Background Approximately 20% to 50% of patients develop persistent pain after traumatic orthopaedic injuries. Psychosocial factors are an important predictor of persistent pain; however, there are no evidence-based, mind-body interventions to prevent persistent pain for this patient population. Questions/purposes (1) Does the Toolkit for Optimal Recovery after Injury (TOR) achieve a priori feasibility benchmarks in a multisite randomized control trial (RCT)? (2) Does TOR demonstrate a preliminary effect in improving pain, as well as physical and emotional function? Methods This pilot RCT of TOR versus a minimally enhanced usual care comparison group (MEUC) was conducted among 195 adults with an acute orthopaedic traumatic injury at risk for persistent pain at four geographically diverse Level 1 trauma centers between October 2021 to August 2023. Fifty percent (97 of 195) of participants were randomized to TOR (mean age 43 ± 17 years; 67% [65 of 97] women) and 50% (98) to MEUC (mean age 45 ± 16 years; 67% [66 of 98] women). In TOR, 24% (23 of 97) of patients were lost to follow-up, whereas in the MEUC, 17% (17 of 98) were lost. At 4 weeks, 78% (76 of 97) of patients in TOR and 95% (93 of 98) in the MEUC completed the assessments; by 12 weeks, 76% (74 of 97) of patients in TOR and 83% (81 of 98) in the MEUC completed the assessments (all participants were still included in the analysis consistent with an intention-to-treat approach). The TOR has four weekly video-administered sessions that teach pain coping skills. The MEUC is an educational pamphlet. Both were delivered in addition to usual care. Primary outcomes were feasibility of recruitment (the percentage of patients who met study criteria and enrolled) and data collection, appropriateness of treatment (the percent of participants in TOR who score above the midpoint on the Credibility and Expectancy Scale), acceptability (the percentage of patients in TOR who attend at least three of four sessions), and treatment satisfaction (the percent of participants in TOR who score above the midpoint on the Client Satisfaction Scale). Secondary outcomes included additional feasibility (including collecting data on narcotics and rescue medications and adverse events), fidelity (whether the intervention was delivered as planned) and acceptability metrics (patients and staff), pain (numeric rating scale), physical function (Short Musculoskeletal Function Assessment questionnaire [SMFA], PROMIS), emotional function (PTSD [PTSD Checklist], depression [Center for Epidemiologic Study of Depression]), and intervention targets (pain catastrophizing, pain anxiety, coping, and mindfulness). Assessments occurred at baseline, 4 and 12 weeks. Results Several outcomes exceeded a priori benchmarks: feasibility of recruitment (89% [210 of 235] of eligible participants consented), appropriateness (TOR: 73% [66 of 90] scored > midpoint on the Credibility and Expectancy Scale), data collection (79% [154 of 195] completed all surveys), satisfaction (TOR: 99% [75 of 76] > midpoint on the Client Satisfaction Scale), and acceptability (TOR: 73% [71 of 97] attended all four sessions). Participation in TOR, compared with the MEUC, was associated with improvement from baseline to postintervention and from baseline to follow-up in physical function (SMFA, baseline to post: -7 [95% CI -11 to -4]; p < 0.001; baseline to follow-up: -6 [95% CI -11 to -1]; p = 0.02), PROMIS (PROMIS-PF, baseline to follow-up: 2 [95% CI 0 to 4]; p = 0.045), pain at rest (baseline to post: -1.2 [95% CI -1.7 to -0.6]; p < 0.001; baseline to follow-up: -1 [95% CI -1.7 to -0.3]; p = 0.003), activity (baseline to post: -0.7 [95% CI -1.3 to -0.1]; p = 0.03; baseline to follow-up: -0.8 [95% CI -1.6 to -0.1]; p = 0.04), depressive symptoms (baseline to post: -6 [95% CI -9 to -3]; p < 0.001; baseline to follow-up: -5 [95% CI -9 to -2]; p < 0.002), and posttraumatic symptoms (baseline to post: -4 [95% CI -7 to 0]; p = 0.03; baseline to follow-up: -5 [95% CI -9 to -1]; p = 0.01). Improvements were generally clinically important and sustained or continued through the 3 months of follow-up (that is, above the minimum clinically important different [MCID] of 7 for the SMFA, the MCID of 3.6 for PROMIS, the MCID of 2 for pain at rest and pain during activity, the MCID of more than 10% change in depressive symptoms, and the MCID of 10 for posttraumatic symptoms). There were treatment-dependent improvements in pain catastrophizing, pain anxiety, coping, and mindfulness. Conclusion TOR was feasible and potentially efficacious in preventing persistent pain among patients with an acute orthopaedic traumatic injury. Using TOR in clinical practice may prevent persistent pain after orthopaedic traumatic injury. Level of Evidence Level I, therapeutic study.

