Background and Purpose: The aim of the study was to examine the psychometric properties of the Sickle Cell Self-Efficacy Scale (SCSES) in an anonymous, online cohort of adults with sickle cell disease (SCD). Methods: The SCSES was completed by 60 adults with SCD. An exploratory factor analysis was conducted. Convergent validity and discriminant validity were assessed using bivariate correlations between the SCSES and other study variables, and internal consistency reliability was evaluated through examining an alpha coefficient. Results: A unidimensional factor structure explained 49.6% of the variance in self-efficacy. The SCSES demonstrated convergent validity and discriminant validity with the select battery of measured concepts and sufficient internal consistency reliability (coefficient alpha = .87). Conclusions: The SCSES remains a valid and reliable measure of SCD self-efficacy among adults when used in anonymous, online research.

Context Limited research has examined racial disparities in symptom burden prior to chemotherapy initiation, during and at the chemotherapy completion. Objective To describe and compare the symptom burden (fatigue, pain, and physical functioning) and change over time between Black and White women receiving Early-Stage Breast Cancer (ESBC) chemotherapy while considering social determinants of health. Methods A longitudinal, repeated measures comparative design was employed. Time points of symptom measurement (PROMIS domains) at baseline, mid and end point were adjusted as per patient chemotherapy schedule. Linear mixed models were applied. Results There were 149 patients, 36% Black 64% White (54 ± 12 years) recommended to receive ESBC chemotherapy with adequate data for symptom analysis. Pain Main effect of race was significant (F(1, 390) = 29.43, P < .001) for pain.Black patients experienced significantly higher pain scores compared to White patients at pretherapy (Mean Difference; MD = 3.7, P = .034), midpoint (MD = 5.8, P = .002), and endpoint (MD = 7.8, P < .001). In the adjusted model, Black race and higher BMI were significant predictors of higher pain scores. Black patients experienced significant deterioration in pain over time. Fatigue The scores for fatigue increased significantly from baseline for Black patients by endpoint (MDT1-T3 = 8.7, P < .001) and for White patients at midpoint (MDT1-T2 = 5.7) and at endpoint (MDT1-T3 = 10.1, P < .001). In the adjusted model, higher BMI predicted worse fatigue scores. Physical function Black patients had significantly lower physical function scores compared to White patients at midpoint (MD = 4.0, P = .027). Physical function decreased by endpoint in Black (MDT1-T3 = 7.8, P < .001), and White patients (MDT1-T3 = 7.7, P < .001). In the adjusted model, only higher BMI and cardiopulmonary comorbidities significantly predicted worse physical function. Conclusion Symptom burden significantly increased over the course of chemotherapy for all patients. Scores for pain and physical function were higher overall for Black patients and deteriorated at a greater rate for Black vs. White women over the course of chemotherapy. BMI was a significant predictor of pain, fatigue, and physical function, this assessment holds implications for proactive assessment and mitigation strategies.

Introduction:Accurate assessment of pain severity is important for caring for patients with sickle cell disease (SCD). The Brief Pain Inventory was developed to address limitations of previous pain-rating metrics and is available in a short form (BPI-SF). However, the BPI-SF is a self-report scale dependent on patient comprehension and interpretation of items. Objective:To examine patterns in how patients completed the BPI-SF and determine whether incorrectly completing the BPI-SF was related to cognitive functioning or education. Methods:A secondary analysis was completed using data from a study examining brain aging and cognitive impairment in SCD. T-tests were performed to examine whether neurocognitive function (immediate and delayed memory, visuospatial skills, attention, and language), word reading, and years of education differed based on correct BPI-SF completion. Results:The sample (n = 71) was 43.7% male, 98.6% African American or mixed race. Of that, 53.5% had sickle cell anemia, and the mean years of education was 13.6. Overall, 21.1% of participants (n = 15) incorrectly completed the BPI-SF pain severity items, and 57.7% completed the body map item incorrectly. Those who completed the severity items incorrectly had statistically significant differences in education. Group differences in neurocognitive function were no longer significant after familywise error rates were controlled for. Literacy was not associated with error rates. Conclusion:Education level may influence patients' ability to correctly complete the BPI-SF. Findings suggest that careful consideration is warranted for use of the BPI in patients with SCD. Recommended revisions to the BPI include simplifying the language, shortening sentence length, and clearly specifying the timeframes.

