Mental health, pain and likelihood of opioid misuse among adults with sickle cell disease.

Depressive symptoms are prevalent in individuals living with sickle cell disease (SCD) and may exacerbate pain. This study examines whether higher depressive symptoms are associated with pain outcomes, pain catastrophizing, interference and potential opioid misuse in a large cohort of adults with SCD. The study utilized baseline data from the 'CaRISMA' trial, which involved 357 SCD adults with chronic pain. Baseline assessments included pain intensity, daily mood, the Patient Health Questionnaire (PHQ), the Generalized Anxiety Disorders scale, PROMIS Pain Interference, Pain Catastrophizing Scale, the Adult Sickle Cell Quality of Life Measurement Information System and the Current Opioid Misuse Measure. Participants were categorized into 'high' or 'low' depression groups based on PHQ scores. Higher depressive symptoms were significantly associated with increased daily pain intensity, negative daily mood, higher pain interference and catastrophizing, poorer quality of life and a higher likelihood of opioid misuse (all p < 0.01). SCD patients with more severe depressive symptoms experienced poorer pain outcomes, lower quality of life and increased risk of opioid misuse. Longitudinal data from this trial will determine whether addressing depressive symptoms may potentially reduce pain frequency and severity in SCD.

Association between trauma triage and time-to-vaso-occlusive events in patients with sickle cell disease after traumatic injury: a retrospective study.

Introduction: Sickle cell disease (SCD) is associated with vaso-occlusive events (VOEs) that can lead to disease complications, including early mortality. Given that similar inflammatory responses characterize VOE and traumatic injury, injured patients with SCD may be vulnerable to acute complications. This study is the first to examine whether traumatic injury is associated with increased severity of future VOEs. Methods: This cohort study was conducted using electronic health record data from an SCD clinic in Western Pennsylvania; 356 patients with SCD from January 2000 to July 2021 were identified via retrospective chart review. 55 patients were eligible based on continuous medical record data spanning 1 year preinjury and postinjury. Patients were sorted into three treatment groups based on injury management: (1) Neither triage to trauma team activation (TTA) nor inpatient admission (Early Discharge), (2) Triage but no inpatient admission (Triage Only), and (3) Triage and In-patient. Outcomes included time from injury to first VOE, annual VOE counts requiring an emergency department (ED) visit, and ED length of stay (LOS) for the first VOE after injury. Results: Early Discharge individuals experienced a VOE event within 2.93 days of injury, significantly shorter time to event than Triage and In-patient individuals at 52.375 days and Triage Only individuals at 100.16 days (p=0.0058). No difference in annual VOE counts was noted postinjury across all groups. However, a significant increase in VOE LOS preinjury (16.1 hours) to postinjury (77.4 hours) was noted only for the Triage Only group (p=0.038). Cox regression model showed that shortened time to VOE events was marginally associated with TTA status (p=0.06). Conclusion: Despite minimal changes in long-term VOE outcomes after injury, traumatic injuries may accelerate the time-to-VOE among the Early Discharge group. Therefore, future research is warranted to analyze whether the absence of postinjury triage assessment and intervention may cause unforeseen physiologic stressors contributing to VOE outcomes. Level of evidence: Level IV: retrospective case-control study with three negative criteria.

Use of Disease-Modifying Treatments in Patients With Sickle Cell Disease.

