Using Daily Ratings to Examine Treatment Dose and Response in Cognitive Behavioral Therapy for Chronic Pain: A Secondary Analysis of the Co-Operative Pain Education and Self-Management Clinical Trial.

BACKGROUND: Cognitive behavioral therapy for chronic pain (CBT-CP) has a strong evidence base, but little is known about when treatment benefits are achieved. The present study is a secondary analysis of individuals with chronic back pain recruited for a noninferiority trial comparing interactive voice response (IVR) CBT-CP with in-person CBT-CP. METHODS: On the basis of data from daily IVR surveys, a clinically meaningful change was defined as a 30% reduction in pain intensity (n = 108) or a 45% increase in daily steps (n = 104) compared with the baseline week. We identified individuals who achieved a meaningful change at any point during treatment, and then we compared those who maintained a meaningful change in their final treatment week (i.e., responders) with those who did not or who achieved a meaningful change but lapsed (i.e., nonresponders). RESULTS: During treatment, 46% of participants achieved a clinically meaningful decrease in pain intensity, and 66% achieved a clinically significant increase in number of steps per day. A total of 54% of patients were classified as responders in terms of decreases in pain intensity, and 70% were responders in terms of increases in step count. Survival analyses found that 50% of responders first achieved a clinically meaningful change by week 4 for pain intensity and week 2 for daily steps. Dropout and demographic variables were unrelated to responder status, and there was low agreement between the two measures of treatment response. CONCLUSIONS: Collectively, results suggest that most responders improve within 4 weeks. Evaluating treatment response is highly specific to the outcome measure, with little correlation across outcomes.

Pre-implementation formative evaluation of cooperative pain education and self-management expanding treatment for real-world access: A pragmatic pain trial.

OBJECTIVE: Cognitive behavioral therapy for chronic pain (CBT-CP) is an evidence-based treatment for improving functioning and pain intensity for people with chronic pain with extensive evidence of effectiveness. However, there has been relatively little investigation of the factors associated with successful implementation and uptake of CBT-CP, particularly clinician and system level factors. This formative evaluation examined barriers and facilitators to the successful implementation and uptake of CBT-CP from the perspective of CBT-CP clinicians and referring primary care clinicians. METHODS: Qualitative interviews guided by the Consolidated Framework for Implementation Research were conducted at nine geographically diverse Veterans Affairs sites as part of a pragmatic clinical trial comparing synchronous, clinician-delivered CBT-CP and remotely delivered, technology-assisted CBT-CP. Analysis was informed by a grounded theory approach. RESULTS: Twenty-six clinicians (CBT-CP clinicians = 17, primary care clinicians = 9) from nine VA medical centers participated in individual qualitative interviews conducted by telephone from April 2019 to August 2020. Four themes emerged in the qualitative interviews: (1) the complexity and variability of referral pathways across sites, (2) referring clinician's lack of knowledge about CBT-CP, (3) referring clinician's difficulty identifying suitable candidates for CBT-CP, and (4) preference for interventions that can be completed from home. CONCLUSIONS: This formative evaluation identified clinician and system barriers to widespread implementation of CBT-CP and allowed for refinement of the subsequent implementation of two forms of CBT-CP in an ongoing pragmatic trial. Identification of relative difference in barriers and facilitators in the two forms of CBT-CP may emerge more clearly in a pragmatic trial that evaluates how treatments perform in real-world settings and may provide important information to guide future system-wide implementation efforts.

Risk Factors Associated with Healthcare Utilization for Spine Pain.