Painimation, a novel digital pain assessment tool, allows patients to communicate their pain quality, intensity, and location using abstract animations (painimations) and a paintable body image. This study determined the construct validity of painimations and body image measures by testing correlations with validated pain outcomes in adults with sickle cell disease (SCD). Analyses used baseline data from a multisite randomized trial of 359 adults with SCD and chronic pain. Participants completed questionnaires on demographics, pain severity, frequency and interference, catastrophizing, opioid use, mood and quality of life, plus the Painimation app. Participants were categorized by selected painimations, and were split into groups based on the proportion of painted body image. Potential confounding was evaluated by age, gender, race, education, disability, site, depression, and anxiety. The 'shooting' painimation was strongly associated with daily pain intensity, pain interference, frequency, and severity. 'Electrifying' was associated with daily pain and opioid misuse, while greater body area in pain correlated with worse outcomes across all pain measures. Both painimations and body image measures correlated with validated pain outcomes, quality of life and mental health measures. This demonstrates animations and body image data can assess SCD pain severity, potentially with more accuracy than a 0-10 scale. Future research will explore whether Painimation can differentiate biological and psychosocial pain components. Perspective: This article presents the preliminary construct validity of Painimation in SCD by examining the associations of "painimations" and body area image data with daily e-diary and traditional self-report pain outcomes.

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.

Presentation Date: 6/9/2024 Presentation Start Time: 3:00:00 PM Patients with sickle cell disease (SCD) are highly vulnerable to pain, cognitive problems, and depression compared to their healthy peers. A rich literature has shown that pain affects cognitive function and that the mechanism of action through which this takes place (i.e., mediation) is, at least in part, emotional (e.g., depression). However, there is limited published research examining the impact of depression in SCD. In our study, we compared depression, pain, and executive function between a group of adults with SCD and a demographically matched control group. We then examined depression’s role as a mediator between pain and executive function. Our study included 97 adult patients (Mage = 35.78 years, SD = 11.64; 55 females) with SCD receiving hematological care at a large medical center in the northeastern United States. The institution’s IRB approved the study, which involved collection of biopsychosocial and neuropsychological data from participants. Rating scales used in the current study included the Patient Health Questionnaire-9 (PHQ-9), Brief Pain Inventory (BPI), Digit Symbol Substitution Test (DSST), and Delis-Kaplan Executive Function System (DKEFS) Trails, Verbal Fluency, and Color-Word Interference subtests. In addition, we collected data using the same rating scales and tests from a demographically matched group of 84 healthy controls (Mage = 36.66, SD = 11.49; 50 females). However, not all participants in either group completed all scales/tests. After adjusting for covariates, the SCD group rated themselves as experiencing significantly more depression symptoms (PHQ-9) (t(91.564) = -3.832, p = < .001) in daily life than the control group. The SCD group endorsed more pain on the BPI than the control group, which approached significance (p = .053) with a medium effect size (adjusted R2 = .193). Lack of significance was likely influenced by the small number of healthy controls who completed the BPI (n = 12). Independent samples t-tests corrected for familywise error rate using Bonferroni corrections showed that the SCD group significantly underperformed the control group on the DSST (t(143) = 3.728, p = < .001), DKEFS Color Word Interference, Condition 3: Final Weighted Combined Score (t(140) = 3.526, p = < .001), and DKEFS Color Word Interference and Condition 4: Final Weighted Combined Scaled Score (t(139) = 3.363, p = < .001). Using Andrew Hayes’s PROCESS mediation macro, results showed a significant indirect effect such that depression (PHQ-9) fully mediated the association between pain (BPI) and performance on DSST, DKEFS Color Word Interference, Condition 3: Final Weighted Combined Score, and Color Word Interference and Condition 4: Final Weighted Combined Scaled Score (Table 1, Figure 1). The same mediation analyses were conducted for the healthy control group and did not indicate that depression mediated the association between pain and cognitive function. As has been found in prior research, the SCD group in our study endorsed more depression and pain and exhibited more executive function problems than a group of healthy controls. Consistent with research in other chronic pain populations, depression significantly mediated the association between pain and executive function in adult patients with SCD. Depression may be a focus for treatment to improve executive function in patients with SCD, but more research is needed to substantiate these findings, including studies with larger samples.