Importance: Despite hydroxyurea being an established treatment for sickle cell disease (SCD), it remains underused. The recent approval of the disease-modifying treatments (DMTs) l-glutamine, crizanlizumab, and voxelotor underscores the need to understand the uptake of DMTs in the current treatment landscape. Objective: To explore characteristics that may be associated with DMT use and to describe observed patterns of yearly DMT use from 2014 to 2021. Design, Setting, and Participants: This cross-sectional study used administrative claims data from Optum's deidentified Clinformatics Data Mart Database from January 1, 2014, to September 30, 2021, to identify adults and children with SCD. Data were analyzed from August 1, 2022, to August 28, 2023. Exposure: Use of DMTs. Main Outcomes and Measures: Patient characteristics across groups with varying patterns of DMT use and yearly patterns of prescription fills for hydroxyurea, crizanlizumab, voxelotor, and l-glutamine. Results: A total of 5022 beneficiaries with SCD (2081 [41.4%] aged 18-45 years; 2929 [58.3%] female) were included in sample A (144 [2.9%] inconsistent users, 274 [5.5%] incident users, 892 [17.8%] consistent users, and 3712 [73.9%] non-DMT users). Inconsistent users had a higher prevalence of vaso-occlusive crises (mean [SD], 3.7 [4.7]), splenic complications (6 of 144 [4.2%]), pulmonary complications (36 of 144 [25.0%]), kidney disease (21 of 144 [14.6%]), acute chest syndrome (18 of 144 [12.5%]), and health care visits (eg, mean [SD] inpatient visits, 7.0 [10.7]) compared with the other use groups. Non-DMT users had the lowest prevalence of vaso-occlusive crises (mean [SD], 0.8 [2.4]), acute chest syndrome (109 of 3712 [2.9%]), and inpatient (mean [SD], 2.0 [6.6]) and emergency department (mean [SD], 0.7 [3.1]) visits and the highest proportion of adults 65 years and older (593 of 3712 [16.0%]). In sample B (6387 beneficiaries with SCD), hydroxyurea use modestly increased from 428 of 2188 participants (19.6%) in 2014 to 701 of 2880 (24.3%) in 2021. Use of l-glutamine increased briefly but gradually decreased throughout the study period. In 2021, out of 2880 participants, 102 (3.5%) had at least 1 fill for crizanlizumab and 131 (4.6%) had at least 1 fill for voxelotor. Overall, total DMT use increased from 428 of 2188 participants (19.6%) in 2014 to 815 of 2880 patients (28.3%) in 2021. Conclusions and Relevance: In this cross-sectional analysis of adults and children with SCD, uptake of DMTs remained low from 2014 to 2021, despite the approval of newer therapies. Notable differences in patient characteristics across varied DMT exposure types necessitate further exploration into factors that facilitate DMT use and the creation of strategies to enhance DMT uptake.

Utilizing Television Clips for Graduate Medical Education Anti-racist Curricula: An Acceptability Study.

Introduction Racism is a pervasive social problem that influences medicine, highlighting the need for interventions. One promising educational technique, referred to as edutainment, utilizes clips from television shows as an instructive strategy. The objective of this study was to examine the acceptability of edutainment around anti-racist curricula for residents. Methods We conducted a survey of underrepresented in medicine (URM) medical faculty to inform content for subsequent focus groups with medicine, psychiatry, and pediatrics residents. For the survey, URM faculty were randomly assigned to view four of eight clips and responded to close- and open-ended items. Focus group participants viewed selected clips and provided feedback. All study procedures occurred in 2020-2021. We calculated descriptive statistics for close-ended survey items and employed thematic analysis for open-ended items and focus group transcripts. Results Twelve URM faculty completed the survey. Feedback was uniformly positive so we included all eight clips in the resident focus groups. For each of the three participating specialties, we conducted two focus groups (2-11 participants each, total n=25) with participants viewing four of the eight clips. Analysis of focus group transcripts found that participants were receptive to the edutainment approach. Feedback as to the realism and acceptability of certain clips differed by specialty. Triangulation of survey and focus group results found differences in the acceptability of specific clips between residents and faculty. Conclusion Edutainment with medical television shows may be a promising avenue for anti-racist curricular content for residents. The educational methods described here are being incorporated into a multi-pronged, hospital system wide graduate medical education anti-racist curriculum.

The Effect of an Adapted Digital Mental Health Intervention for Sickle Cell Disease on Engagement: A Pilot Randomized Controlled Trial.