OBJECTIVE: This study examined potential risk factors associated with healthcare utilization among patients with spine (i.e., neck and back) pain. METHODS: A two-stage sampling approach examined spine pain episodes of care among veterans with a yearly outpatient visit for six consecutive years. Descriptive and bivariate statistics, followed by logistic regression analyses, examined baseline characteristics of veterans with new episodes of care who either continued or discontinued spine pain care. A multivariable logistic regression model examined correlates associated with seeking continued spine pain care. RESULTS: Among 331,908 veterans without spine pain episodes of care during the 2-year baseline observation period, 16.5% (n = 54,852) had a new episode of care during the following 2-year observation period. Of those 54,852 veterans, 37,025 had an outpatient visit data during the final 2-year follow-up period, with 53.7% (n = 19,865) evidencing continued spine pain care. Those with continued care were more likely to be overweight or obese, non-smokers, Army veterans, have higher education, and had higher rates of diagnoses of all medical and mental health conditions examined at baseline. Among several important findings, women had 13% lower odds of continued care during the final 2-year observation period, OR 0.87 (0.81, 0.95). CONCLUSIONS: A number of important demographics and clinical correlates were associated with increased likelihood of seeking new and continued episodes of care for spine pain; however, further examination of risk factors associated with healthcare utilization for spine pain is indicated.

ICD-10 Coding of Musculoskeletal Conditions in the Veterans Health Administration.

OBJECTIVE: We describe the most frequently used musculoskeletal diagnoses in Veterans Health Administration care. We report the number of visits and patients associated with common musculoskeletal International Classification of Diseases (ICD)-10 codes and compare trends across primary and specialty care settings. DESIGN: Secondary analysis of a longitudinal cohort study. SUBJECTS: Veterans included in the Musculoskeletal Diagnosis Cohort with a musculoskeletal diagnosis from October 1, 2015, through September 30, 2017. METHODS: We obtained counts and proportions of all musculoskeletal diagnosis codes used and the number of unique patients with each musculoskeletal diagnosis. Diagnosis use was compared between primary and specialty care settings. RESULTS: Of more than 6,400 possible ICD-10 M-codes describing "Diseases of the Musculoskeletal System and Connective Tissue," 5,723 codes were used at least once. The most frequently used ICD-10 M-code was "Low Back Pain" (18.3%), followed by "Cervicalgia" (3.6%). Collectively, the 100 most frequently used codes accounted for 80% of M-coded visit diagnoses, and 95% of patients had at least one of these diagnoses. The most common diagnoses (spinal pain, joint pain, osteoarthritis) were used similarly in primary and specialty care settings. CONCLUSION: A diverse sample of all available musculoskeletal diagnosis codes were used; however, less than 2% of all possible codes accounted for 80% of the diagnoses used. This trend was consistent across primary and specialty care settings. The most frequently used diagnosis codes describe the types of musculoskeletal conditions, among a large pool of potential diagnoses, that prompt veterans to present to the Veterans Health Administration for musculoskeletal care.

Incorporating walking into cognitive behavioral therapy for chronic pain: safety and effectiveness of a personalized walking intervention.

We examined the effectiveness and safety of a walking program offered as part of cognitive behavioral therapy for chronic pain (CBT-CP). Participants were randomized to 10 weeks of CBT-CP, delivered either in person or by interactive voice response. Participants reported pedometer-measured step counts daily throughout treatment and received a weekly goal to increase their steps by 10% over the prior week's average. Walking-related adverse events (AEs) were assessed weekly. Participants (n = 125) were primarily male (72%), and white (80%) with longstanding pain (median: 11 years). There was no significant difference between treatment groups in rate of change in daily steps, but there was a significant increase in steps from baseline to treatment termination in the combined study sample (1648 steps (95% CI 1063-2225)). Participants classified as active doubled. AEs were mostly minor and temporary. Treatment was effective and safe whether the program was delivered in-person or remotely.Trial registration number: clinicaltrials.gov identifier: NCT01025752.

Co-Operative Pain Education and Self-management (COPES) Expanding Treatment for Real-World Access (ExTRA): Pragmatic Trial Protocol.

