AGA Clinical Practice Update on Pain Management in Inflammatory Bowel Disease: Commentary.

DESCRIPTION: Pain is a common symptom among patients with inflammatory bowel disease (IBD). Although pain typically occurs during episodes of inflammation, it is also commonly experienced when intestinal inflammation is quiescent. Many gastroenterologists are at a loss how to approach pain symptoms when they occur in the absence of gut inflammation. We provide guidance in this area as to the evaluation, diagnosis, and treatment of pain among patients with IBD. METHODS: This CPU was commissioned and approved by the AGA Institute Clinical Practice Updates Committee (CPUC) and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership and underwent internal peer review by the CPUC and external peer review through standard procedures of Gastroenterology. This expert commentary incorporates important as well as recently published studies in this field, and it reflects the experiences of the authors. Formal ratings regarding the quality of evidence or strength of the presented considerations were not included because systematic reviews were not performed.

Subphenotypes of self-reported symptoms and outcomes in long COVID: a prospective cohort study with latent class analysis.

OBJECTIVE: To characterise subphenotypes of self-reported symptoms and outcomes (SRSOs) in postacute sequelae of COVID-19 (PASC). DESIGN: Prospective, observational cohort study of subjects with PASC. SETTING: Academic tertiary centre from five clinical referral sources. PARTICIPANTS: Adults with COVID-19 ≥20 days before enrolment and presence of any new self-reported symptoms following COVID-19. EXPOSURES: We collected data on clinical variables and SRSOs via structured telephone interviews and performed standardised assessments with validated clinical numerical scales to capture psychological symptoms, neurocognitive functioning and cardiopulmonary function. We collected saliva and stool samples for quantification of SARS-CoV-2 RNA via quantitative PCR. OUTCOMES MEASURES: Description of PASC SRSOs burden and duration, derivation of distinct PASC subphenotypes via latent class analysis (LCA) and relationship with viral load. RESULTS: We analysed baseline data for 214 individuals with a study visit at a median of 197.5 days after COVID-19 diagnosis. Participants reported ever having a median of 9/16 symptoms (IQR 6-11) after acute COVID-19, with muscle-aches, dyspnoea and headache being the most common. Fatigue, cognitive impairment and dyspnoea were experienced for a longer time. Participants had a lower burden of active symptoms (median 3 (1-6)) than those ever experienced (p<0.001). Unsupervised LCA of symptoms revealed three clinically active PASC subphenotypes: a high burden constitutional symptoms (21.9%), a persistent loss/change of smell and taste (20.6%) and a minimal residual symptoms subphenotype (57.5%). Subphenotype assignments were strongly associated with self-assessments of global health, recovery and PASC impact on employment (p<0.001) as well as referral source for enrolment. Viral persistence (5.6% saliva and 1% stool samples positive) did not explain SRSOs or subphenotypes. CONCLUSIONS: We identified three distinct PASC subphenotypes. We highlight that although most symptoms progressively resolve, specific PASC subpopulations are impacted by either high burden of constitutional symptoms or persistent olfactory/gustatory dysfunction, requiring prospective identification and targeted preventive or therapeutic interventions.

SuRxgWell: study protocol for a randomized controlled trial of telemedicine-based digital cognitive behavioral intervention for high anxiety and depression among patients undergoing elective hip and knee arthroplasty surgery.