INTRODUCTION: Despite promising outcomes, lack of engagement and poor adherence are barriers to treating mental health using digital CBT, particularly in minority groups. After conducting guided focus groups, a current mental health app was adapted to be more inclusive for minorities living with SCD. METHODS: Patients between the ages of 16-35 with SCD who reported experiencing anxiety or depression symptoms were eligible for this study. Once enrolled, participants were randomly assigned to receive one of two versions of a mental health app 1) the current version designed for the general population and 2) the adapted version. Baseline measures for depression, anxiety, pain and self-efficacy were completed at the start of the study and again at postintervention (minimum 4 weeks). RESULTS: Compared to baseline, pain (p = 0.03), self-efficacy (p = 0.007) and depression symptoms (p = 0.016) improved for the group that received the adapted app. Regardless of group assignment, a positive relationship (r = 0.47) was shown between app engagement and a change in depression symptoms (p = 0.042). DISCUSSION: Target enrollment for this study sought to enroll 40 participants. However, after difficulties locating qualified participants, enrollment criteria were adjusted to expand the population pool. Regardless of these efforts, the sample size for this study was still smaller than anticipated (n = 21). Additionally, irrespective of group approximately 40% of participants did not engage with the app. However, despite a small sample size and poor engagement, participants in the intervention group displayed better outcomes and showed trends for greater app interaction. CONCLUSION: These promising results should encourage future researchers to continue exploring ideal adaptations for implementing digital CBT in minority populations. Future studies should also consider implementing post-intervention surveys to help identify common factors relating to a lack of engagement.

Tailoring a Digital Mental Health Program for Patients With Sickle Cell Disease: Qualitative Study.

BACKGROUND: Depression and other mental health disorders are prevalent among people living with chronic health conditions. Although digital cognitive behavioral therapy (CBT) is considered an effective treatment, African American individuals are less likely to engage in and adhere to digital therapies for mental health disorders compared with White individuals. OBJECTIVE: The aim of this study was to understand digital CBT mental health treatment perceptions and preferences of African American individuals with sickle cell disease (SCD). METHODS: African American individuals with SCD from various US locations were invited to participate in a series of focus groups. Participants were introduced to a health coach-supported mental health app and then asked a series of questions about the usability and appeal of the program as well as, more generally, what would make a digital mental health program effective for them. The authors reviewed the focus group transcripts and conducted a qualitative analysis of the results. RESULTS: A total of 25 people participated in 5 focus groups. Overall, 5 primary themes emerged regarding how app content and related coaching could be modified to enhance digital CBT engagement. These themes included connection with others living with SCD, the personalization of app content and coaching, characteristics of coaches, journaling and pain tracking, and considerations for optimal engagement. CONCLUSIONS: Enhancing the user experience by making digital CBT tools relevant to patient populations is critical for optimizing program engagement and its uptake. Our findings highlight potential strategies to modify and design digital CBT tools for users with SCD and may also be applicable to patients with other chronic conditions. TRIAL REGISTRATION: ClinicalTrials.gov NCT04587661; https://clinicaltrials.gov/ct2/show/NCT04587661.

Scheduled and attended pediatric primary care telemedicine appointments during COVID-19.

BACKGROUND: The aim of this study was to examine pediatric primary care telemedicine visit scheduling and attendance during the first year of telemedicine. METHODS: Using electronic health record data from two academic pediatric primary care practices between April 2020-March 2021, we used Pearson χ2 tests and logistic regression models to identify child-, family-, and appointment-level characteristics associated with scheduled and attended telemedicine appointments. RESULTS: Among 5178 primary care telemedicine appointments scheduled during the 12-month period, the proportion of appointments scheduled differed over time for children in families with a language preference other than English or Spanish (4% quarter 1 vs. 6% in quarter 4, p = 0.01) and residing in ZIP codes with the lowest household technology access (24% in quarter 1 vs. 19% in quarter 3 (p = 0.01). Four thousand one hundred and forty-eight of 5178 scheduled telemedicine appointments were attended. Likelihood of attending a telemedicine appointment was highest for children in families with a language preference other than English or Spanish (90%, 95% CI 86-94% compared to Spanish 74%, 95% CI 65-84%), and same-day appointments (86%, 95% CI 85-87%). Attendance among families preferring Spanish language was higher in later months compared to earlier months. CONCLUSIONS: We found disparities in scheduling and attending telemedicine appointments, but signs of greater language equity over time.

Prevalence of Substance Use Disorders in Sickle Cell Disease Compared to Other Chronic Conditions: a Population-Based Study of Black American Adults.