Abstract Purpose: The purpose of this study was to compare prevalent symptoms (pain, fatigue, and physical function) and changes over time between Black and White women undergoing chemotherapy for early-stage breast cancer (ESBC) employing a longitudinal, repeated measures design over the course of ESBC. Methods: Data collected as per protocol of 1R01MD012245, comparing racial differences in chemotherapy tolerance and dose modifications during chemotherapy treatment at baseline, midpoint, and endpoint, tailored to each patient's individual chemotherapy schedule. Race was collected by patient self-report and chart review. Symptom burden (fatigue, pain, and physical functioning) was measured by the PROMIS-29 Profile v 2.0). Area deprivation was measured using the Area Deprivation Index (ADI). Linear mixed models were used to assess racial differences in symptom burden across timepoints, and changes in symptom burden over time, adjusting for ADI. Results: A total of 147 patients participated in this study (36% Black and 64% white). Pain: Black patients reported significantly higher pain scores than White patients at pretherapy (MD=3.7, p=.034), midpoint (MD=5.8, p: 0.002), and endpoint (MD=7.8, p<.001). Even after adjusting for area deprivation, this disparity persisted (F(1, 390)=29.43, p<.001), with Black patients having higher pain scores at midpoint (MD=4.7, p: 0.02) and endpoint (MD=7.8, p<.001). Pain scores worsened over time for Black patients, increasing significantly by the end of chemotherapy (MDT1-T3 =6.2, p=.010; MDT2-T3=5.8, p=.024). No significant changes in pain scores were observed over time among White patients. Fatigue: After adjusting for area deprivation, fatigue significantly increased at the endpoint (MDT1-T3=8.9, p<.001) for Black patients. Among White patients, fatigue increased at midpoint (MDT1-T2=5.7) and continued to worsen at the endpoint (MDT1-T3=10.1, p<.001; MDT2-T3=4.3, p=.017). Physical Function: Black patients had significantly lower physical function than White patients at the midpoint (MD=4.0, p=.027). By the end of chemotherapy, physical function deteriorated significantly for Black patients (MDT1-T3=7.8, p<.001), and White patients (MDT1-T3=7.7, p<.001; MDT2-T3=4.8, p=.002). Correlations between the ADI and symptom severity and physical function revealed that living in more deprived areas was associated with greater pain severity (r=-.227, p=.002, 56.3 vs. 50.1) and worse physical function (r=-.190, p=-.035, 40.6 vs. 42.4) at the completion of chemotherapy. Conclusions: The findings indicate that race and area deprivation are associated with symptom trajectories over the course of ESBC chemotherapy. Further research is warranted on how to best assess and relieve symptom burden among Black ESBC patients so that existing disparities in treatment and treatment outcomes are not perpetuated. Citation Format: Elham Nasrollahi, Hiba Abujaradeh, Susan Mazanec, Julia O'Brien, Isabelle M. Schlemmer, Margaret Rosenzweig. Racial disparities in symptom burden among women receiving early stage breast cancer chemotherapy [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 2135.

