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Sleep changes over the human life span, and it does so across multiple dimensions. We used individual-level cross-sectional data to characterize age trends and sex differences in actigraphy and self-report sleep dimensions across the healthy human life span.The Pittsburgh Lifespan Sleep Databank consists of harmonized participant-level data from sleep-related studies conducted at the University of Pittsburgh (2003-2019). We included data from 1065 (n = 577 female; 21 studies) Pittsburgh Lifespan Sleep Databank participants aged 10 to 87 years without a major psychiatric, sleep, or medical condition. All participants completed wrist actigraphy and the self-rated Pittsburgh Sleep Quality Index. Main outcomes included actigraphy and self-report sleep duration, efficiency, and onset/offset timing, and actigraphy variability in midsleep timing.We used generalized additive models to examine potentially nonlinear relationships between age and sleep characteristics and to examine sex differences. Actigraphy and self-report sleep onset time shifted later between ages 10 and 18 years (23:03-24:10 [actigraphy]; 21:58-23:53 [self-report]) and then earlier during the 20s (00:08-23:40 [actigraphy]; 23:50-23:34 [self-report]). Actigraphy and self-report wake-up time also shifted earlier during the mid-20s through late 30s (07:48-06:52 [actigraphy]; 07:40-06:41 [self-report]). Self-report, but not actigraphy, sleep duration declined between ages 10 and 20 years (09:09-07:35). Self-report sleep efficiency decreased over the entire life span (96.12-93.28), as did actigraphy variability (01:54-01:31).Awareness of age trends in multiple sleep dimensions in healthy individuals-and explicating the timing and nature of sex differences in age-related change-can suggest periods of sleep-related risk or resilience and guide intervention efforts. more...

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. CLINICALTRIAL ClinicalTrials.gov NCT04587661; https://clinicaltrials.gov/ct2/show/NCT04587661 more...

Objective A consortium of 8 academic child and adolescent psychiatry programs in the United States and Canada examined their pivot from in-person, clinic-based services to home-based telehealth during the COVID-19 pandemic. The aims were to document the transition across diverse sites and to present recommendations for future telehealth service planning. Method Consortium sites completed a Qualtrics survey assessing site characteristics, telehealth practices, service use, and barriers to and facilitators of telehealth service delivery prior to (pre) and during the early stages of (post) the COVID-19 pandemic. The design is descriptive. Results All sites pivoted from in-person services to home-based telehealth within 2 weeks. Some sites experienced delays in conducting new intakes, and most experienced delays establishing tele−group therapy. No-show rates and use of telephony versus videoconferencing varied by site. Changes in telehealth practices (eg, documentation requirements, safety protocols) and perceived barriers to telehealth service delivery (eg, regulatory limitations, inability to bill) occurred pre−/post−COVID-19. Conclusion A rapid pivot from in-person services to home-based telehealth occurred at 8 diverse academic programs in the context of a global health crisis. To promote ongoing use of home-based telehealth during future crises and usual care, academic programs should continue documenting the successes and barriers to telehealth practice to promote equitable and sustainable telehealth service delivery in the future. more...

Introduction: Increased numbers of African Americans (AAs) are being diagnosed with inflammatory bowel disease (IBD), little is known about the influence of culture on their coping. Purpose: To explore the beliefs and experiences of AAs with IBD and coping in the context of their culture. Method: Twelve AA adults with IBD were interviewed and observed using focused ethnography. Results: Data analysis revealed four themes: (1) spending time living in the bathroom, (2) time and food restricted eating practices and cultural food avoidance, (3) dealing with chronic stress and perceived racial injustice, and (4) the practice of seclusion to manage bathroom urgency and emotions of fear, anxiety, and embarrassment. Discussion: Participants described coping and culture with experiences similar to other IBD populations, except in the area of perceived racial injustice. Opportunities for nurses to assist with stressors related to bathroom access, cultural eating practices, and participating in activities outside their homes. more...

Background The level of inflammatory bowel disease (IBD) training in general gastroenterology fellowship is often insufficient to prepare trainees to deliver advanced IBD care in practice. Advanced IBD fellowships have been developed to fill this training gap, but there is no established curriculum, and significant variability exists across programs. Entrustable professional activities (EPAs) are practical and realistic objectives that define essential tasks of a specialty that physicians should master to be competent during independent practice. The American College of Gastroenterology (ACG) and Crohn’s & Colitis Foundation (Foundation) established a task force to develop and appraise EPAs for advanced IBD fellowship. Methods Entrustable professional activities were developed using a multistep approach in a similar manner to other specialties. Initial EPAs identified via focus groups were evaluated, critiqued, and changed using an iterative model of feedback. The final EPAs were selected after the task force conducted a 3-phase modified Delphi method consisting of 2 sequential rounds of web-based voting and an in-person consensus meeting. Results Ten EPAs for advanced IBD fellowship were established including detailed descriptions with the associated knowledge, skills, and attitudes for each that can serve as curricular milestones. Conclusion Ten EPAs describing the core work of an advanced IBD fellowship–trained physician have been established by a multisociety task force. Creating EPAs for an advanced curriculum comes with unique challenges, particularly the need to prevent duplication of prior training competencies while demonstrating the potential for unique milestones. more...

PURPOSE OF REVIEW: The world is experiencing the evolving situation associated with the outbreak of the Corona Virus Disease-2019 (COVID-19) virus, and there is more of need than ever for stress management and self-care. In this article, we will define the physiological, psychological and social aspects, stages, and components of stress reactions in the context of COVID-19, review the relevant literature on stress reactions, and offer some guidance on how to help patients mitigate the physiological and psychological impact of the pandemic through resilience-building techniques. RECENT FINDINGS: There is continued evidence that the fight or flight response involves activation throughout the body at physiological, biochemical and immune levels. This response can be mitigated through increasing parasympathetic nervous system activation as well as cognitive and behavioral interventions. SUMMARY: This article will review the stress, provide a theoretical layout to predict upcoming response, and offer clinicians some practical interventions to employ as the stress of the COVID-19 pandemic continues. more...