BACKGROUND: Sickle cell disease (SCD) is a heritable chronic health condition characterized by pain symptoms throughout the life course that are routinely treated with opioids. OBJECTIVE: This study examined differences in substance use disorders in Black American adults with SCD compared to those with other chronic conditions or with no chronic conditions. DESIGN: Data from a population-representative sample of Black Americans with SCD, other chronic conditions, and no chronic conditions were obtained from the National Survey of American Life (NSAL) database. Diagnosis of substance use disorder was determined by structured clinical interview. Hierarchical models controlling for covariates (demographics, socioeconomic status, self-rated health, and mood disorders) compared odds of diagnosis between the three groups. PARTICIPANTS: The sample included 4238 African-American and Black Caribbean participants from the NSAL study who were 18 years of age or older. MAIN MEASURES: Measures included age, sex, income, education, marital status, employment, possession of health insurance, health conditions, and substance use disorders diagnosed by structured clinical interview. KEY RESULTS: Controlling for age, sex, and socioeconomic status, there were no differences in odds of a drug use disorder when comparing individuals with SCD to Black adults with other chronic conditions (OR = 1.12; p = 0.804) or no chronic condition (OR = 2.09; p = 0.102). SCD was, however, associated with greater odds of alcohol use disorders when compared to the groups with other chronic conditions (OR = 2.15; p = 0.01) and no chronic conditions (OR = 5.11; p < 0.001). This effect was not better accounted for by socioeconomic status, marital status, self-rated physical health, or the presence of a mood disorder. CONCLUSIONS: SCD was not a risk factor for drug use disorders. Further data will be needed to understand the factors contributing to increased risk of alcohol use disorders in SCD and the role uncontrolled pain symptoms may have in driving substance use.

A protocol for applying health equity-informed implementation science models and frameworks to adapt a sleep intervention for adolescents at risk for suicidal thoughts and behaviors.

Background: Effective and equitable strategies to prevent youth suicidal thoughts and behaviors (STB) are an urgent public health priority. Adolescent sleep disturbances are robustly linked to STB but are rarely addressed in preventive interventions or among Black and/or Hispanic/Latinx youth for whom STB risk is increasing disproportionately. This paper describes an application of health equity-informed implementation science models and frameworks to adapt and evaluate the evidence-based Transdiagnostic Sleep and Circadian (TSC) intervention for primary care implementation with adolescents of minoritized backgrounds with depression and STB risk. Methods: This multiphase study protocol uses the Assessment, Decision, Adaptation, Production, Topical Experts-Integration, Training, Testing (ADAPT-ITT) model to adapt and evaluate TSC for primary care implementation with adolescents who are depressed, at risk for STB, and of primarily Black and/or Hispanic/Latinx backgrounds. We integrate the Consolidated Framework for Implementation Research (CFIR) in an initial qualitative inquiry of adolescent, caregiver, and clinician perceptions of TSC. Subsequent ADAPT-ITT phases include systematically and iteratively testing adaptations based on the qualitative inquiry, with ongoing key informant input, and then evaluating the adapted TSC for feasibility, acceptability, and efficacy in a pilot randomized trial. Anticipated results: Based on youth depression and sleep health disparities research, we expect that TSC adaptations will be needed to enhance intervention content for adolescents with depression, STB risk, and primarily Black and/or Hispanic/Latinx backgrounds. We also anticipate adaptations will be needed to align TSC delivery methods with primary care implementation. Conclusions: Adapting evidence-based interventions with end-users and contexts in mind can help ensure that intervention strategies and delivery methods are acceptable to, and feasible with, health disparate populations. Although TSC has shown effectiveness for adolescents with sleep disturbances, we expect that additional multiphase research is necessary to optimize TSC for primary care delivery with Black and/or Hispanic/Latinx adolescents with depression and STB risk.

Getting To Implementation (GTI)-Teach: A seven-step approach for teaching the fundamentals of implementation science.