Abstract Despite the burden of chronic pain in sickle cell disease (SCD), nonpharmacological approaches remain limited. This multisite, randomized trial compared digital cognitive behavioral therapy (CBT) with a digital pain/SCD education program (“Education”) for managing pain and related symptoms. Participants were recruited virtually from seven SCD centers and community organizations in the United States. Adults (aged ≥18 years) with SCD-related chronic pain and/or daily opioid use were assigned to receive either CBT or Education for 12 weeks. Both groups used an app with interactive chatbot lessons and received personalized health coach support. The primary outcome was the change in pain interference at six months, with secondary outcomes including pain intensity, depression, anxiety, quality of life, and self-efficacy. Of 453 screened participants, 359 (79%) were randomized to CBT (n = 181) or Education (n = 178); 92% were Black African American, and 66.3% were female. At six months, 250 participants (70%) completed follow-up assessments, with 16 (4%) withdrawals. Engagement with the chatbot varied, with 76% connecting and 48% completing at least one lesson, but 80% of participants completed at least one health coach session. Both groups showed significant within-group improvements in pain interference (CBT: −2.13; Education: −2.66), but no significant difference was observed between them (mean difference, 0.54; P = .57). There were no between-group differences in pain intensity, depression, anxiety, or quality of life. High engagement with health coaching and variable engagement with digital components may explain the similar outcomes between interventions in this diverse, hard-to-reach population.

Health-related stigma, a form of devaluation related to a health condition, is common in individuals with sickle cell disease (SCD). Pain is the hallmark symptom of SCD, and health-related stigma is often described during care-seeking for pain management. Few published instruments measure health-related stigma in individuals with SCD. This study builds on the psychometrics of the 30- and 40-item Sickle Cell Disease Health-Related Stigma Scale (SCD-HRSS). In a sample of 197 adults with SCD, the results support the reliability and validity of a 21-item scale, the SCD-HRSS-Short Form, with an overall Cronbach’s alpha reliability of 0.91 and discriminant validity with the PROMIS-29 subscales (anxiety, depressive symptoms, pain interference, physical fatigue, sleep, and role satisfaction). A shorter yet reliable and valid scale may decrease the burden for this underrepresented, minoritized population while still providing important information regarding their experiences of stigmatization.

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 or 2) the adapted version. Baseline measures for depression, anxiety, pain, and self-efficacy were completed at the start of the study and again at post-intervention (minimum 4 weeks). Results Compared to baseline, mean scores for pain decreased an average of 3.29 ( p = 0.03) on a 10-point scale, self-efficacy improved 3.86 points ( p = 0.007) and depression symptoms decreased 5.75 points ( p = 0.016) for the group that received the adapted app. On average, control participants engaged with the app 5.64 times while the participants in the experimental group engaged 8.50 times ( p = 0.40). 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, this study 1) demonstrated the feasibility of implementing socially relevant changes into a mental health app and 2) indicated that 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. Trial registration This trial (NCT04587661) was registered on August 12th, 2020.

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.