Objective: Chronic musculoskeletal pain (CMP) is prevalent, burdensome, and associated with an increased risk for opioid use disorder. Evidence suggests that perceived racial/ethnic discrimination is associated with problematic substance use among Black individuals, but studies have not focused on problematic opioid use among Black individuals with CMP specifically or explored the contribution of perceived discrimination, pain intensity, and pain-relevant psychological factors to this association. Method: We recruited 401 Black individuals (M-age = 35.98, 51.9% female) with self-reported CMP and prescription opioid use. We tested whether perceived discrimination (a) was associated with self-reported problematic opioid use and (b) explained unique variance in this outcome after accounting for pain intensity, demographic factors, and psychological factors previously implicated in problematic opioid/substance use (distress tolerance and pain avoidance). Results: Hierarchical linear regression analysis revealed that our model as a whole explained significant variance in problematic opioid use, R-2 = .30, F(6, 394) = 28.66, p < .001. Perceived discrimination specifically was associated with more problematic opioid use (beta = .39, SE = .05, p < .001) and explained unique variance in this outcome even after accounting for pain intensity (beta = .06, SE = .04, p = .20), distress tolerance (beta = -.10, SE = .05, p = .04), pain avoidance (beta = .12, SE = .05, p = .02), age (beta = -.10, SE = .05, p < .05), and employment status (beta = .13, SE = .11, p < .01). Conclusions: Systemic efforts to combat racism along with individualized therapeutic approaches to process and cope with perceived racial discrimination may be particularly important to prevent and reduce problematic opioid use among Black individuals with CMP.

Background Pain is prevalent among adults with neurofibromatoses (NF) and hinders quality of life. Pain management for NF is predominantly pharmacological and often ineffective. Psychosocial treatments improve pain outcomes in other chronic illness populations but have not been developed and tested in fully powered efficacy trials among adults with NF. Using data from a fully powered randomized clinical trial of an 8-week mind-body program (Relaxation Response Resiliency Program for NF [3RP-NF]) versus a health education control (HEP-NF), we examined (1) improvements in pain intensity and pain interference, and (2) mechanisms underlying improvements. Methods Participants (N = 210, M-age = 42.6, 73.4% female) were randomized to 3RP-NF versus HEP-NF. They completed measures of pain intensity, pain interference, and putative mechanisms (eg, mindfulness, coping, and social support) at baseline, post-intervention, 6-month, and 12-month follow-ups. Results There was a statistically significant change in pain interference over time F(3, 537.06) = 7.21, P < .001, but not pain intensity. Neither group (3RP-NF vs. HEP-NF) nor the group-by-time interaction predicted change in pain interference. While the group-by-time interaction was not statistically significant across all time points, planned post-hoc analyses probing the interaction at specific time points revealed a statistically significant decrease in pain interference from baseline to post-intervention (P < .001), which was sustained (ie, no subsequent change) from post-intervention through 6-month (P = 1.00) and 12-month follow-ups (P = 1.00) in the 3RP-NF group. The HEP-NF group had no significant changes in pain intensity or interference over time. The association between group (3RP-NF) and decreased pain interference from baseline to post-intervention was fully mediated by change in coping over the same period. Conclusions Participation in the 3RP-NF is associated with sustained improvement in pain interference. Improvement occurred through increased coping.