Introduction: Implementation Science (IS) is a complex and rapidly evolving discipline, posing challenges for educators. We developed, implemented, and evaluated a novel, pragmatic approach to teach IS. Methods: Getting To Implementation (GTI)-Teach was developed as a seven-step educational model to guide students through the process of developing, conducting, and sustaining an IS research project. During the four-week online course, students applied the steps to self-selected implementation problems. Students were invited to complete two online post-course surveys to assess course satisfaction and self-reported changes in IS knowledge and relevance of GTI-Teach Steps to their work. Results were summarized using descriptive statistics; self-reported post-course changes in IS knowledge were compared using paired t-tests. Results: GTI-Teach was developed to include seven Steps: 1. Define the implementation problem; 2. Conceptualize the problem; 3. Prioritize implementation barriers and facilitators; 4. Select and tailor implementation strategies; 5. Design an implementation study; 6. Evaluate implementation; 7. Sustain implementation. Thirteen students, ranging in experience from medical students to full professors, enrolled in and completed the first GTI-Teach course. Of the seven students (54%) completing an end-of course survey, six (86%) were very satisfied with the course. Ten students (77%) responded to the tailored, 6-month post-course follow-up survey. They retrospectively reported a significant increase in their knowledge across all steps of GTI-Teach (1.3-1.8 points on a 5-point Likert scale) and rated each of the Steps as highly relevant to their work. Conclusions: GTI-Teach is a seven-step model for teaching IS fundamentals that students reported increased their knowledge and was relevant to their work.

A case-control and seven-year longitudinal neurocognitive study of adults with sickle cell disease in Ghana.

Ageing in sickle cell disease (SCD) is associated with a myriad of end-organ complications, including cerebrovascular damage and cognitive impairment (CI). Although CI is very common in SCD, little is known about cognitive functioning and how it changes with age. This study examines cognitive patterns of 63 adults with SCD and 60 non-SCD, age- and education-matched controls in Ghana. Of those adults with SCD, 34 completed the neuropsychological battery at baseline and again seven years later. In cross-sectional data, adults with SCD performed worse than controls in all cognitive test domains (p < 0.01 for all). The seven-year follow-up data showed that the group exhibited a significant decline in visuospatial abilities (ranging from Cohen's d = 1.40 to 2.38), and to a lesser extent, in processing speed and executive functioning. Exploratory analyses showed a significant time-by-education interaction, indicating that education may be protective from decline in cognitive performance. These findings have implications for clinical practice. Early neuropsychological surveillance coupled with early assessment and remedial programmes will provide avenues for enhancing the quality of life of adults living with SCD in Ghana.

A Novel Method for Digital Pain Assessment Using Abstract Animations: Human-Centered Design Approach.

BACKGROUND: Patients with chronic pain face several challenges in using clinical tools to help them monitor, understand, and make meaningful decisions about their pain conditions. Our group previously presented data on Painimation, a novel electronic tool for communicating and assessing pain. OBJECTIVE: This paper describes the human-centered design and development approach (inspiration, ideation, and implementation) that led to the creation of Painimation. METHODS: We planned an iterative and cyclical development process that included stakeholder engagement and feedback from users. Stakeholders included patients with acute and chronic pain, health care providers, and design students. Target users were adults with acute or chronic pain who needed clinical assessment and tracking of the course of their pain over time. Phase I (inspiration) consisted of empathizing with users, understanding how patients experience pain, and identifying the barriers to accurately expressing and assessing pain. This phase involved understanding how patients communicate pain symptoms to providers, as well as defining limitations of current models of clinical pain assessment tools. In Phase II (ideate) we conceptualized and evaluated different approaches to expressing and assessing pain. The most promising concept was developed through an iterative process that involved end users and stakeholders. In Phase III (implementation), based on stakeholder feedback from initial designs and prototypes of abstract pain animations (painimations), we incorporated all concepts to test a minimally viable product, a fully functioning pain assessment app. We then gathered feedback through an agile development process and applied this feedback to finalizing a testable version of the app that could ultimately be used in a pain clinic. RESULTS: Engaging intended users and stakeholders in an iterative, human-centered design process identified 5 criteria that a pain assessment tool would need to meet to be effective in the medical setting. These criteria were used as guiding design principles to generate a series of pain assessment concept ideas. This human-centered approach generated 8 highly visual painimations that were found to be acceptable and useable for communicating pain with medical providers, by both patients with general pain and patients with sickle cell disease (SCD). While these initial steps continued refinement of the tool, further data are needed. Agile development will allow us to continue to incorporate precision medicine tools that are validated in the clinical research arena. CONCLUSIONS: A multiphase, human-centered design approach successfully resulted in the development of an innovation that has potential to improve the quality of medical care, particularly for underserved populations. The use of Painimation may especially benefit the medical care of minority populations with chronic and difficult-to-treat pain, such as adults with SCD. The insights generated from this study can be applied to the development of patient-reported outcomes tools that are more patient-centered, engaging, and effective.