BACKGROUND: Given access barriers to cognitive behavioral therapy for chronic pain (CBT-CP), this pragmatic superiority trial will determine whether a remotely delivered CBT-CP intervention that addresses these barriers outperforms in-person and other synchronous forms of CBT-CP for veterans with musculoskeletal pain. DESIGN: This pragmatic trial compares an asynchronous form of CBT-CP that uses interactive voice response (IVR) to allow patients to participate from their home (IVR CBT-CP) with synchronous CBT-CP delivered by a Department of Veterans Affairs (VA) clinician. Veterans (n=764; 50% male) with chronic musculoskeletal pain throughout nine VA medical centers will participate. The primary outcome is pain interference after treatment (4 months). Secondary outcomes, including pain intensity, depression symptom severity, sleep, self-efficacy, and global impression of change, are also measured after treatment. Where possible, outcomes are collected via electronic health record extraction, with remaining measures collected via IVR calls to maintain blinding. Quantitative and qualitative process evaluation metrics will be collected to evaluate factors related to implementation. A budget impact analysis will be performed. SUMMARY: This pragmatic trial compares the outcomes, cost, and implementation of two forms of CBT-CP as delivered in the real-world setting. Findings from the trial can be used to guide future policy and implementation efforts related to these interventions and their use in the health system. If one of the interventions emerges as superior, resources can be directed to this modality. If both treatments are effective, patient preferences and health care system factors will take precedence when making referrals. Implications of COVID-19 on treatment provision and trial outcomes are discussed.

The Relationship Between Body Mass Index and Pain Intensity Among Veterans with Musculoskeletal Disorders: Findings from the MSD Cohort Study.

OBJECTIVE: To examine the relationship between body mass index (BMI) and pain intensity among veterans with musculoskeletal disorder diagnoses (MSDs; nontraumatic joint disorder; osteoarthritis; low back, back, and neck pain). SETTING: Administrative and electronic health record data from the Veterans Health Administration (VHA). SUBJECTS: A national cohort of US military veterans with MSDs in VHA care during 2001-2012 (N = 1,759,338). METHODS: These cross-sectional data were analyzed using hurdle negative binomial models of pain intensity as a function of BMI, adjusted for comorbidities and demographics. RESULTS: The sample had a mean age of 59.4, 95% were male, 77% were white/Non-Hispanic, 79% were overweight or obese, and 42% reported no pain at index MSD diagnosis. Overall, there was a J-shaped relationship between BMI and pain (nadir = 27 kg/m2), with the severely obese (BMI ≥ 40 kg/m2) being most likely to report any pain (OR vs normal weight = 1.23, 95% confidence interval = 1.21-1.26). The association between BMI and pain varied by MSD, with a stronger relationship in the osteoarthritis group and a less pronounced relationship in the back and low back pain groups. CONCLUSIONS: There was a high prevalence of overweight/obesity among veterans with MSD. High levels of BMI (>27 kg/m2) were associated with increased odds of pain, most markedly among veterans with osteoarthritis.

Factors Associated With Posttraumatic Stress Disorder Among Veterans of Recent Wars Receiving Veterans Affairs Chiropractic Care.

OBJECTIVES: Post-traumatic stress disorder (PTSD) is thought to complicate pain management outcomes, which is consistent with the impact of other psychosocial factors in the biopsychosocial model of pain. This study aimed to identify patient sociodemographic and clinical characteristics associated with PTSD prevalence among veterans of Operations Enduring Freedom/Iraqi Freedom/New Dawn (OEF/OIF/OND) who received Veterans Affairs (VA) chiropractic care. METHODS: A cross-sectional analysis of electronic health record data from a national cohort study of OEF/OIF/OND veterans with at least 1 visit to a VA chiropractic clinic from 2001 to 2014 was performed. The primary outcome measure was a prior PTSD diagnosis. Variables including sex, race, age, body mass index, pain intensity, alcohol and substance use disorders, and smoking status were examined in association with PTSD diagnosis using logistic regression. RESULTS: We identified 14,025 OEF/OIF/OND veterans with at least 1 VA chiropractic visit, with a mean age of 38 years and 54.2% having a diagnosis of PTSD. Male sex (adjusted odds ratio [OR] = 1.23, 95% CI = 1.11-1.37), younger age (OR = 0.99, CI = 0.98-0.99), moderate-to-severe pain intensity (numerical rating scale ≥ 4) (OR = 1.72, CI = 1.59-1.87), body mass index ≥ 30 (OR = 1.34, CI = 1.24-1.45), current smoking (OR = 1.32, CI = 1.20-1.44), and having an alcohol or substance use disorder (OR = 4.51, CI = 4.01-5.08) were significantly associated with a higher likelihood of PTSD diagnosis. CONCLUSION: Post-traumatic stress disorder is a common comorbidity among OEF/OIF/OND veterans receiving VA chiropractic care and is significantly associated with several patient characteristics. Recognition of these factors is important for the appropriate diagnosis and management of veterans with PTSD seeking chiropractic treatment for pain conditions.