BACKGROUND The COVID-19 pandemic has accelerated the adoption of digital tools to support individuals struggling with their mental health. The use of a digital intervention plus human coaching (“dual” intervention) is gaining momentum in increasing overall engagement in digital cognitive behavioral interventions (dCBIs). However, there is limited insight into the methodologies and coaching models used by those deploying dual interventions. To achieve a deeper understanding, we need to identify and promote effective engagement that leads to clinical outcomes versus simply monitoring engagement metrics. Motivational interviewing (MI) is a collaborative, goal-oriented communication approach that pays particular attention to the language of change and is an effective engagement approach to help people manage mental health issues. However, this approach has been traditionally used for in-person or telephonic interventions, and less is known about the application of MI to digital interventions. OBJECTIVE We sought to provide a dual intervention approach and address multiple factors across two levels of engagement to operationalize a dCBI that combined cognitive behavioral therapy–based techniques and MI-based interactions between the digital health coach (DHC) and user. METHODS We reviewed hundreds of digital exchanges between DHCs and users to identify and improve training and quality assurance activities for digital interventions. RESULTS We tested five hypotheses and found that: (1) users of a dual digital behavioral health intervention had greater engagement levels than users of a noncoached intervention (PPPP=.02). CONCLUSIONS To our knowledge, this pilot was the first of its kind to test the application of MI to digital coaching protocols, and it demonstrated the value of MI proficiency in digital health coaching for enhanced engagement and health improvement. Further research is needed to establish coaching models in dCBIs that incorporate MI to promote effective engagement and optimize positive behavioral outcomes. more...

Background Mental health diagnoses (MHDs) were identified as significant drivers of inflammatory bowel disease (IBD)-related costs in an analysis titled “Cost of Care Initiative” supported by the Crohn’s & Colitis Foundation. In this subanalysis, we sought to characterize and compare IBD patients with and without MHDs based on insurance claims data in terms of demographic traits, medical utilization, and annualized costs of care. Methods We analyzed the Optum Research Database of administrative claims from years 2007 to 2016 representing commercially insured and Medicare Advantage insured IBD patients in the United States. Inflammatory bowel disease patients with and without an MHD were compared in terms of demographics (age, gender, race), insurance type, IBD-related medical utilization (ambulatory visits, emergency department [ED] visits, and inpatient hospitalizations), and total IBD-related costs. Only patients with costs >$0 in each of the utilization categories were included in the cost estimates. Results Of the total IBD study cohort of 52,782 patients representing 179,314 person-years of data, 22,483 (42.6%) patients had at least 1 MHD coded in their claims data with a total of 46,510 person-years in which a patient had a coded MHD. The most commonly coded diagnostic categories were depressive disorders, anxiety disorders, adjustment disorders, substance use disorders, and bipolar and related disorders. Compared with patients without an MHD, a significantly greater percentage of IBD patients with MHDs were female (61.59% vs 48.63%), older than 75 years of age (9.59% vs 6.32%), white (73.80% vs 70.17%), and significantly less likely to be younger than 25 years of age (9.18% vs 11.39%) compared with those without mental illness (P < 0.001). Patients with MHDs had significantly more ED visits (14.34% vs 7.62%, P < 0.001) and inpatient stays (19.65% vs 8.63%, P < 0.001) compared with those without an MHD. Concomitantly, patients with MHDs had significantly higher ED costs ($970 vs $754, P < 0.001) and inpatient costs ($39,205 vs $29,550, P < 0.001) compared with IBD patients without MHDs. Patients with MHDs also had significantly higher total annual IBD-related surgical costs ($55,693 vs $40,486, P < 0.001) and nonsurgical costs (medical and pharmacy) ($17,220 vs $11,073, P < 0.001), and paid a larger portion of the total out-of-pocket cost for IBD services ($1017 vs $905, P < 0.001). Conclusion Patients whose claims data contained both IBD-related and MHD-related diagnoses generated significantly higher costs compared with IBD patients without an MHD diagnosis. Based on these data, we speculate that health care costs might be reduced and the course of patients IBD might be improved if the IBD-treating provider recognized this link and implemented effective behavioral health screening and intervention as soon as an MHD was suspected during management of IBD patients. Studies investigating best screening and intervention strategies for MHDs are needed. more...

Background:Crohn’s disease (CD) is an inflammatory condition that has deleterious effects on patients’ health-related quality of life (HRQoL). Demographic, clinical, and psychosocial factors contribute to variability in HRQoL; however, the influence of genetic variations related to altered inflammatory responses in individuals with CD is unknown. This exploratory study compared HRQoL scores across genotypes of functional genetic polymorphisms in cytokine candidate genes among individuals with CD.Method:This study used data and blood samples collected in a parent study in 39 patients with CD aged 15−30 years. Participant reports of HRQoL were collected using the Shortened Inflammatory Bowel Disease Questionnaire (SIBDQ). Genetic data were collected for 18 functional polymorphisms in eight cytokine candidate genes. SIBDQ scores were compared among genotypes using one-way, between-subjects analysis of variance.Results:SIBDQ scores differed across genotypes as follows: for IL-1R2 rs4141134 scores differed for total SIBDQ ( p = .004) and systemic ( p = .011), emotion ( p = .038), and social domains ( p = .025); for IL-10 rs1878672, scores differed for total SIBDQ ( p = .031) and social domain ( p = .008); for NFKB2 rs1056890, scores differed for social domain ( p = .041); for TNF-α rs1800629, scores differed for total SIBDQ ( p = .001) and bowel ( p = .026), systemic ( p = .014), and social domains ( p = .045).Conclusions:Findings on differences in SIBDQ scores across functional genetic polymorphisms in cytokine genes suggest potential mechanisms that contribute to variability in HRQoL in adolescents and young adults with CD. more...