Introduction: Patients with sickle cell disease (SCD) are highly vulnerable to pain and depression compared to their healthy peers. They also are at high risk of experiencing discrimination due to a combination of racial biases and stigma associated with SCD. Discrimination can have negative psychological effects and lead to poor health outcomes including increased pain. However, there is limited research in SCD examining the link between racial discrimination and pain, and how depression may mediate this association. A recent study found that depression significantly mediated the association between racial discrimination in the healthcare setting and pain severity and interference in adults with SCD. This study lacked a comparison group of non-SCD racial minorities to determine to what extent the link between discrimination and pain was specific to SCD. Thus, in the current study we sought to extend prior findings by comparing depression, pain, and racial discrimination between a group of adults with SCD and a demographically matched control group. We then examined whether depression in adults with SCD mediated the racial discrimination - pain association. Methods: Our study included 96 adults ( M age = 35.22 years, SD = 11.24; 55 females) with SCD receiving hematological care at a large medical center in the northeastern United States, and 84 demographically matched non-SCD controls ( M age = 36.66, SD = 11.49; 50 females). The institution's IRB approved the study, which involved collection of biopsychosocial data from participants. Rating scales used in the current study included the Experiences of Discrimination Scale (EOD), Beck Depression Inventory-2 (BDI-2), and Brief Pain Inventory (BPI). Results: After adjusting for covariates, the SCD group rated themselves as experiencing significantly more depression (BDI-2) ( t(95) = -1.997, p = 0.024) in daily life than the control group. Discrimination (EOD) was not significantly different between groups ( t(138) = -1.029, p = 0.305). The SCD group endorsed marginally greater 0-10 pain severity on the BPI than the control group, which approached significance ( p = .053) with a medium effect size ( adjusted R 2 = .193). Lack of significance was likely influenced by the small number of non-SCD controls who completed the BPI ( n = 12). In the SCD group, depression was significantly associated with both pain ( r = .509, p = .004) and discrimination ( r = .497, p = .005). Discrimination was not significantly associated with pain ( r = .219, p = .245). Using Andrew Hayes's PROCESS mediation macro, results showed a significant indirect effect in that depression (BDI-2) fully mediated the association between racial discrimination (EOD) and pain ratings (BPI) (Table 1, Figure 1). No mediation was found using the same analyses in the control group. Conclusion: The SCD and non-SCD groups reported experiencing similar levels of racial discrimination but the SCD group reported higher levels of depression and pain. In the SCD group, we replicated prior findings showing that depression mediated the associated between discrimination and pain. This suggests that it is an individual's response to an external stressor, and not the stressor itself, that contributes to poor disease outcomes. SCD primarily impacts Βlacks/African Americans in the United States, and these patients may experience unique interactions between experiences of discrimination and mental health that lead to increased pain. Depression may be a focus for treatment to improve pain, but more research is needed to substantiate these findings and understand what physiological factors explain how depression can influence pain in SCD.

Introduction: Adults living with sickle cell disease (SCD) most frequently seek medical care due to pain. To determine the most efficacious treatment plan for patients presenting with pain, providers must first accurately assess and diagnose the pain. Unfortunately, the current approaches for assessing pain are inadequate. Combined with medical provider biases, patients can often have their pain symptoms misinterpreted, ignored, or blatantly dismissed. To address this issue, we partnered with stakeholders, human-centered designers, and software engineers to design a novel pain assessment tool, called Painimation. Painimation allows patients to communicate their pain quality, intensity, and location using abstract animations and a paintable body image. Painimation has been validated in a general population with chronic pain, but there is limited data validating this approach in SCD. Preliminary data on the use of Painimation by adults with SCD (N = 67) found that those who described their pain using the “throbbing” animation had less severe pain symptoms than those endorsing the “shooting” animation. Objective: To replicate and extend prior findings by determining whether pain animations and body image data are associated with pain outcomes in a large cohort of adults with SCD. We hypothesized that the presence of shooting pain and greater body surface areas affected by pain would be associated with more severe pain outcomes and mental health symptoms. Methods: We performed a secondary analysis on baseline data from the “Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell via Mobile Application (CaRISMA)” Trial-a multisite randomized, controlled trial in adults with SCD and chronic pain. Eligible patients were randomized 1:1 to either digital cognitive behavioral therapy or digital education; in addition, both arms received at least 12 weeks of health coach support. At baseline, participants completed a battery of questionnaires and tracked their pain intensity (0-10) by the Visual Analog Scale (VAS) and mood daily via a mobile app. The Painimation app presents a front and back 2-dimensional body image that is paintable to indicate areas affected by pain. Users choose from abstract animations intended to represent different pain qualities; the intensity of the animations can be adjusted, and up to three can be selected. For the purpose of the analyses, participants were categorized into “Shooting Pain” vs “No Shooting Pain” and “Throbbing with Shooting and Stabbing” vs “Throbbing Alone,” based on our prior study. Participants were also split into groups based on whether the proportion of the body image painted was less than the median (<9.8% vs >=9.8%). Baseline characteristics and demographics were compared between groups, and multivariable regressions were used to estimate covariate-adjusted associations with the following outcomes at baseline: daily pain, Patient Reported Outcomes Measurement Information System (PROMIS) pain interference scale, Pain Catastrophizing Scale (PCS), Current Opioid Misuse Measure (COMM-9), and Adults Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) pain severity and frequency. Results: The trial enrolled 359 adults, mean age 36.3 (SD = 10.5), 66% female, 93% Black race. The “Shooting” painimation and greater body image scores were associated with all outcomes in univariate analyses (all p<0.01; Table 1) except for the proportion of “happy” mood days and anxiety scores. After controlling for age, depression, anxiety, % body image, and site, the shooting animations were independently associated with greater daily pain intensity (beta = 0.64; p = 0.046). After controlling for age, depression, and site, greater body image score was associated with daily pain intensity (beta = 1.18; p < 0.001), pain interference (beta = 2.87; p < 0.001), ASCQ-Me pain frequency (beta = 3.91; p =< 0.005), and ASCQ-Me pain severity (beta = 4.50; p = 0.002). Conclusion: Both the “shooting” animation and body image measures were associated with more severe pain outcomes. This study demonstrates that animations and body image data can be used to assess pain severity in SCD, more objectively than the 0-10 numeric VAS scale. Future studies should explore whether pain location and specific animation selected are associated with pain etiology, and determine whether this approach can differentiate different types of pain in SCD.

