A Brief Mind-body Intervention Is Feasible and May Prevent Persistent Pain After Acute Orthopaedic Traumas: A Randomized Controlled Trial.

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.

"I completely shut down": A mixed methods evaluation of the fear-avoidance model for young adults with a recent concussion and anxiety.

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).

Integrating Psychosocial Care into Orthopedic Settings: A Qualitative Study of Provider Perspectives.

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.

Perceived discrimination and problematic opioid use among Black individuals with chronic musculoskeletal pain.

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 (Mage = 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, R² = .30, F(6, 394) = 28.66, p < .001. Perceived discrimination specifically was associated with more problematic opioid use (ß = .39, SE = .05, p < .001) and explained unique variance in this outcome even after accounting for pain intensity (ß = .06, SE = .04, p = .20), distress tolerance (ß = -.10, SE = .05, p = .04), pain avoidance (ß = .12, SE = .05, p = .02), age (ß = -.10, SE = .05, p < .05), and employment status (ß = .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. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Mindfulness-Based App to Reduce Stress in Caregivers of Persons With Alzheimer Disease and Related Dementias: Protocol for a Single-Blind Feasibility Proof-of-Concept Randomized Controlled Trial.

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.

How Do Orthopaedic Providers Conceptualize Good Patient Outcomes and Their Barriers and Facilitators After Acute Injury? A Qualitative Study.

BACKGROUND: Good clinical outcomes in orthopaedics are largely dictated by the biomedical model, despite mounting evidence of the role of psychosocial factors. Understanding orthopaedic providers' conceptualizations of good clinical outcomes and what facilitates and hinders them may highlight critical barriers and opportunities for training providers on biopsychosocial models of care and integrating them into practice. QUESTIONS/PURPOSES: (1) How do orthopaedic trauma healthcare providers define good clinical outcomes for their patients after an acute orthopaedic injury? (2) What do providers perceive as barriers to good outcomes? (3) What do providers perceive as facilitators of good outcomes? For each question, we explored providers' responses in a biopsychosocial framework. METHODS: In this cross-sectional, qualitative study, we recruited 94 orthopaedic providers via an electronic screening survey from three Level I trauma centers in geographically diverse regions of the United States (rural southeastern, urban southwestern, and urban northeastern). This study was part of the first phase of a multisite trial testing the implementation of a behavioral intervention to prevent chronic pain after acute orthopaedic injury. Of the 94 participants who were recruited, 88 completed the screening questionnaire. Of the 88 who completed it, nine could not participate because of scheduling conflicts. Thus, the final sample included 79 participants: 48 surgeons (20 attendings, 28 residents; 6% [three of 48] were women, 94% [45 of 48] were between 25 and 55 years old, 73% [35 of 48] were White, and 2% [one of 48] were Hispanic) and 31 other orthopaedic professionals (10 nurse practitioners, registered nurses, and physician assistants; 13 medical assistants; five physical therapists and social workers; and three research fellows; 68% [21 of 31] were women, 97% [30 of 31] were between 25 and 55 years old, 71% [22 of 31] were White, and 39% [12 of 31] were Hispanic). Using a semistructured interview, our team of psychology researchers conducted focus groups, organized by provider type at each site, followed by individual exit interviews (5- to 10-minute debriefing conversations and opportunities to voice additional opinions one-on-one with a focus group facilitator). In each focus group, providers were asked to share their perceptions of what constitutes a "good outcome for your patients," what factors facilitate these outcomes, and what factors are barriers to achieving those outcomes. Focus groups were approximately 60 minutes long. A research assistant recorded field notes during the focus groups to summarize insights gained and disseminate findings to the broader research team. Using this procedure, we determined that thematic saturation was reached for all topics and no additional focus groups were necessary. Three independent coders identified the codes of good outcomes, outcome barriers, and outcome facilitators and applied this coding framework to all transcripts. Three separate data interpreters collaboratively extracted themes related to biomedical, psychological, and social factors and corresponding inductive subthemes. RESULTS: Although orthopaedic providers' definitions of good outcomes naturally included biomedical factors (bone healing, functional independence, and pain alleviation), they were also marked by nuanced psychosocial factors, including the need for patients to recover from psychological trauma associated with injury and feel heard and understood-not just as outcome facilitators, but also as key outcomes themselves. Regarding perceived barriers to good outcomes, providers interwove psychological and biomedical factors (for example, "if they're a smoker, if they have depression, anxiety…") and discussed how psychological dysfunction (for example, maladaptive avoidance or fear of reinjury) can limit key behaviors during recovery (such as adherence to physical therapy regimens). Unprimed, providers also cited resiliency-related terms from psychological research, including (low) "self-efficacy," "catastrophic thinking," and (lack of) psychological "hardiness" as barriers. Regarding perceived facilitators of good outcomes, various social and socioeconomic factors emerged, including a biosocial connection between recovery, social support, and "privilege" (such as occupation or education). These perspectives emerged across sites and provider types. CONCLUSION: Although the biomedical model prevails in clinical practice, providers across all sites, in various roles, defined good outcomes and their barriers and facilitators in terms of interconnected biopsychosocial factors without direct priming to do so. Thus, similar Level I trauma centers may be more ready to adopt biopsychosocial care approaches than initially expected. CLINICAL RELEVANCE: Providers' perspectives in this study aligned with a growing body of research on the role of biomedical and psychosocial factors in surgical outcomes and risk of transition to chronic pain. To translate these affirming attitudes into practice, other Level I trauma centers could encourage leaders who adopt biopsychosocial approaches to share their perspectives and train other providers in biopsychosocial conceptualization and treatment.

The Recovering Together study protocol: A single-blind RCT to prevent chronic emotional distress in patient-cargiver dyads in the Neuro-ICU.

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.