This study quantifies the wide-ranging health care costs affecting patients living with IBD, including the annualized direct and indirect costs of care for patients with IBD, the longitudinal drivers of these costs, and the cost of care for newly diagnosed patients., Background The Crohn’s & Colitis Foundation’s Cost of Inflammatory Bowel Disease (IBD) Care Initiative seeks to quantify the wide-ranging health care costs affecting patients living with IBD. We aimed to (1) describe the annualized direct and indirect costs of care for patients with Crohn’s disease (CD) or ulcerative colitis (UC), (2) determine the longitudinal drivers of these costs, and (3) characterize the cost of care for newly diagnosed patients. Methods We analyzed the Optum Research Database from the years 2007 to 2016, representing commercially insured and Medicare Advantage–insured patients in the United States. Inclusion for the study was limited to those who had continuous enrollment with medical and pharmacy benefit coverage for at least 24 months (12 months before through 12 months after the index date of diagnosis). The value of patient time spent on health care was calculated as number of workplace hours lost due to health care encounters multiplied by the patients’ estimated average wage derived from the Bureau of Labor Statistics. Comparisons between IBD patients and non-IBD patients were analyzed based on demographics, health plan type, and length of follow-up. We used generalized linear models to estimate the association between total annual costs and various patient variables. Results There were 52,782 IBD patients (29,062 UC; 23,720 CD) included in the analysis (54.1% females). On a per-annual basis, patients with IBD incurred a greater than 3-fold higher direct cost of care compared with non-IBD controls ($22,987 vs $6956 per-member per-year paid claims) and more than twice the out-of-pocket costs ($2213 vs $979 per-year reported costs), with all-cause IBD costs rising after 2013. Patients with IBD also experienced significantly higher costs associated with time spent on health care as compared with controls. The burden of costs was most notable in the first year after initial IBD diagnosis (mean = $26,555). The study identified several key drivers of cost for IBD patients: treatment with specific therapeutics (biologics, opioids, or steroids); ED use; and health care services associated with relapsing disease, anemia, or mental health comorbidity. Conclusion The costs of care for IBD have increased in the last 5 years and are driven by specific therapeutics and disease features. In addition, compared with non-IBD controls, IBD patients are increasingly incurring higher costs associated with health care utilization, out-of-pocket expenditures, and workplace productivity losses. There is a pressing need for cost-effective strategies to address these burdens on patients and families affected by IBD. more...

Background Despite the growing evidence indicating the efficacy of digital cognitive behavioral interventions (dCBIs) for behavioral health (BH) treatment, broad and consistent use of such interventions has been limited by knowledge obtained in real-world settings, including factors that impact provider uptake/referral. Engaging providers early in the implementation process offers an opportunity to explore their needs and behaviors, integrate interventions into workflows, and better understand provider setting capabilities. Objective This study assessed providers’ views on the feasibility and acceptability of delivering a cognitive behavioral therapy (CBT)-based mobile app in multiple care settings. Methods Participating providers included BH and physical health (PH) providers from a women’s health center, an outpatient BH clinic, and both rural/urban primary care settings. All participating providers cocreated workflows through facilitated workshops, including establishing feedback loops between the project team and providers and identifying clinical champions at each site. Over a 12-week period, the providers referred adult patients experiencing anxiety or depression to a mobile app-based dCBI, RxWell, and provided other indicated treatments as part of usual care. Referrals were completed by the providers through the electronic medical record. To better understand facilitators of and challenges in integrating RxWell into routine practice and perceptions of sustainability, a series of qualitative interviews was conducted. Interview data were analyzed to identify major themes using an inductive content analysis approach. Results A total of 19 provider interviews were conducted to discover motivators and barriers for referring RxWell. The providers benefited from a focused discussion on how to incorporate the referral process into their workflow, and knowing the app content was rooted in evidence. Although the providers believed engaging in experiential learning was important, they indicated that more education on the digital health coach role and how to monitor patient progress is needed. The providers thought patient engagement may be impacted by motivation, a lack of comfort using a smartphone, or preference for in-person therapy. The providers also expressed enthusiasm in continuing to refer the app. They liked the ability to provide patients with support between sessions, to have an extra treatment option that teaches BH exercises, and to have a CBT treatment option that overcomes barriers (eg, wait times, copays, travel) to traditional therapy modalities. Conclusions Digital intervention success in health care settings relies heavily on engagement of key stakeholders, such as providers, in both design and implementation of the intervention and focused evaluation within intended care setting(s). Scaling digital interventions to meet the mental health needs of patients in usual care settings leans on thoughtfully constructed and streamlined workflows to enable seamless referral of patients by providers. Our findings strongly suggest that providers are supportive of digital tool integration to support the mental health of patients and endorse its use within their routine workflow. more...

Recent literature supports the efficacy and efficiency of telemedicine in improving various health outcomes despite the wide variability in results. Understanding site-specific issues in the implementation of telemedicine trials for broader replication and generalizability of results is needed. Lessons can be learned from existing trials, and a blueprint can guide researchers to conduct these challenging studies using telemedicine more efficiently and effectively. This viewpoint presents relevant challenges and solutions for conducting multisite telemedicine trials using 7 ongoing and completed studies funded by the Patient-Centered Outcomes Research Institute portfolio of large multisite trials to highlight the challenges in implementing telemedicine trials. Critical issues of ensuring leadership and buy-in, appropriate funding, and diverse and representative trials are identified and described, as well as challenges related to clinical, informatics, regulatory, legal, quality, and billing. The lessons learned from these studies were used to create a blueprint of key aspects to consider for the design and implementation of multisite telemedicine trials. more...