Background: Patients with sickle cell disease (SCD) suffer a significant disease burden that affects their psychosocial well-being. Digital cognitive-behavioral therapy (CBT) has been utilized in other patient populations and shown to have clinical benefits. Although evidence-based, non-pharmacological interventions for pain management are widely used in other populations, this is not well studied in SCD. There are currently no large-scale, adequately powered clinical trials that evaluate the effectiveness and dissemination potential of digital behavioral pain management interventions for adults with SCD. Objective: The primary goal was to compare the effectiveness of two mobile-phone-delivered programs: 1) digital CBT program tailored for adults with SCD (CBT); or 2) pain and SCD education (Education) for reducing pain symptoms. The secondary goal was to assess whether baseline depression symptoms moderated the effect of these interventions on pain outcomes. Methods: Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell via Mobile Application (CaRISMA) is a multisite, randomized, pragmatic, comparative effectiveness trial conducted at seven comprehensive sickle cell centers and several community-based organizations in the U.S. The study enrolled adults with SCD who reported chronic pain or using short or long-acting opioids daily. Participants were randomized in a 1:1 ratio to receive either the CBT or Education programs. Both programs utilized identical Facebook Messenger chatbot apps, only the content differed. All intervention participants received health coach support involving weekly phone calls or text messages for a duration of 12 weeks. Participants completed follow up assessments at 3 and 6 months, and daily e-diary entries of 0-10 pain numerical rating scale, mood, and opioid use. The primary outcome was the 6-month change in the PROMIS pain interference. Secondary outcomes included average daily pain intensity for a 2-week period at each time point, change in mean % body area affected by pain (measured by a ‘paintable’ body image within the mobile app), PHQ-9 depression, GAD-7 anxiety, Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) quality of life (social functioning and emotional impact), and Sickle Cell Self-Efficacy Scale (SCSES). Generalized linear mixed models were used to compare changes in 6-month outcomes between study arms after accounting for design variables (study site and baseline depression). Results: Of the 574 participants screened for eligibility, 359 (63%) were consented and randomized (178 to CBT and 181 to Education). Seventy-five percent of participants connected with the chatbot but only 47% completed at least one CBT/education lesson. However, 80% of participants had at least one text message, phone or video session with a health coach. At 6-months, there was a significant decline in pain interference within each arm (CBT [-2.13, 95%CI (-3.42, -0.84)] and Education [-2.66, 95%CI (-3.97, -1.36)]); however, this decline did not differ between arms (p=0.57). There was not a significant 6-month change in daily pain intensity for either arm, however, for % body area covered in pain, both CBT and education conferred a similar relative decrease, 19.2% and 17.1%, respectively. There were significant 6-month improvements within-arms for PHQ-9, GAD-7, and both ASCQ-Me measures, but no between-arm differences emerged. (Table 1). Of these, only the 6-month change in ASCQ-Me emotional impact approached a significant difference between arms with digital CBT conferring slightly greater improvement in scores, 3.51 (95%CI: 2.29, 4.73) compared to education,1.79 (95%CI: .55, 3.04; p=.05). Baseline PHQ depression score (>= 10 vs < 10) did not moderate the effect of treatments on pain interference (p=0.52). Conclusions: Preliminary trial findings suggest that both digital CBT and Education, with health coach support, are effective approaches for management of SCD pain and mental health symptoms. Most participants connected with a health coach and may have derived benefit from this support, however, poor engagement with the digital CBT and education component of the study may have limited the study's ability to detect between arm differences. Secondary analyses will examine the effect of intervention engagement on treatment outcomes.