Differences in the prevalence of mental health disorders among Black American adults with sickle cell disease compared to those with non-heritable medical conditions or no medical conditions.

Our aim was to determine differences in the prevalence of mental health disorders between Black Americans living with sickle cell disease (SCD) and Black Americans with other, non-heritable medical conditions, or no medical conditions. We examined the prevalence of mental health disorders among a non-institutionalized, community sample of Black adults in the US from the National Survey of American Life. We compared the odds of mental health disorders between Black American adults with SCD and those with other medical conditions, or no medical condition. Among the SCD group, 38·8% reported at least one mental health disorder: 17·6% endorsed a mood disorder, 24·7% an anxiety disorder, 2·4% an eating disorder, and 11·8% a childhood disorder. Compared to those with other medical conditions, Black Americans with SCD had greater poverty, more children in the household, and were less likely to be married/cohabitating (all P < 0·05). Yet, Black Americans with SCD were not at greater odds of having a mental health disorder compared to those with other medical conditions. When compared to the group with no conditions, however, individuals with SCD had 2·57 greater odds of mood disorder (95% confidence interval: 1·43-4·65; P = 0·002). The effect remained when controlling for socioeconomic status, marital status, and perceived physical health. In this study, almost 40% of Black American adults with SCD presented with a mental health disorder. Prevalence of mental health disorders was similar among those with non-heritable medical conditions, but those without a medical condition had a lower prevalence than in SCD. Among Black Americans, there appear to be unmeasured factors, common across medical conditions, that are linked to mental health disorders.

The Impact of Optimism and Pain Interference on Response to Online Behavioral Treatment for Mood and Anxiety Symptoms.

OBJECTIVE: This study aimed to explore a) if high pain interference has a negative effect on response to computerized cognitive behavioral therapy (cCBT) for anxiety and depression and b) whether high optimism can buffer the negative effects of pain interference on cCBT outcomes. METHODS: We performed a secondary analysis of data on 403 participants from the randomized controlled clinical trial "Online Treatment for Mood and Anxiety Disorders in Primary Care." It examined the impact of cCBT, with and without access to an Internet support group, on health-related quality of life (HRQoL), mood, and anxiety symptoms. RESULTS: High versus low pain interference had a negative effect on response to cCBT for physical HRQoL regardless of high or low optimism level (between group difference = -3.46 [-5.89 to -1.03], p = .005, or -4.06 [-6.28 to -1.85], p < .001, respectively). However, in the context of low optimism/high pain interference only negatively impacted the effect of cCBT on mental HRQoL (3.68 [0.63 to 6.73], p = .018) and anxiety symptoms (-2.61 [-4.87 to -0.35], p = .024). Although the pattern of effects was similar for depressive symptoms, the between-group differences were not significant. CONCLUSIONS: High optimism may buffer against the negative effects of pain interference on treatment response from cCBT. Primary care patients who report high pain interference yet also lack optimism may not receive as much benefit from cCBT as other groups. Furthermore, this study found an unexpected positive effect of low optimism on treatment response. For depressed and anxious patients with low pain interference, low optimism enhanced the impact of cCBT on mental HRQoL.Trial Registration:ClinicalTrials.gov Identifier: NCT01482806.

Racial Diversity Among American Cardiologists: Implications for the Past, Present, and Future.

In the United States, race-based disparities in cardiovascular disease care have proven to be pervasive, deadly, and expensive. African American/Black, Hispanic/Latinx, and Native/Indigenous American individuals are at an increased risk of cardiovascular disease and are less likely to receive high-quality, evidence-based medical care as compared with their White American counterparts. Although the United States population is diverse, the cardiovascular workforce that provides its much-needed care lacks diversity. The available data show that care provided by physicians from racially diverse backgrounds is associated with better quality, both for minoritized patients and for majority patients. Not only is cardiovascular workforce diversity associated with improvements in health care quality, but racial diversity among academic teams and research scientists is linked with research quality. We outline documented barriers to achieving workforce diversity and suggest evidence-based strategies to overcome these barriers. Key strategies to enhance racial diversity in cardiology include improving recruitment and retention of racially diverse members of the cardiology workforce and focusing on cardiovascular health equity for patients. This review draws attention to academic institutions, but the implications should be considered relevant for nonacademic and community settings as well.