Over the last year, the coronavirus disease 2019 (COVID-19) pandemic has resulted in profound disruptions across the globe, with school closures, social isolation, job loss, illness, and death affecting the lives of children and families in myriad ways. In an Editors' Note in our June 2020 issue, 1 our senior editorial team described this Journal's role in advancing knowledge in child and adolescent mental health during the pandemic and outlined areas we identified as important for science and practice in our field. Since then, the Journal has published articles on the impacts of the pandemic on child and adolescent mental health and service systems, 2-5 which are available in a special collection accessible through the Journal's website. 6 Alongside many opinion papers, the pace of publication of empirical research in this area is rapidly expanding, covering important issues such as increased frequency of mental health symptoms among children and adolescents 3,5,7-10 and changes in patterns of clinical service use such as emergency department visits. 11-14 As the Senior Editors prepared that Editors’ Note, they were acutely aware that the priorities that they identified were broad and generated by only a small group of scientists and clinicians. Although this had the advantage of enabling us to get this information out to readers quickly, we decided that a more systematic approach to developing recommendations for research priorities would be of greater long-term value. We were particularly influenced by the efforts of the partnership between the UK Academy of Medical Scientists and a UK mental health research charity (MQ: Transforming Mental Health) to detail COVID-19−related research priorities for “Mental Health Science” that was published online by Holmes et al. in The Lancet Psychiatry in April 2020. 15 Consistent with its focus on mental health research across the lifespan, several recommendations highlighted child development and children's mental health. However, a more detailed assessment of research priorities related to child and adolescent mental health was beyond the scope of that paper. Furthermore, the publication of that position paper preceded the death of George Floyd at the hands of Minneapolis police on May 25, 2020, which re-energized efforts to acknowledge and to address racism and healthcare disparities in the United States and many other countries. To build upon the JAACAP Editors’ Note 1 and the work of Holmes et al., 15 we conducted an international survey of professionals—practitioners and researchers—working on child and adolescent development and pediatric mental health to identify concerns about the impact of the pandemic on children, adolescents, and their families, as well as what is helping families navigate these impacts, and the specific research topics that are of greatest importance. more...

UNSTRUCTURED Recent literature supports the efficacy and efficiency of telemedicine in improving various health outcomes despite the wide variability in results. Understanding site-specific issues in the implementation of telemedicine trials for broader replication and generalizability of results is needed. Lessons can be learned from existing trials, and a blueprint can guide researchers to conduct these challenging studies using telemedicine more efficiently and effectively. This viewpoint presents relevant challenges and solutions for conducting multisite telemedicine trials using 7 ongoing and completed studies funded by the Patient-Centered Outcomes Research Institute portfolio of large multisite trials to highlight the challenges in implementing telemedicine trials. Critical issues of ensuring leadership and buy-in, appropriate funding, and diverse and representative trials are identified and described, as well as challenges related to clinical, informatics, regulatory, legal, quality, and billing. The lessons learned from these studies were used to create a blueprint of key aspects to consider for the design and implementation of multisite telemedicine trials. more...

Background Opioid use by patients with inflammatory bowel disease (IBD) has been associated with poorer health outcomes. This study describes socioeconomic characteristics; health utilization trends; and costs of patients with IBD and either no opioid prescriptions, or in 1 of 3 opioid duration categories based on Center for Disease Control guidelines: acute (0–30 days), moderate (31–90 days), or chronic (>90 days). We utilized the Cost of IBD Care Optum research database results for this study. Methods The Optum Research Database from years 2007 to 2016 including IBD patients with commercial or Medicare Advantage insurance in the United States was used. Additional inclusion criteria included continuous enrollment with medical and pharmacy benefit coverage for at least 24 months (12 months before and 12 months after the index date of IBD diagnosis). The association between costs and patient characteristics were assessed across a no opioid use group during this period and the 3 opioid duration groups. Results Among 51,178 IBD patients, 33,229 (64.93%) were part of the no opioid use group, while 13,635 (26.64%) were in acute, 1698 (3.32%) were in moderate, and 2616 (5.11%) were in chronic use groups, as determined by pharmacy claims data. Patients in the chronic group were more likely to be white (75.38%) compared to all the other groups (no opioid use, acute, and moderate), have attained less education (only high school diploma), have had lower incomes, and have had Medicare instead of commercial insurance. Patients across all opioid prescription groups were more likely to have had diagnoses associated with pain in the prior year, with rates increasing by the length of opioid prescription (63.68%, 80.17%, and 86.11% for acute, moderate, and chronic groups). Compared to the no-use group, the acute group had more ambulatory (outpatient) visits, while the chronic group had fewer. Emergency department visits and inpatient hospitalizations were higher in all 3 opioid groups compared to the no opioid use group. Ambulatory, emergency department, inpatient, and total (medical + pharmacy) costs were higher in all 3 opioid groups, compared to the no opioid use group, even after adjusting for demographic and clinical patient characteristics. Conclusions Among patients with IBD, increasing opioid use was associated with higher healthcare resource utilization and, concomitantly, higher healthcare costs during this period. more...