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

Little is known about the relationships among self-efficacy, social determinants of health, and health outcomes in adults living with sickle cell disease (SCD). We conducted mediation analyses examining the relationships among health literacy, perceived stigma, self-efficacy, and health outcomes in an online cohort of adults living with SCD. The health outcomes explored were physical and mental health-related quality of life (HRQOL) and pain interference; covariates included gender, disease severity, and depressive symptoms. Data came from a cross-sectional, descriptive study of 60 adults with SCD. Perceived stigma and self-efficacy had significant relationships with the study outcomes, while health literacy did not. Self-efficacy partially mediated the relationship between perceived stigma and physical HRQOL, when controlling for depressive symptoms. Future research should investigate the influence of stigma and self-efficacy on health outcomes in patients with SCD and consider stigma when creating interventions to modify self-efficacy.

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.

AbstractAims and objectivesThe purpose of this study was to report the psychometric properties, including validity and reliability, of the decision fatigue scale (DFS).BackgroundDecision fatigue may impair nurses’ ability to make sound clinical decisions and negatively impact patient care. Given the negative impact of the COVID‐19 pandemic on psychological well‐being and the workplace environment, decision fatigue may be even more apparent among clinical nurses. Valid assessment of this condition among clinical nurses may inform supportive interventions to mitigate the negative sequelae associated with states of decision fatigue.DesignThis study was a secondary analysis of a parent study using a cross‐sectional descriptive design.MethodsA convenience sample of 160 staff nurses was recruited online from across the United States. Participants completed a demographic questionnaire and subjective measures of decision fatigue, nursing practice environment scale and traumatic stress. Exploratory factor analysis (EFA), correlation coefficients and internal consistency reliability coefficients were computed to examine the DFS’s validity and reliability within this sample.ResultsThe EFA yielded a single factor, 9‐item version of the DFS. The DFS scores were strongly correlated with traumatic stress and moderately correlated with the nursing practice environment, and the scale displayed appropriate internal consistency.ConclusionsThis is the first known study to provide evidence of the DFS’s validity and reliability in a sample of registered nurses working during the COVID‐19 pandemic. The results of this study provide evidence of a reliable and valid assessment instrument for decision fatigue that can be used to measure the burden of decision‐making among registered nurses.Relevance to clinical practiceGiven the relationship between traumatic stress and the nursing work environment, decision fatigue may be a modifiable target for interventions that can enhance the quality of decision‐making among clinical nurses.