Internet-Based Pain Self-Management for Veterans: Feasibility and Preliminary Efficacy of the Pain EASE Program.

OBJECTIVE: To develop and test the feasibility and preliminary efficacy of a cognitive behavioral therapy-based, internet-delivered self-management program for chronic low back pain (cLBP) in veterans. METHODS: Phase I included program development, involving expert panel and participant feedback. Phase II was a single-arm feasibility and preliminary efficacy study of the Pain e-health for Activity, Skills, and Education (Pain EASE) program. Feasibility (ie, website use, treatment credibility, satisfaction) was measured using descriptive methods. Mixed models were used to assess mean within-subject changes from baseline to 10 weeks post-baseline in pain interference (primary outcome, West Haven-Yale Multidimensional Pain Inventory, scale of 0 to 6), pain intensity, mood, fatigue, sleep, and depression. RESULTS: Phase I participants (n = 15) suggested modifications including style changes, content reduction, additional "Test Your Knowledge" quizzes, and cognitive behavioral therapy skill practice monitoring form revisions for enhanced usability. In Phase II, participants (n = 58) were mostly male (93%) and White (60%), and had an average age of 55 years (standard deviation [SD] = 12) and moderate pain (mean score 5.9/10); 41 (71%) completed the post-baseline assessment. Participants (N = 58) logged on 6.1 (SD = 8.6) times over 10 weeks, and 85% reported being very or moderately satisfied with Pain EASE. Pain interference improved from a mean of 3.8 at baseline to 3.3 at 10 weeks (difference 0.5 [95% confidence interval 0.1 to 0.9], P = 0.008). Within-subject improvement also occurred for some secondary outcomes, including mood and depression symptoms. DISCUSSION: Veterans with cLBP may benefit from technology-delivered interventions, which may also reduce pain interference. Overall, veterans found that Pain EASE, an internet-based self-management program, is feasible and satisfactory for cLBP.

A Research Agenda for Advancing Non-pharmacological Management of Chronic Musculoskeletal Pain: Findings from a VHA State-of-the-art Conference.

Chronic pain is widely prevalent among Veterans and can have serious negative consequences for functional status and quality of life among other domains. The Veterans Health Administration (VHA) convened a state-of-the-art (SOTA) conference to develop research priorities for advancing the science and clinical practice of non-pharmacological management of chronic musculoskeletal pain. In this perspective article, we present the methods and consensus recommendations for research priorities emanating from the SOTA. In the months leading up to the SOTA, a core group of researchers defined four areas of focus: psychological/behavioral therapies; exercise/movement therapies; manual therapies; and models for delivering multi-modal pain care and divided into workgroups. Each workgroup, in their respective areas of focus, identified seminal studies capturing the state of the evidence. Herein, we present consensus recommendations ranging from efficacy to effectiveness to implementation/dissemination research depending on the state of the evidence as assessed by participants, including commentary on common elements across workgroups and future areas of innovation in study design, measurement, and outcome ascertainment.

Predictors of Participation in a Nonpharmacological Intervention for Chronic Back Pain.

Objective: Cognitive behavioral therapy for chronic pain (CBT-CP) has been identified as an evidence-based adjunct or alternative to opioid pain care. However, little is known about which patients participate in CBT-CP. This study examined predictors of enrollment in a noninferiority trial of in-person vs technology-based CBT-CP for patients with chronic back pain. Setting: A single Veterans Health Affairs (VHA) medical center. Subjects: Veterans with chronic back pain. Design and Methods: For eligible participants (N = 290), individual factors (demographics, distance from a VHA medical center, pain intensity, receipt of opioid prescription, and recruitment method) collected at trial screening were examined to identify predictors of enrollment (i.e., signed consent form). Of those who enrolled, duration of participation in the treatment portion of the study was examined. Results: Among eligible patients, 54% declined enrollment due to lack of interest. Regression analyses revealed that patients not in receipt of an opioid were more likely to enroll. The probability of being in the trial long enough to receive a "dose" of treatment (3 visits or more) was 0.76 (0.04). Conclusions: Overall, enrollment rates were low. However, most patients who enrolled in the study (102 of 134 signed consent) were retained and received a treatment dose. Patients not receiving opioids were more likely to enroll, suggesting that patients who are prescribed opioids, an important group for treatment outreach, are likely underengaged. Identifying predictors of enrollment in CBT-CP may help increase recruitment efficiency and assist in targeting patients who may benefit but are not currently interested in treatment.