BACKGROUND: Mood disorders (anxiety, depression), sleep disorders, and catastrophizing lead to increased post-operative pain perception, increase in postoperative opioid consumption, decreased engagement with physical activity, and increased resource utilization in surgical patients. Psychosocial disorders significantly affect postoperative outcome. Unfortunately, studies focused on perioperative psychological assessment and treatment are scarce. We propose to test whether digital cognitive behavioral intervention (dCBI) can help surgical patients. dCBI such as RxWell™ is a proven treatment for mood disorders in medical patients such as reducing depression in patients with inflammatory bowel disease. We hypothesize that RxWell™ will also be effective in surgical patients. This study aims to test whether RxWell™ can improve preoperative mood disorders and subsequently reduce postoperative pain and opioid requirement in patients scheduled for primary total hip and knee arthroplasty (THA, TKA). We named the trial as the SuRxgWell trial. METHODS: This is a randomized, controlled trial that will enroll primary and unilateral THA or TKA patients with anxiety and/or depression symptoms before surgery to receive the SuRxgWell dCBI program and investigate its impact on postoperative outcomes including postoperative pain, anxiety, depression, sleep disorder, and catastrophizing. After signing an informed consent, subjects will be screened using the PROMIS questionnaires, and subjects with a T-score of ≥ 60 on the short Patient-Reported Outcomes Measurement Information System (PROMIS) 4a Anxiety and/or short PROMIS 4a Depression questionnaires will be randomized to either usual care (control group) or the cognitive behavioral intervention, RxWell™, plus usual care (intervention group). The control group will receive information on how to locate tools to address anxiety and depression, whereas the intervention group will have access to SuRxgWell 1 month prior to surgery and up to 3 months after surgery. The allocation will be 3:1 (intervention to control). Investigators will be blinded, but research coordinators approaching patients and research subjects will not. The primary outcome will be day of surgery anxiety or depression symptoms measured with the PROMIS Short Form v1.0 -Anxiety 4a/Depression and Generalized Anxiety Disorder Measure (GAD-7) and Patient Health Questionnaire (PHQ-8). Secondary end points include measuring other health-related quality of life outcomes including sleep disturbance, fatigue, ability to participate in social roles, pain interference, cognitive function, pain catastrophizing, and physical function. Other secondary outcomes include collecting data about preoperative and postoperative pain scores, and pain medication usage, and orthopedic functional recovery at baseline, day of surgery, and 1, 2, and 3 months after the surgery with the Pain Catastrophizing Scale, the Knee injury and Osteoarthritis Outcome Score (KOOS), and Hip injury and Osteoarthritis Outcome Score (HOOS). In addition, subjects will be asked to complete a GAD-7 and PHQ-8 questionnaires bi-weekly (via the RxWell™ app for the interventional group or REDCAP for the control group). Data about postsurgical complications, and resource utilization will also be recorded. We will also receive monthly reports measuring the usage and engagement of RxWell use for each participant randomized to that arm. The primary hypotheses will be assessed with intention-to-treat estimates, and differences in primary outcome will be tested using independent two sample t-tests. This trial is registered to the ClinicalTrials.gov database (NCT05658796) and supported by the DAPM, UPMC Health Plan, and the NIH. DISCUSSION: Our trial will evaluate the feasibility of digital cognitive behavioral intervention as a perioperative tool to improve anxiety and depression before and after major orthopedic surgery in comparison to education. If digital cognitive behavioral intervention proves to be effective, this might have important clinical implications, reducing the incidence of chronic postsurgical pain and improving outcomes.

Perceptions of and Experiences with the COVID-19 Pandemic Among Individuals with Inflammatory Bowel Disease.

The COVID-19 pandemic resulted in increased feelings of emotional distress and disruptions in care across diverse patients subgroups, including those with chronic medical conditions such as inflammatory bowel diseases (IBD). We sought to understand the impact of the pandemic on the physical and emotional well-being of individuals with IBD and concurrent depression and/or anxiety symptoms. We conducted qualitative interviews after the beginning of the pandemic with 46 adults with IBD. Participants reported increased levels of emotional distress, feelings of social isolation, and uncertainty over whether IBD medications put them at increased risk. Young adults discussed feeling as if their lives had been disrupted. In addition, several individuals demonstrated resiliency and emphasized positives about the pandemic, including increased connectivity with family and friends, the convenience of being able to work from home despite their IBD symptoms, and lessened feelings of "missing out." Our findings highlight several opportunities to improve the health and well-being of individuals with IBD and beyond including increased support for combatting social isolation, enhanced counseling about medication risks and benefits, and the incorporation of resiliency skills building.

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

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

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

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

Efficacy of a digital mental health intervention embedded in routine care compared with treatment as usual in adolescents and young adults with moderate depressive symptoms: protocol for randomised controlled trial.