PURPOSE/OBJECTIVES:The fear-avoidance model is a well-established framework for understanding the transition from acute to chronic pain. However, its applicability to concussions is not yet well understood. Here, we conduct the first mixed methods analysis of the fear-avoidance model in young adults with a recent concussion and co-occurring anxiety and assess the model's alignment with their lived experience. RESEARCH METHOD/DESIGN:We conducted a mixed methods analysis using a cross-sectional parallel design. Seventeen participants completed questionnaires corresponding with the elements in the fear-avoidance model (e.g., pain catastrophizing, avoidance, disability, anxiety, depression, etc.) and participated in semistructured interviews probing their experiences following their concussion between March 2021 and February 2022. We calculated bivariate correlations for quantitative data and analyzed the qualitative data using hybrid inductive-deductive thematic analysis. RESULTS:Quantitative results demonstrated strong and medium-sized correlations among theorized relationships within the fear-avoidance model (rs = .40-.85) with the majority being statistically significant. Qualitative results provided substantial convergent and complementary support (e.g., bi-directionality of some relationships, associations between nonadjacent model components, centrality of anxiety in symptom persistence) for the application of the fear-avoidance model to concussions. Findings highlighted additional factors (social factors and post-injury endurance patterns) relevant to this population. CONCLUSION/IMPLICATIONS:The fear-avoidance model is a useful lens for understanding the lived experience of young adults with a recent concussion and co-occurring anxiety. Psychosocial treatment for this population would benefit from focusing on the interplay of concussion symptoms, anxiety, depression, disability, and pain-related fear, offering adaptive confrontation strategies, and addressing the interpersonal impact of concussion. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Introduction:Approximately 50% of persons with orthopedic injuries experience psychosocial distress (e.g., depression, anxiety), which can predict chronic pain and disability. Offering psychosocial services in orthopedic settings can promote patient recovery. This study explores health care professionals' perceptions of and recommendations regarding integrated psychosocial care for orthopedic settings.Methods:We conducted 18 semi-structured focus groups with 79 orthopedic health care professionals (e.g., surgeons, residents, nurses) across three Level I Trauma Centers. This secondary data analysis used the evidence-based Rainbow Model of Integrated Care framework to structure hybrid inductive-deductive qualitative data analysis.Results:Orthopedic health care professionals identified potential benefits to psychosocial service integration across all dimensions of integration (i.e., clinical, professional, organizational, system, functional, and normative). These benefits included increased patient satisfaction with care, decreased burden on medical providers to manage patient distress, and decreased healthcare utilization costs. They also identified barriers (e.g., fast-paced clinic flow, mental health stigma) and offered recommendations to address barriers across dimensions of integration.Conclusion:Integrated psychosocial care for orthopedic trauma patients has the potential to improve patient recovery and long-term physical and mental health outcomes. This work identifies strategies to inform the development and implementation of initiatives to integrate psychosocial services within orthopedic settings.

BACKGROUND:Informal caregivers (ie, individuals who provide assistance to a known person with health or functional needs, often unpaid) experience high levels of stress. Caregiver stress is associated with negative outcomes for both caregivers and care recipients. Mindfulness-based interventions (MBIs) show promise for improving stress, emotional distress, and sleep disturbance in caregivers of persons with Alzheimer disease and related dementias (ADRD). Commercially available mobile mindfulness apps can deliver MBIs to caregivers of persons with ADRD in a feasible and cost-effective manner.OBJECTIVE:We are conducting a single-blind feasibility proof-of-concept randomized controlled trial (RCT; National Institutes of Health [NIH] stage 1B) comparing 2 free mobile apps: the active intervention Healthy Minds Program (HMP) with within-app text tailored for addressing stress among caregivers of persons with ADRD, versus Wellness App (WA), a time- and dose-matched educational control also tailored for caregivers of persons with ADRD.METHODS:We aim to recruit 80 geographically diverse and stressed caregivers of persons with ADRD. Interested caregivers use a link or QR code on a recruitment flyer to complete a web-based eligibility screener. Research assistants conduct enrollment phone calls, during which participants provide informed consent digitally. After participants complete baseline surveys, we randomize them to the mindfulness-based intervention (HMP) or educational control podcast app (WA) and instruct them to listen to prescribed content for 10 minutes per day (70 minutes per week) for 12 weeks. Caregivers are blinded to intervention versus control. The study team checks adherence weekly and contacts participants to promote adherence as needed. Participants complete web-based self-report measures at baseline, posttest, and follow-up; weekly process measures are also completed. Primary outcomes are a priori set feasibility benchmarks. Secondary outcomes are stress, emotional distress, sleep disturbance, caregiver burden, mindfulness, awareness, connection, insight, and purpose. We will calculate 1-sided 95% CI to assess feasibility benchmarks. Effect sizes of change in outcomes will be used to examine the proof of concept.RESULTS:Recruitment started on February 20, 2023. We have enrolled 27 caregivers (HMP: n=14; WA: n=13) as of June 2023. Funding began in August 2022, and we plan to finish enrollment by December 2023. Data analysis is expected to begin in May 2024 when all follow-ups are complete; publication of findings will follow.CONCLUSIONS:Through this trial, we aim to establish feasibility benchmarks for HMP and WA, as well as establish a proof of concept that HMP improves stress (primary quantitative outcome), emotional distress, sleep, and mindfulness more than WA. Results will inform a future efficacy trial (NIH stage II). HMP has the potential to be a cost-effective solution to reduce stress in caregivers of persons with ADRD, benefiting caregiver health and quality of care as well as patient care.TRIAL REGISTRATION:ClinicalTrials.gov NCT05732038; https://clinicaltrials.gov/study/NCT05732038.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/50108.