Project STEP: Implementing the Veterans Health Administration's Stepped Care Model of Pain Management.

Objective: The "stepped care model of pain management" (SCM-PM) prioritizes the role of primary care providers in optimizing pharmacological management and timely and equitable access to patient-centered, evidence-based nonpharmacological approaches, when indicated. Over the past several years, the Veterans Health Administration (VHA) has supported implementation of SCM-PM, but few data exist regarding changes in pain care resulting from implementation. We examined trends in prescribing and referral practices of primary care providers with hypotheses of decreased opioid prescribing, increased nonopioid prescribing, and increased referrals to specialty care for nonpharmacological services. Design: An initiative was designed to foster implementation and systematic evaluation of the SCM-PM over a five-year period at the VA Connecticut Healthcare System (VACHS) while fostering collaborative, partnered initiatives to promote organizational improvements in the delivery of pain care. Subjects: Participants were veterans receiving care at VACHS with at least one pain intensity rating ≥4/10 over the course of the study period (7/2008-6/2013). Methods: We used electronic health record data to examine changes in indicators of pain care including pharmacy and health care utilization data. Results: We observed hypothesized changes in long-term opioid and nonopioid analgesic prescribing and increased utilization of nonpharmacological treatments such as physical therapy, occupational therapy, and clinical health psychology. Conclusions: Through a multifaceted comprehensive implementation approach, primary care providers demonstrated increases in guideline-concordant pain care practices. Findings suggest that engagement of interdisciplinary teams and partnerships to promote organizational improvements is a useful strategy to increase the use of integrated, multimodal pain care for veterans, consistent with VHA's SCM-PM.

Developing a typology of patient-generated behavioral goals for cognitive behavioral therapy for chronic pain (CBT-CP): classification and predicting outcomes.

Patient-generated treatment goals describe what patients value, yet the content of these goals, and the relationship among goal types, goal accomplishment, and treatment outcomes has received little examination. We used inductive sorting to categorize patient-generated goals made by 147 adults receiving cognitive-behavioral therapy for chronic pain. The resulting goal categories were: Physical Activity (29.0%), Functional Status (24.6%), Wellness (16.3%), Recreational Activities (11.3%), House/Yard Work (9.7%), Socializing (7.1%), and Work/School (2.0%). Next, we examined associations between number of goals by category, goal accomplishment, and clinically meaningful improvements in pain-related interference, pain intensity and depressive symptoms. Improvement in all outcome domains was related to goal accomplishment. Additionally, depressive symptoms were related to number of Physical Activity, House/Yard Work, Recreational Activities, and Wellness goals, whereas improved pain-intensity was significantly related to House/Yard Work. Classifying patient-generated goals facilitates investigation of the relationships among goal type, goal accomplishment and treatment outcomes.

Cigarette Smoking Status and Receipt of an Opioid Prescription Among Veterans of Recent Wars.

