and the trial was overseen by an independent monitoring agency appointed by the National Institutes of Health.CONSORT diagram to 6 months posttreatment. CBT, cognitive behavioral therapy; ER, Empowered Relief; HE, health education.