INTRODUCTION: There are unmet mental health needs of depressed adolescents and young adults (AYAs) across the USA. Behavioural technology adequately integrated into clinical care delivery has potential to improve care access and efficiency. This multisite randomised controlled trial evaluates how a coach-enhanced digital cognitive behavioural intervention (dCBI) enhances usual care for depressed AYAs in paediatric practices with minority enriched samples. METHODS AND ANALYSIS: Participants (n=750) ages 16-22 who meet threshold criteria for depressive severity (Patient Health Questionnaire-9; PHQ-9 score 10-24) will be recruited through paediatric practices across three academic institutions (Boston, Pittsburgh and San Diego). Participants will be randomised to 12 weeks of dCBI+treatment as usual (TAU) (n=450) or TAU alone (n=300) in outpatient paediatric practices. Assessments will be completed at baseline, 6 weeks and 12 weeks with the primary outcome being improvement in clinician-rated and self-reported depressive severity (Children's Depression Rating Scale-Revised and PHQ-9) and secondary outcomes being self-reported suicidal ideation (item 9 on PHQ-9), anxiety severity (Generalised Anxiety Disorder), general quality of life (Satisfaction with Life Scale) and general functioning (Children's Global Assessment Scale). The study design is an intent-to-treat mixed effects regression with group, and covariates nested within the sites. ETHICS AND DISSEMINATION: All participants or their parent/guardian (under 18 years or unemancipated) will give informed consent to a study team member. All data are expected to be collected over 18 months. The Institutional Review Board (IRB) is a board at each institution in the United States that reviews and monitors research involving human subjects. IRB approval from the University of Pittsburgh was obtained on 30 November 2021 (STUDY21080150), from the University of California San Diego's Human Research Protection Program IRB on 14 July 2022 (802047), and from the Boston Children's Hospital IRB on 25 October 2022 (P00040987). Full study results are planned to be published within 2 years of initial study recruitment (October 2024). Dissemination of findings will occur in peer-reviewed journals, professional conferences and through reports to participating entities and stakeholders. TRIAL REGISTRATION NUMBER: NCT05159713; ClinicalTrials.gov.

A Digital Cognitive-Behavioral Intervention for Depression and Anxiety Among Adolescents and Young Adults.

Adolescents and young adults frequently experience anxiety and depression. The authors evaluated engagement in and effects of a coach-enhanced digital cognitive-behavioral intervention (dCBI; RxWell) targeting emotional distress in this age group. The dCBI app was prescribed to 506 adolescents and young adults at 35 pediatric practices; 278 enrolled in the app, of whom 58% engaged and 63% messaged their coach. Patients completed monthly General Anxiety Disorder-7 and eight-item Patient Health Questionnaire assessments, and a subset completed qualitative interviews. The dCBI app was associated with a significant reduction in anxiety and depression at 1 and 3 months. A dCBI is feasible as part of routine pediatric care and associated with reduced emotional distress.

Behavioral Digital Therapeutics in Gastrointestinal Conditions: Where Are We Now and Where Should We Go?

Behavioral digital therapeutics represents a diverse range of health technology tools that can offer beneficial options for patients with gastrointestinal disorders, particularly with the shortage of mental health providers. Challenges to the uptake of behavioral digital interventions exist and can be addressed with mobile device applications, improved interoperability of technology platforms, and flexible integration into clinical practice.

Strengthening the Impact of Digital Cognitive Behavioral Interventions Through a Dual Intervention: Proficient Motivational Interviewing-Based Health Coaching Plus In-Application Techniques.

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 (P<.001); (2) DHCs with a demonstrated competency in applying MI to digital messages had more engaged users, as measured by the DHC-to-user message exchange ratio (P<.001); (3) the DHC-to-user message exchange ratio was correlated with more engagement in app activities (r=0.28, 95% CI 0.23-0.33); (4) DHCs with demonstrated MI proficiency elicited a greater amount of "change talk" from users than did DHCs without MI proficiency (H=25.12, P<.001); and (5) users who were engaged by DHCs with MI proficiency had better clinical outcomes compared to users engaged by DHCs without MI proficiency (P=.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.