Objective: Cigarette smokers seeking treatment for chronic pain have higher rates of opioid use than nonsmokers. This study aims to examine whether veterans of Operations Enduring Freedom/Iraqi Freedom/New Dawn (OEF/OIF/OND) who smoke are more likely to receive an opioid prescription than nonsmokers, adjusting for current pain intensity. Design: Cross-sectional analysis of a cohort study of OEF/OIF/OND veterans who had at least one visit to a Veterans Health Administration primary care clinic between 2001 and 2012. Methods: Smoking status was defined as current, former, and never. Current pain intensity (+/- 30 days of smoking status), based on the 0-10 numeric rating scale, was categorized as no pain/mild (0-3) and moderate/severe (4-10). Opioid receipt was defined as at least one prescription filled +/- 30 days of smoking status. Results: We identified 406,954 OEF/OIF/OND veterans: The mean age was 30 years, 12.5% were women (n = 50,988), 66.3% reported no pain or mild pain intensity, 33.7% reported moderate or severe pain intensity, 37.2% were current smokers, and 16% were former smokers. Overall, 33,960 (8.3%) veterans received one or more opioid prescription. Current smoking (odds ratio [OR] = 1.56, 95% confidence interval [CI] = 1.52-1.61) and former smoking (OR = 1.27, 95% CI = 1.22-1.32) were associated with a higher likelihood of receipt of an opioid prescription compared with never smoking, after controlling for other covariates. Conclusions: We found an association between smoking status and receipt of an opioid prescription. The effect was stronger for current smokers than former smokers, highlighting the need to determine whether smoking cessation is associated with a reduction in opioid use among veterans.

Barriers and facilitators to use of non-pharmacological treatments in chronic pain.

BACKGROUND: Consensus guidelines recommend multi-modal chronic pain treatment with increased uptake of non-pharmacological pain treatment modalities (NPMs). We aimed to identify the barriers and facilitators to uptake of evidence-based NPMs from the perspectives of patients, nurses and primary care providers (PCPs). METHODS: We convened eight separate groups and engaged each in a Nominal Group Technique (NGT) in which participants: (1) created an individual list of barriers (and, in a subsequent round, facilitators) to uptake of NPMs; (2) compiled a group list from the individual lists; and (3) anonymously voted on the top three most important barriers and facilitators. In a separate process, research staff reviewed each group's responses and categorized them based on staff consensus. RESULTS: Overall, 26 patients (14 women) with chronic pain participated; their mean age was 55. Overall, 14 nurses and 12 PCPs participated. Seven healthcare professionals were men and 19 were women; the mean age was 45. We categorized barriers and facilitators as related to access, patient-provider interaction, treatment beliefs and support. Top-ranked patient-reported barriers included high cost, transportation problems and low motivation, while top-ranked facilitators included availability of a wider array of NPMs and a team-based approach that included follow-up. Top-ranked provider-reported barriers included inability to promote NPMs once opioid therapy was started and patient skepticism about efficacy of NPMs, while top-ranked facilitators included promotion of a facility-wide treatment philosophy and increased patient knowledge about risks and benefits of NPMs. CONCLUSIONS: In a multi-stakeholder qualitative study using NGT, we found a diverse array of potentially modifiable barriers and facilitators to NPM uptake that may serve as important targets for program development.

Cooperative pain education and self-management (COPES): study design and protocol of a randomized non-inferiority trial of an interactive voice response-based self-management intervention for chronic low back pain.

BACKGROUND: The Institute of Medicine report "Relieving Pain in America" recommends the promotion of patient self-management of pain for all people with pain. Given the high prevalence of chronic pain in the US, new strategies are needed to enhance access to cognitive behavioral therapy (CBT) and other evidence-based treatments designed to facilitate self-management of chronic pain conditions. Although CBT is efficacious, many patients have limited or no access to CBT. Technology-assisted delivery of CBT may improve access while maintaining efficacy. METHODS/DESIGN: We describe a randomized non-inferiority trial of interactive voice response (IVR)-based CBT for patients with chronic low back pain. This intervention uses daily IVR monitoring and weekly pre-recorded therapist feedback, based on patient-reported information, to provide treatment for patients at home. A total of 230 patients with chronic low back pain are being identified from a single statewide health system serving US military veterans. Participants are randomized to receive either ten weeks of in-person CBT or IVR-based CBT. The primary outcome is pain intensity as measured by the Numeric Rating Scale immediately post-treatment. Secondary outcomes include pain-related interference, emotional functioning, and quality of life measured immediately post treatment, and 6 and 9 months post recruitment. Exploratory objectives of the study are to examine: (1) potential mediators of impact on clinical outcomes (treatment retention, self-reported skill practice ratings, IVR call adherence, and treatment satisfaction); and (2) moderators of treatment engagement, adherence to therapist recommendations for pain coping skill practice, and effects on clinical outcomes. DISCUSSION: This non-inferiority trial may identify an alternative to resource intensive in-person CBT that allows many more patients to receive care while also increasing retention of those enrolled in the program. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01025752 . Registered 3 December 2009.