Dietary factors like sugar-sweetened beverage (SSB) consumption are known to influence disease course in a variety of illnesses; however, long-term outcomes are not well documented for inflammatory bowel disease.Does high consumption of SSBs lead to high healthcare utilization (ie, hospitalizations and emergency department visits), inflammation, and disease severity in patients with inflammatory bowel disease?A prospective cohort study was conducted from 2015 to 2019. Patients enrolled in the discovery study cohort were followed for 3 years, whereas patients in the validation cohort were followed for 2 years. They underwent nutrition assessment and received routine care. Dietary intakes of SSBs and fiber were quantified by a validated, self-reported questionnaire.For the discovery study cohort, 1133 adult patients were recruited from the University of Pittsburgh Medical Center Digestive Disease Clinic in Pittsburgh, PA. Eligible patients had a preexisting diagnosis of Crohn's disease or ulcerative colitis and had at least annual follow-up at this tertiary referral center. High SSB consumption was defined as 7 or more SSBs per week. Moderate was defined as2 but7 SSBs per week. Low SSB consumption was defined as 2 or fewer SSBs per week.Primary outcome was time to hospitalization and emergency department visits. Secondary outcomes assessed laboratory markers of disease severity and inflammation. Tertiary outcomes assessed time to hospitalization and emergency department visits in a subsequent independent cohort of patients.Multivariable logistic regression, Kaplan-Meier, and Cox proportional hazards modeling RESULTS: The discovery cohort included of 1,133 adult patients with inflammatory bowel disease (58% women, 70% with Chron's disease, 30% with ulcerative colitis, median age 46 years). Low SSB consumption, moderate SSB consumption, and high SSB consumption occurred in 57%, 17%, and 26% in the discovery cohort, respectively. Among patients without active disease at enrollment, high SSB consumption was associated with decreased time to hospitalization and emergency department visits when compared with low SSB consumption (hazard ratio 1.55, 95% CI 1.06 to 2.27; and hazard ratio 1.53, 95% CI 1.10 to 2.13). In terms of disease severity and inflammatory biomarkers, high SSB consumption was associated with increase odds of elevated erythrocyte sedimentation rate (odds ratio 2.04, 95% CI 1.31 to 3.18), elevated C-reactive protein level (odds ratio 1.60, 95% CI, 1.07-2.37), eosinophilia (odds ratio 1.88, 95% CI 1.06 to 3.335), and monocytosis (odds ratio 1.81, 95% CI 1.18 to 2.79) when compared with low SSB consumption after adjusting for baseline differences. Lastly, the validation cohort produced similar results to our primary outcome (ie, high SSB consumption was associated with decreased time to hospitalization and emergency department visits when compared with low SSB consumption).High SSB consumption was associated with decreased time to hospitalization and emergency department visits. Furthermore, high SSB consumption is associated with disease severity biomarkers and inflammation. Prospective studies assessing the therapeutic influence of nutrition counseling and decreased SSB consumption on long-term inflammatory bowel disease clinical course are warranted. more...

BACKGROUND Despite the growing evidence indicating the efficacy of digital cognitive behavioral interventions (dCBIs) for behavioral health (BH) treatment, broad and consistent use of such interventions has been limited by knowledge obtained in real-world settings, including factors that impact provider uptake/referral. Engaging providers early in the implementation process offers an opportunity to explore their needs and behaviors, integrate interventions into workflows, and better understand provider setting capabilities. OBJECTIVE This study assessed providers’ views on the feasibility and acceptability of delivering a cognitive behavioral therapy (CBT)-based mobile app in multiple care settings. METHODS Participating providers included BH and physical health (PH) providers from a women’s health center, an outpatient BH clinic, and both rural/urban primary care settings. All participating providers cocreated workflows through facilitated workshops, including establishing feedback loops between the project team and providers and identifying clinical champions at each site. Over a 12-week period, the providers referred adult patients experiencing anxiety or depression to a mobile app-based dCBI, RxWell, and provided other indicated treatments as part of usual care. Referrals were completed by the providers through the electronic medical record. To better understand facilitators of and challenges in integrating RxWell into routine practice and perceptions of sustainability, a series of qualitative interviews was conducted. Interview data were analyzed to identify major themes using an inductive content analysis approach. RESULTS A total of 19 provider interviews were conducted to discover motivators and barriers for referring RxWell. The providers benefited from a focused discussion on how to incorporate the referral process into their workflow, and knowing the app content was rooted in evidence. Although the providers believed engaging in experiential learning was important, they indicated that more education on the digital health coach role and how to monitor patient progress is needed. The providers thought patient engagement may be impacted by motivation, a lack of comfort using a smartphone, or preference for in-person therapy. The providers also expressed enthusiasm in continuing to refer the app. They liked the ability to provide patients with support between sessions, to have an extra treatment option that teaches BH exercises, and to have a CBT treatment option that overcomes barriers (eg, wait times, copays, travel) to traditional therapy modalities. CONCLUSIONS Digital intervention success in health care settings relies heavily on engagement of key stakeholders, such as providers, in both design and implementation of the intervention and focused evaluation within intended care setting(s). Scaling digital interventions to meet the mental health needs of patients in usual care settings leans on thoughtfully constructed and streamlined workflows to enable seamless referral of patients by providers. Our findings strongly suggest that providers are supportive of digital tool integration to support the mental health of patients and endorse its use within their routine workflow. more...

Youth with inflammatory bowel disease (IBD) often experience psychological difficulties, such as anxiety and depression. This randomized controlled study tested whether a 3-month disease-specific cognitive behavioral therapy (CBT) in addition to standard medical care versus standard medical care only was effective in improving these youth’s psychological outcomes. As this study was aimed at prevention, we included 70 youth (10–25 years) with IBD and symptoms of subclinical anxiety and/or depression, and measured psychological outcomes at 6- and 12-month follow-up. In general, participants in both groups showed improvements in anxiety, depression, health-related quality of life, social functioning, coping, and illness perceptions, sustained until 12 months follow-up. Overall, we found no differences between those receiving additional CBT and those receiving standard medical care only. We assume that this can be explained by the perceived low burden (both somatically and psychologically) or heightened awareness of psychological difficulties and IBD. ClinicalTrials.gov NCT02265588. more...