Age Trends in Actigraphy and Self-Report Sleep Across the Life Span: Findings From the Pittsburgh Lifespan Sleep Databank.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

High Sugar-Sweetened Beverage Consumption Is Associated with Increased Health Care Utilization in Patients with Inflammatory Bowel Disease: A Multiyear, Prospective Analysis.

BACKGROUND: 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. OBJECTIVE: 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? DESIGN: 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. PARTICIPANTS/SETTING: 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 as > 2 but < 7 SSBs per week. Low SSB consumption was defined as 2 or fewer SSBs per week. MAIN OUTCOME MEASURES: 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. STATISTICAL ANALYSIS PERFORMED: 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). CONCLUSIONS: 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.

Brief Behavioral Therapy and Bupropion for Sleep and Fatigue in Young Adults With Crohn's Disease: An Exploratory Open Trial Study.

BACKGROUND/AIMS: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Editorial: Transition to Telehealth for Mental Health Clinics: Future Considerations.

The acute mental health demands during the COVID-19 pandemic galvanized early adoption of telehealth for care delivery in all medical settings. This is even more so for the field of psychiatry.1 Whether an established telehealth program existed or not, the abrupt lifting of regulations and urgent need for access to care opened the telehealth flood gates. While video visits and telephone visits improved immediate access to care, they simultaneously challenged our ability to structure, organize, educate, operationalize, and track such visits.1 This swift shift in health care delivery forced providers, health care systems, and patients into a nationwide experiment to learn what works well via telehealth and what does not. The ground-breaking article by Folk et al.2 focuses on challenges and successes for a new shared phenomenon: the sudden pivot from in-person to video/telephone care. We examine the data collected by this consortium and compare it with our own experience at UPMC Western Psychiatric behavioral health outpatient settings, both academic and rural.

A Coached Digital Cognitive Behavioral Intervention Reduces Anxiety and Depression in Adults With Functional Gastrointestinal Disorders.

INTRODUCTION: Traditional cognitive behavioral interventions (CBIs) improve mood and gastrointestinal symptom severity in patients with functional gastrointestinal disorders (FGIDs) but face substantial barriers to implementation. Integrating behavioral health technology into medical clinic workflows could overcome these barriers. We evaluated the feasibility and impact of a coached digital CBI (dCBI) as a first-line intervention in a prospective cohort of emotionally distressed patients with FGID. METHODS: Patients with anxiety and/or depressive symptoms were offered a dCBI (an app called RxWell) during routine clinic visits. RxWell provides cognitive behavioral techniques enhanced by within-app text messaging with a health coach. Both gastroenterology and behavioral health-care providers electronically prescribed RxWell. We tracked patient interactions with RxWell, and patients completed anxiety (General Anxiety Disorder-7) and depression (Personal Health Questionniare Depression Scale) measures through the app. Our primary study outcome was the change in General Anxiety Disorder-7 and Personal Health Questionniare Depression Scale scores. RESULTS: Of 364 patients with FGID (mean age 43 years [SD 16 years]; 73.1% women) prescribed the dCBI, 48.4% enrolled (median use, 3 techniques [interquartile range 1-14]). About half of RxWell enrollees communicated with health coaches. The mean baseline anxiety score was 11.4 (SD 5.5), and the depression score was 11.5 (SD 6.1). RxWell users experienced improvements in anxiety (mean change 2.71 [t = 3.7, df = 58; P < 0.001]) and depression (mean change 2.9 [t = 4.2, df = 45; P < 0.001]) at 4 months. DISCUSSION: Patients with FGIDs and moderately severe anxiety and depressive symptoms are willing to use dCBI tools recommended by their providers. Our pilot data demonstrate that dCBI usage is associated with clinically and statistically significant mood symptom reductions.

Health Care Provider Perspectives on the Use of a Digital Behavioral Health App to Support Patients: Qualitative Study.

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.

A Blueprint for the Conduct of Large, Multisite Trials in Telemedicine.

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.

Editors' Note and Special Communication: Research Priorities in Child and Adolescent Mental Health Emerging From the COVID-19 Pandemic.

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 adolescents3,5,7-10 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' Note1 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.

Opioid Use Associated With Higher Costs Among Patients With Inflammatory Bowel Disease.

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.