Trauma, social support, family conflict, and chronic pain in recent service veterans: does gender matter?

OBJECTIVE: Women veterans have a higher prevalence of chronic pain relative to men. One hypothesis is that differential combat and traumatic sexual experiences and attenuated levels of social support between men and women may differentially contribute to the development and perpetuation of pain. This investigation examined [1] gender differences in trauma, social support, and family conflict among veterans with chronic pain, and [2] whether trauma, social support, and family conflict were differentially associated with pain severity, pain interference, and depressive symptom severity as a function of gender. METHODS: Participants included 460 veterans (56% female) who served in support of recent conflicts, and who endorsed pain lasting 3 months or longer. Participants completed a baseline survey during participation in a longitudinal investigation. Self-report measures included pain severity, pain interference, depressive symptom severity, exposure to traumatic life events, emotional and tangible support, and family conflict. RESULTS: Relative to men, women veterans reporting chronic pain evidenced higher rates of childhood interpersonal trauma (51% vs 34%; P < 0.001) and military sexual trauma (54% vs 3%; P < 0.001), along with lower levels of combat exposure (10.00 vs 16.85, P < 0.001). Gender was found to be a moderator of the association of marital status, combat exposure, childhood interpersonal trauma, and family conflict with pain interference. It also moderated family conflict in the prediction of depressive symptoms. CONCLUSIONS: Results underscore the potential importance of developing and testing gender specific models of chronic pain that consider the relative roles of trauma, social support, and family conflict.

A partnered approach to opioid management, guideline concordant care and the stepped care model of pain management.

BACKGROUND: Pain is the most common presenting problem in primary care. Opioid therapy (OT) for chronic pain has increased dramatically over the past decade, as have related negative outcomes. Despite the development and dissemination of policy and clinical practice guidelines for pain management and OT, adoption has been variable. The Veterans Health Administration (VHA) has established a Stepped Care Model of Pain Management (SCM-PM) as an evidence-based framework and single standard of pain care to promote guideline-concordant care, but to date its adoption and related outcomes have not been systematically examined. OBJECTIVE: Our aim was to examine changes in care for Veterans receiving long-term OT for management of chronic pain over a four-year study period. DESIGN: As part of a comprehensive implementation evaluation of performance improvements, the current evaluation reports performance improvement outcomes related to pain management and OT over a four-year period. SUBJECTS: We studied Veterans receiving long-term (90+ consecutive days) OT through primary care. INTERVENTIONS: We engaged an interdisciplinary clinical-research team to develop and implement a multifaceted performance improvement approach that included interactive educational strategies and other organizational initiatives. MAIN MEASURES: We measured the proportion of patients receiving long-term OT; use of opioid risk mitigation strategies; referrals to pain-related specialty services; and use of non-opioid analgesics. KEY RESULTS: The proportion of patients receiving high-dose opioids decreased over four years (27.7 % to 24.7 %). The use of opioid risk mitigation strategies increased significantly. Referrals to physical therapy and chiropractic care and prescriptions for topical analgesics increased significantly, while referrals to the pain medicine specialty clinic decreased. CONCLUSIONS: We demonstrate improvements in the management of veterans receiving OT that are consistent with the SCM-PM and published practice guidelines. We highlight how partnerships among funders, researchers, clinicians, and administrators contributed to the project's design and implementation, and to the dissemination strategy and future directions for improving opioid management and pain care.

Efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) in Individuals With Chronic Pain and Opioid Use Disorder: Protocol for a Randomized Clinical Trial of a Digital Cognitive Behavioral Treatment.