Declining life expectancy and increasing all-cause mortality in the United States have been associated with unhealthy behaviors, socioecological factors, and preventable disease. A growing body of basic science, clinical research, and population health evidence points to the benefits of healthy behaviors, environments and policies to maintain health and prevent, treat, and reverse the root causes of common chronic diseases. Similarly, innovations in research methodologies, standards of evidence, emergence of unique study cohorts, and breakthroughs in data analytics and modeling create new possibilities for producing biomedical knowledge and clinical translation. To understand these advances and inform future directions research, The Lifestyle Medicine Research Summit was convened at the University of Pittsburgh on December 4–5, 2019. The Summit's goal was to review current status and define research priorities in the six core areas of lifestyle medicine: plant-predominant nutrition, physical activity, sleep, stress, addictive behaviors, and positive psychology/social connection. Forty invited subject matter experts (1) reviewed existing knowledge and gaps relating lifestyle behaviors to common chronic diseases, such as cardiovascular disease, diabetes, many cancers, inflammatory- and immune-related disorders and other conditions; and (2) discussed the potential for applying cutting-edge molecular, cellular, epigenetic and emerging science knowledge and computational methodologies, research designs, and study cohorts to accelerate clinical applications across all six domains of lifestyle medicine. Notably, federal health agencies, such as the Department of Defense and Veterans Administration have begun to adopt “whole-person health and performance” models that address these lifestyle and environmental root causes of chronic disease and associated morbidity, mortality, and cost. Recommendations strongly support leveraging emerging research methodologies, systems biology, and computational modeling in order to accelerate effective clinical and population solutions to improve health and reduce societal costs. New and alternative hierarchies of evidence are also be needed in order to assess the quality of evidence and develop evidence-based guidelines on lifestyle medicine. Children and underserved populations were identified as prioritized groups to study. The COVID-19 pandemic, which disproportionately impacts people with chronic diseases that are amenable to effective lifestyle medicine interventions, makes the Summit's findings and recommendations for future research particularly timely and relevant. more...

Sleep disturbances and fatigue are common symptoms amongst patients with Crohn's disease (CD). The aim of this study was to test the feasibility and effects of a pragmatic, stepped-care intervention for the treatment of poor sleep quality and fatigue in adolescents and young adults with CD.This study is a two-phase open trial exploring interventions for sleep and fatigue. After the initial comprehensive assessment which included quantitative measures and an interview to evaluate sleep and physical and mental health, the 12-week intervention consisted of two sequential steps: 1) a brief behavioral therapy for sleep in inflammatory bowel disease (IBD) (BBTS-I; 4 weeks) and 2) adding the psychotropic medication, bupropion sustained release (BUP-SR; 8 weeks), for the subset of subjects continuing to experience fatigue.232 CD patients (median age=24, median sex=female) were approached over 18 months, of whom 112 screened positive on the Pittsburgh Sleep Quality Index (PSQI) and multi-dimensional fatigue inventory (MFI), with 68 CD patients completing the more comprehensive baseline assessment. Of the 68 patients, 52 participated in Phase I of the BBTS-I intervention. Following 4-weeks of the BBTS-I, there were significant improvements in sleep quality (p.001) and fatigue (p.001). As part of Phase II, of the 52 patients who met fatigue threshold criteria, 33 patients participated in the BUP-SR+BBTS-I arm while 19 participated in the BBTS-I only intervention group. After 8 weeks of Phase II, both intervention groups saw significant further improvement in sleep, fatigue, anxiety and depressive symptoms, but without significant differences between the two intervention groups.A stepped-care approach shows that we can improve sleep disturbance with BBTS-I in CD patients, but fatigue only partially improves. For a subset of patients who chose to add BUP-SR to their behavioral therapy, fatigue improves further but not to a statistically significant effect compared to behavioral therapy alone. more...

The Crohn'sColitis Foundation's Cost of Inflammatory Bowel Disease (IBD) Care Initiative seeks to quantify the wide-ranging health care costs affecting patients living with IBD. We aimed to (1) describe the annualized direct and indirect costs of care for patients with Crohn's disease (CD) or ulcerative colitis (UC), (2) determine the longitudinal drivers of these costs, and (3) characterize the cost of care for newly diagnosed patients.We analyzed the Optum Research Database from the years 2007 to 2016, representing commercially insured and Medicare Advantage-insured patients in the United States. Inclusion for the study was limited to those who had continuous enrollment with medical and pharmacy benefit coverage for at least 24 months (12 months before through 12 months after the index date of diagnosis). The value of patient time spent on health care was calculated as number of workplace hours lost due to health care encounters multiplied by the patients' estimated average wage derived from the Bureau of Labor Statistics. Comparisons between IBD patients and non-IBD patients were analyzed based on demographics, health plan type, and length of follow-up. We used generalized linear models to estimate the association between total annual costs and various patient variables.There were 52,782 IBD patients (29,062 UC; 23,720 CD) included in the analysis (54.1% females). On a per-annual basis, patients with IBD incurred a greater than 3-fold higher direct cost of care compared with non-IBD controls ($22,987 vs $6956 per-member per-year paid claims) and more than twice the out-of-pocket costs ($2213 vs $979 per-year reported costs), with all-cause IBD costs rising after 2013. Patients with IBD also experienced significantly higher costs associated with time spent on health care as compared with controls. The burden of costs was most notable in the first year after initial IBD diagnosis (mean = $26,555). The study identified several key drivers of cost for IBD patients: treatment with specific therapeutics (biologics, opioids, or steroids); ED use; and health care services associated with relapsing disease, anemia, or mental health comorbidity.The costs of care for IBD have increased in the last 5 years and are driven by specific therapeutics and disease features. In addition, compared with non-IBD controls, IBD patients are increasingly incurring higher costs associated with health care utilization, out-of-pocket expenditures, and workplace productivity losses. There is a pressing need for cost-effective strategies to address these burdens on patients and families affected by IBD. more...

Background Suicidal ideation (SI) is understudied in inflammatory bowel diseases (IBD). We aim to determine SI rates among IBD outpatients and to evaluate predictors of SI. Materials and methods This is a prospective observational study of consecutive adult IBD outpatients over 18 months. Patients were screened for depression and SI using patient health questionnaire (PHQ-9). Demographic data were obtained from electronic medical record. Regression modeling was used for predictor analyses. Results In total, 71 of consecutive 1352 IBD outpatients had SI. Significant correlations between SI and depression severity, tricyclic antidepressants (TCA), IBD-related quality of life, and low vitamin D levels were seen. Univariate regression showed that depression severity, TCA use, and quality of life predicted SI. Multivariate regression showed depression severity (β=0.46; P=0.002) and TCA use (β=0.31; P=0.012) made unique contributions. Conclusions SI is associated with depressive severity and less directly with IBD activity. Low-dose TCA, often used for chronic abdominal pain, is also a risk factor. Identifying the subset of IBD patients most vulnerable to SI can facilitate proper referrals to behavioral services and prevent progression to completed suicides. more...