Comparing the Effectiveness of Education Versus Digital Cognitive Behavioral Therapy for Adults With Sickle Cell Disease: Protocol for the Cognitive Behavioral Therapy and Real-time Pain Management Intervention for Sickle Cell via Mobile Applications (CaRISMA) Study.

BACKGROUND: Patients with sickle cell disease (SCD) experience significant medical and psychological stressors that affect their mental health, well-being, and disease outcomes. Digital cognitive behavioral therapy (CBT) has been used in other patient populations and has demonstrated clinical benefits. Although evidence-based, nonpharmacological interventions for pain management are widely used in other populations, these treatments have not been well studied in SCD. Currently, there are no adequately powered large-scale clinical trials to evaluate the effectiveness and dissemination potential of behavioral pain management for adults with SCD. Furthermore, some important details regarding behavioral therapies in SCD remain unclear-in particular, what works best for whom and when. OBJECTIVE: Our primary goal is to compare the effectiveness of two smartphone-delivered programs for reducing SCD pain symptoms: digital CBT versus pain and SCD education (Education). Our secondary goal is to assess whether baseline depression symptoms moderate the effect of interventions on pain outcomes. We hypothesize that digital CBT will confer greater benefits on pain outcomes and depressive symptoms at 6 months and a greater reduction in health care use (eg, opioid prescriptions or refills or acute care visits) over 12 months. METHODS: The CaRISMA (Cognitive Behavioral Therapy and Real-time Pain Management Intervention for Sickle Cell via Mobile Applications) study is a multisite comparative effectiveness trial funded by the Patient-Centered Outcomes Research Institute. CaRISMA is conducted at six clinical academic sites, in partnership with four community-based organizations. CaRISMA will evaluate the effectiveness of two 12-week health coach-supported digital health programs with a total of 350 participants in two groups: CBT (n=175) and Education (n=175). Participants will complete a series of questionnaires at baseline and at 3, 6, and 12 months. The primary outcome will be the change in pain interference between the study arms. We will also evaluate changes in pain intensity, depressive symptoms, other patient-reported outcomes, and health care use as secondary outcomes. We have 80% power to detect a difference of 0.37 SDs between study arms on 6-month changes in the outcomes with 15% expected attrition at 6 months. An exploratory analysis will examine whether baseline depression symptoms moderate the effect of the intervention on pain interference. RESULTS: This study will be conducted from March 2021 through February 2022, with results expected to be available in February 2023. CONCLUSIONS: Patients with SCD experience significant disease burden, psychosocial stress, and impairment of their quality of life. CaRISMA proposes to leverage digital technology and overcome barriers to the routine use of behavioral treatments for pain and depressive symptoms in the treatment of adults with SCD. The study will provide data on the comparative effectiveness of digital CBT and Education approaches and evaluate the potential for implementing evidence-based behavioral interventions to manage SCD pain. TRIAL REGISTRATION: ClinicalTrials.gov NCT04419168; https://clinicaltrials.gov/ct2/show/NCT04419168. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/29014.

Correction to: Low Life Course Socioeconomic Status (SES) Is Associated with Negative NEO PI-R Personality Patterns.

After the publication of the original article, the Editor was notified by Duke University that they have determined the authorship to be incomplete. Consequently, Dr Edward Suarez has been added as a co-author to represent his contribution to the conception and design of the work and acquisition of the data.

Society of Behavioral Medicine (SBM) urges Congress to ensure efforts to increase and enhance broadband internet access in rural areas.

The Society for Behavioral Medicine (SBM) recommends expanding access to high-speed, high-definition internet and increasing broadband width for rural communities in the USA to increase telehealth opportunities for populations facing geographic barriers to accessing quality healthcare. High-speed telehealth will allow healthcare providers to care for patients in "real time" and will expand access to specialty providers thereby increasing timely follow-up, improving health outcomes, and reducing rural health disparities. Moreover, SBM recommends that the current National Broadband Plan legislation be protected and enhanced to ensure high-quality, but also affordable, internet services in rural areas. Several legislative bills have been put forth but are not fully funded or enacted by individual states. In addition, further mechanisms and supplemental funding are needed to address the continued lack of resources to enhance rural broadband including infrastructure, research, and regulatory reform.