BACKGROUND: Chronic pain is common among individuals with opioid use disorder (OUD) who are maintained on medications for OUD (MOUD; eg, buprenorphine or methadone). Chronic pain is associated with worse retention and higher levels of substance use. Treatment of individuals with chronic pain receiving MOUD can be challenging due to their increased clinical complexity. Given the acute and growing nature of the opioid crisis, MOUD is increasingly offered in a wide range of settings, where high-quality, clinician-delivered, empirically validated behavioral treatment for chronic pain may not be available. Therefore, digital treatments that support patient self-management of chronic pain and OUD have the potential for wider implementation to fill this gap. OBJECTIVE: This study aims to evaluate the efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT), an interactive digital treatment program with asynchronous coach feedback, compared to treatment as usual (TAU) in individuals with chronic pain and OUD receiving MOUD. METHODS: Adult participants (n=160) receiving MOUD and reporting bothersome or high-impact chronic pain will be recruited from outpatient opioid treatment programs in Connecticut (United States) and randomized 1:1 to either IMPACT+TAU or TAU only. Participants randomized to IMPACT+TAU will complete an interactive digital treatment that includes 9 modules promoting training in pain and addiction coping skills and a progressive walking program. The program is augmented with a weekly personalized voice message from a trained coach based on daily participant-reported pain intensity and interference, craving to use opioids, sleep quality, daily steps, pain self-efficacy, MOUD adherence, and engagement with IMPACT collected through digital surveys. Outcomes will be assessed at 3, 6, and 9 months post randomization. The primary outcome is MOUD retention at 3 months post randomization (ie, post treatment). Secondary outcomes include pain interference, physical functioning, MOUD adherence, substance use, craving, pain intensity, sleep disturbance, pain catastrophizing, and pain self-efficacy. Semistructured qualitative interviews with study participants (n=34) randomized to IMPACT (completers and noncompleters) will be conducted to evaluate the usability and quality of the program and its outcomes. RESULTS: The study has received institutional review board approval and began recruitment at 1 site in July 2022. Recruitment at a second site started in January 2023, with a third and final site anticipated to begin recruitment in January 2024. Data collection is expected to continue through June 2025. CONCLUSIONS: Establishing efficacy for a digital treatment for addiction and chronic pain that can be integrated into MOUD clinics will provide options for individuals with OUD, which reduce barriers to behavioral treatment. Participant feedback on the intervention will inform updates or modifications to improve engagement and efficacy. TRIAL REGISTRATION: ClinicalTrials.gov NCT05204576; https://clinicaltrials.gov/ct2/show/NCT05204576. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/54342.

Integrating cognitive bias modification for pain and opioid cues into medication for opioid use disorder clinical care: Feasibility, acceptability, and preliminary results.

BACKGROUND: Despite high co-occurrence, chronic pain is often unaddressed in treatment for opioid use disorder (OUD) and little is known about mechanisms that may underlie associations between pain and opioid use. Using an attentional bias (AB) task with both pain and opioid cues, we evaluated a cognitive bias modification (CBM) task administered during regularly scheduled medications for OUD (mOUD) dosing visits. The current study evaluated the feasibility, acceptability, and preliminary efficacy of the CBM task. Outcomes for AB tasks used traditional mean-based score and trial-level bias scores (TLBS). METHODS: In a double-blind, randomized controlled trial, 28 individuals with OUD and chronic pain engaged in mOUD were randomized to either CBM or an AB control condition and completed up to three tasks per week for four weeks. Standard AB task was completed at baseline and post-treatment. Participants completed feasibility and acceptability measures, and preliminary efficacy (i.e., change in AB) was assessed using ANOVA models. RESULTS: Participants attended 83.3% of scheduled sessions and generally reported the task was enjoyable, credible, and easy to complete. Preliminary results demonstrated a condition by time interaction highlighting a reduction in AB in the CBM group but not the control group in opioid TLBS variability (F[1,26]=5.01, p = .034) and pain TLBS towards (F[1,26]=6.42, p = .018) and pain TLBS variability (F[1,26]=5.24, p = .03). CONCLUSIONS: The current study supports integrating brief, computer-based tasks designed to reduce AB into mOUD clinical care. The preliminary results suggest that TLBS outcomes may be more sensitive to capture changes in AB; however, larger studies are required.