Implementation of digital behavioral health programs in primary care (PC) can improve access to care for patients in need.This study provides preliminary data on user engagement and anxiety symptom change among patients referred by their PC provider to a guided, mobile cognitive behavioral program, Lantern.Adults aged 20-65 years with at least mild anxiety (GAD-7 ≥ 5) during routine clinical screening in two PC practices were offered Lantern. The primary outcome was self-reported anxiety collected at baseline and 2 months. Linear mixed effects modeling was used to examine anxiety symptom reduction from baseline to 2 months. Post hoc analyses evaluated how number of units completed, number of techniques practiced, and days of usage impacted symptom change.Sixty-three participants signed up for Lantern and had both baseline and 2- month GAD-7. A mixed effects model adjusted for age, gender, medical complexity score, and physical health found a significant effect of time on GAD-7 (β = -2.08, standard error = 0.77, t(62) = -2.71, p = 0.009). Post hoc analyses indicated that mean number of units, techniques, and usage days did not significantly impact GAD-7 change over 2 months. However, there was significantly greater improvement in anxiety in participants who completed at least three techniques.Results benchmark to previous studies that have found statistically significant symptom change among participants after 4-9 weeks of face-to-face or Internet-based cognitive behavioral therapy (CBT).This study suggests that use of Lantern is associated with anxiety reduction and provides proof-of-concept for the dissemination and implementation of guided, CBT-based mobile behavioral health interventions in PC settings. more...

How the gastrointestinal (GI) tract can influence the development and functioning of the central nervous system is one of the hottest translational research topics today. In animal studies, GI infections have been linked to enteric inflammation, disrupted intestinal permeability, and changes in diversity in the gut microbiome as well as brain dysfunction.1 In humans, infectious gastroenteritis has been associated with modified composition of the gut microbiome and systemic inflammation.2 Although gastroenteritis has not been causally linked to dysregulation of the brain in humans, it has been associated with later chronic GI conditions such as irritable bowel syndrome, which is often accompanied by anxiety and depression.2-4 In other human studies, microbiome dysbiosis has been associated with significantly increased the risk for later systemic inflammation and brain dysfunction manifested as changes in emotions, behaviors, pain perception, and cognitions.5,6 Most studies investigating these relationships have focused on adult cohorts and are often cross-sectional in design nature. The study by Parent et al.7 is the first longitudinal study to evaluate whether repeated episodes of gastroenteritis during early childhood predicts behavioral problems in later childhood and mental illness during adolescence. In addition, it has an exploratory mechanistic objective: whether systemic inflammation in later childhood and adolescence moderates this brain-gut relationship. more...

Opioids were one of the earliest classes of medications used for pain across a variety of conditions, but morbidity and mortality have been increasingly associated with their chronic use. Despite these negative consequences, chronic opioid use is increasing worldwide, with the USA and Canada having the highest rates. Chronic opioid use for noncancer pain can have particularly negative effects in the gastrointestinal and central nervous systems, including opioid-induced constipation, narcotic bowel syndrome, worsening psychopathology and addiction. This Review summarizes the evidence of opioid misuse in gastroenterology, including the lack of evidence of a benefit from these drugs, as well as the risk of harm and negative consequences of opioid use relative to the brain-gut axis. Guidelines for opioid management and alternative pharmacological and nonpharmacological strategies for pain management in patients with gastrointestinal disorders are also discussed. As chronic pain is complex and involves emotional and social factors, a multimodal approach targeting both pain intensity and quality of life is best. more...

This review focuses on the relationship between trauma and pain in inflammatory bowel disease (IBD), and offers effective treatment strategies. Recent evidence points to bidirectional pathways between psychiatric disorders and IBD. The impact of trauma and development of post-traumatic stress symptoms on IBD disease course is beginning to be appreciated including its relationship with pain. First-line treatments for both psychiatric and chronic pain disorders include behavioral interventions such as cognitive behavioral therapy, hypnosis, and mindfulness, and there is emerging evidence studying Acceptance and Commitment Therapy and telehealth interventions. Pharmacological treatments using neuromodulators can also be beneficial. An integrated care team, such as a subspecialty medical home model, can provide the best patient experience and address comprehensive care needs efficiently and effectively. Psychosocial factors impact IBD course and necessitate effective management. Despite the significant limitations of research, particularly lack of clinical trials examining behavioral and pharmacotherapy interventions in IBD, effective treatments exist and are best utilized in an integrated care setting. more...

Gastrointestinal (GI) pain - a form of visceral pain - is common in some disorders, such as irritable bowel syndrome, Crohn's disease and pancreatitis. However, identifying the cause of GI pain frequently represents a diagnostic challenge as the clinical presentation is often blurred by concomitant autonomic and somatic symptoms. In addition, GI pain can be nociceptive, neuropathic and associated with cancer, but in many cases multiple aetiologies coexist in an individual patient. Mechanisms of GI pain are complex and include both peripheral and central sensitization and the involvement of the autonomic nervous system, which has a role in generating the symptoms that frequently accompany pain. Treatment of GI pain depends on the precise type of pain and the primary disorder in the patient but can include, for example, pharmacological therapy, cognitive behavioural therapies, invasive surgical procedures, endoscopic procedures and lifestyle alterations. Owing to the major differences between organ involvement, disease mechanisms and individual factors, treatment always needs to be personalized and some data suggest that phenotyping and subsequent individual management of GI pain might be options in the future. more...