INTRODUCTION Patients admitted to the Neuroscience Intensive Care Unit (Neuro-ICU) with acute neurological illnesses (ANI; e.g., stroke, tumor, TBI) and their informal caregivers experience high rates of anxiety, depression, and posttraumatic stress. To address this need, we previously developed the Recovering Together (RT) dyadic intervention to help prevent chronic emotional distress in both patients and caregivers. Currently, we are conducting a fully-powered, single-blind randomized clinical trial (RCT) to evaluate the efficacy of RT versus an attention matched health education control. Here, we describe the protocol and current status of this RCT. METHODS We aim to recruit 194 at risk patient-caregiver dyads from the Neuro-ICU at MGH. Eligible dyads include patients diagnosed with ANI, cognitively intact, at least one partner endorses emotional distress (on Hospital Anxiety and Depression Scale), English speaking, age 18 or older. Dyads are randomized to the intervention (RT-1) or control condition (RT-2) (both six-sessions). RT-1 teaches resiliency (e.g., coping, mindfulness) and interpersonal skills. RT-2 provides education on health-related topics (e.g., stress, self-care, adhering to medical recommendations). Blinded research assistants collect measures at baseline, post-intervention, and three months follow-up. We will conduct mixed linear, mediation, and actor-partner interdependence models to examine changes in dyads' outcomes across time. RESULTS We have recruited 28 dyads and aim to recruit 194 total. DISCUSSION If successful, we plan to test RT in a large-scale, multisite hybrid effectiveness-implementation study in Neuro-ICUs across the country. Enhancing psychosocial supports for patients and families could improve health outcomes, healthcare efficiency, and the culture of these units.

INTRODUCTION:Patients admitted to the Neuroscience Intensive Care Unit (Neuro-ICU) with acute neurological illnesses (ANI; e.g., stroke, tumor, TBI) and their informal caregivers experience high rates of anxiety, depression, and posttraumatic stress. To address this need, we previously developed the Recovering Together (RT) dyadic intervention to help prevent chronic emotional distress in both patients and caregivers. Currently, we are conducting a fully-powered, single-blind randomized clinical trial (RCT) to evaluate the efficacy of RT versus an attention matched health education control. Here, we describe the protocol and current status of this RCT. METHODS:We aim to recruit 194 at risk patient-caregiver dyads from the Neuro-ICU at MGH. Eligible dyads include patients diagnosed with ANI, cognitively intact, at least one partner endorses emotional distress (on Hospital Anxiety and Depression Scale), English speaking, age 18 or older. Dyads are randomized to the intervention (RT-1) or control condition (RT-2) (both six sessions). RT-1 teaches resiliency (e.g., coping, mindfulness) and interpersonal skills. RT-2 provides education on health-related topics (e.g., stress, self-care, adhering to medical recommendations). Blinded research assistants collect measures at baseline, post-intervention, and three months follow-up. We will conduct mixed linear, mediation, and actor-partner interdependence models to examine changes in dyads' outcomes across time. RESULTS:We have recruited 41 dyads and aim to recruit 194 total. DISCUSSION:If successful, we plan to test RT in a large-scale, multisite hybrid effectiveness-implementation study in Neuro-ICUs across the country. Enhancing psychosocial supports for patients and families could improve health outcomes, healthcare efficiency, and the culture of these units.