Gastrointestinal (GI) pain - a form of visceral pain - is common in some disorders, such as irritable bowel syndrome, Crohn's disease and pancreatitis. However, identifying the cause of GI pain frequently represents a diagnostic challenge as the clinical presentation is often blurred by concomitant autonomic and somatic symptoms. In addition, GI pain can be nociceptive, neuropathic and associated with cancer, but in many cases multiple aetiologies coexist in an individual patient. Mechanisms of GI pain are complex and include both peripheral and central sensitization and the involvement of the autonomic nervous system, which has a role in generating the symptoms that frequently accompany pain. Treatment of GI pain depends on the precise type of pain and the primary disorder in the patient but can include, for example, pharmacological therapy, cognitive behavioural therapies, invasive surgical procedures, endoscopic procedures and lifestyle alterations. Owing to the major differences between organ involvement, disease mechanisms and individual factors, treatment always needs to be personalized and some data suggest that phenotyping and subsequent individual management of GI pain might be options in the future. more...

Introduction Sleep continuously changes over the human lifespan and it does so across multiple dimensions, including duration, timing, efficiency, and variability. Although studies focused on specific developmental periods have shown age-related changes in sleep, methodological differences make it difficult to synthesize information across studies to fully understand precisely when these sleep changes occur. Our goal was to use individual-level actigraphy and self-report sleep data from a single site to characterize age trends and sex differences in actigraphy and self-report sleep dimensions across the healthy human lifespan. To accomplish this goal, we developed the Pittsburgh Lifespan Sleep Databank (PLSD), a large aggregate databank of participants from sleep research studies conducted at the University of Pittsburgh. Methods In the present analysis, we included N=1,070 PLSD participants from 21 studies without a major psychiatric, sleep, or medical condition. We used Generalized Additive Models to examine flexible, potentially non-linear relationships between age and sleep dimensions (actigraphy and self-report duration, efficiency, and timing; actigraphy variability) from ages 10 to 87. We also examined whether these sleep characteristics differed by sex across the lifespan. Results The most dramatic age-related trends were observed in sleep timing. Actigraphy and self-report sleep onset time shifted later between ages 10–18 and then shifted earlier again during the 20s. Actigraphy and self-report wake-up time also shifted earlier during the mid-20s through late 30s. Self-report duration became shorter from approximately ages 10–20. Self-report sleep efficiency and actigraphy variability both decreased over the entire lifespan. Relative to males, females tended to have earlier self-report sleep onset, higher actigraphy sleep efficiency, and longer actigraphy duration. Conclusion By focusing on lifespan sleep rather than specific age segments of the samples, we can provide a unified assessment of age-related changes and sex differences from childhood through older adulthood. An understanding of age trends and sex differences in sleep in healthy individuals – and explicating the timing and nature of these difference – can be used to identify periods of sleep-related risk or resilience and guide intervention efforts. Support (if any) University of Pittsburgh Clinical and Translational Science Institute (UL1TR001857). more...

Introduction Patients with FGIDs suffer from anxiety and depression and exhibit increased sensitivity to stressors. Cognitive behavioral therapy (CBT) is known to help improve mood, increase stress resiliency, and reduces FGID symptom severity but faces substantial barriers to implementation. Integrating behavioral health technology into medical clinic workflows could overcome these barriers. We evaluated the feasibility and initial impact of a digital CBT (dCBT) tool as a lower-barrier, first-line intervention for reducing emotional distress in FGID patients. Methods Patients seen at an integrated behavioral-neurogastroenterology clinic exhibiting or reporting symptoms of anxiety and/or depression during their encounter (in-person or telemedicine visit between March 1-Oct 31, 2020) were offered access to a dCBT app called RxWell, which consists of 40 CBT techniques and is supported by digital health coaches who communicate with patients via within-app texts. Patients completed anxiety (GAD7) and depression (PHQ8) measures at the baseline visit and monthly via the app. The study outcomes include changes in GAD7 and PHQ8 scores over a 3-month period. The app prescription was used as first line behavioral intervention, and was supplemented by sessions with behavioral providers, as clinically indicated. Results RxWell was e-prescribed during ~17% of all patient visits during the study period (77% by GI providers). Of the 298 FGID patients (mean age 43 yrs [sd 16 yrs]; 73.2% women; Table 1) who were prescribed RxWell, 54% downloaded the app and completed more than 3 dCBT techniques (mean number 15 [sd 28]). Further, 43% of RxWell users communicated with their digital health coaches. About 25% of the cohort met with a behavioral therapist, and of these, 16% met with a psychiatrist. Mean baseline GAD7 scores (11.6 [sd 5.5]) and PHQ8 scores (11.2 [sd 6]) indicated moderate severity. There was a significant improvement in GAD7 (mean change 3.7 [t 5.1, df 47; p Conclusion We demonstrate the feasibility of implementing dCBT in the care of FGID patients with moderate anxiety and depressive symptom scores. The use of the dCBT app is associated with clinically and statistically significant mood symptom reductions within 3 months, and supplementation with digital health coaching further enhanced these benefits. These preliminary results suggest that dCBT is a viable strategy to improve FGID patient access to effective behavioral therapy. Download : Download high-res image (72KB) Download : Download full-size image Table 1 . FGID diagnoses within our population. Download : Download high-res image (71KB) Download : Download full-size image Table 2 . Difference between baseline and follow up scores for patients using dCBT. more...

New models of health care have emerged over the past decade. Accountable care organizations and patient-centered medical homes are designed to improve the patient experience, enhance health care quality, and decrease cost. These models have been developed in the primary care domain and have yet to be tested in specialty care. Certain chronic diseases require principal care by a specialist or health care team. The specialty medical home would provide patient-centered care for specific populations of patients whose health care derives from a single chronic disease. This article defines the parameters for a specialty medical home and provides a specific payer-provider experience for the comprehensive care of an inflammatory bowel disease population. more...