Distilling the Fundamentals of Evidence-Based Public Health Policy.

Public health policy interventions are associated with many important public health achievements. To provide public health practitioners and decision makers with practical approaches for examining and employing evidence-based public health (EBPH) policy interventions, we describe the characteristics and benefits that distinguish EBPH policy interventions from programmatic interventions. These characteristics include focusing on health at a population level, focusing on upstream drivers of health, and involving less individual action than programmatic interventions. The benefits of EBPH policy interventions include more sustained effects on health than many programs and an enhanced ability to address health inequities. Early childhood education and universal preschool provide a case example that illustrates the distinction between EBPH policy and programmatic interventions. This review serves as the foundation for 3 concepts that support the effective use of public health policy interventions: applying core component thinking to understand the population health effects of EBPH policy interventions; understanding the influence of existing policies, policy supports, and the context in which a particular policy is implemented on the effectiveness of that policy; and employing a systems thinking approach to identify leverage points where policy implementation can have a meaningful effect.

Pacemaker lead thrombosis - a rare cause of breathlessness.

As the number of pacemaker insertions increases to manage numerous cardiac arrhythmias, the number of complications is also increasing as a result. More common complications such as infection and lead displacement are routinely discussed with patients before they undergo the procedure. However rare complications such as superior vena cava syndrome are not discussed during the consenting period. But they do occur, as seen in this case of a 69-year-old male. This fit and active man had a right-sided dual-chamber pacemaker inserted due to sinus node disease and presented 5 years later with symptoms suggestive of superior vena cava obstruction (SVCO). Despite anticoagulation and before surgical intervention could be performed, the patient developed a right-sided chylothorax which was drained. An autologous pericardial patch repair of the SVC and a thrombectomy of SVC clots was subsequently performed. This was only partially successful and the SVCO recurred. A low fatty chain diet was initiated to manage the chylothorax, which remains stable. This rare complication has left the patient with a small pleural effusion and chronic pleural thickening. They can still exercise with mild breathlessness. The management of such a complication, which requires the input of many specialists, is challenging and often does not completely resolve all symptoms. For this reason, superior vena cava obstruction should be considered as a risk during the consenting procedure for a pacemaker insertion.

Advancing Evidence-Based Public Health Policy: How Core Component Thinking Can Illuminate the Multilevel Nature of Public Health Policy.

A growing body of literature uses the concept of core components to better understand small-scale programmatic interventions. Instead of interventions being viewed as unitary "black boxes," interventions are viewed as configurations of core components, which are the parts of interventions that carry their causal potential and therefore need to be reproduced with fidelity to produce the intended effect. To date, the concept of core components has not been as widely applied to public health policy interventions as it has to programmatic interventions. The purpose of this topical review is to familiarize public health practitioners and policy makers with the concept of core components as applied to public health policy interventions. Raising the profile of core component thinking can foster mindful adaptation and implementation of public health policy interventions while encouraging further research to enhance the supporting evidence base. We present 3 types of multilevel interactions in which the core components of a public health policy intervention produce effects at the population level by (1) seeking to directly affect individual behavior, (2) facilitating adoption of programmatic interventions by intermediaries, and (3) encouraging intermediaries to take action that can shape changes in upstream drivers of population health. Changing the unit of analysis from whole policies to core components can provide a basis for understanding how policies work and for facilitating novel evidence-generating strategies and rapid evidence reviews that can inform future adaptation efforts.

COVID-19 lockdowns affected birthing outcomes in a regional New South Wales Health District.

INTRODUCTION: The 400 000 residents of the Illawarra Shoalhaven Local Health District (ISLHD) experienced two distinct lockdowns aimed at mitigating the transmission of severe acute respiratory syndrome coronavirus 2 infection. Analysing effects of these lockdowns on maternal and neonatal outcomes presents a valuable opportunity to assess the impact of pandemic-level restrictions on maternal and neonatal outcomes. AIM: Evaluate the impacts of restrictions from two lockdown periods on maternal, birthing, and neonatal outcomes within a regional local health district. MATERIALS AND METHODS: The study included 22 166 women who gave birth within ISLHD between 2017 and 2022. Groups included for analysis: Control Group - mothers pregnant before the pandemic (conception before 3 April 2019); Exposure Group 1 - mothers pregnant during the first lockdown (conception date 22 January 2020 to 5 May 2020); and Exposure Group 2 - mothers pregnant during the second lockdown (conception date 30 April 2021 to 13 Sep 2021). RESULTS: Odds of adverse birthing outcomes including non-reassuring fetal status (odds ratio (OR) 1.34; 95% CI 1.14-1.56 and OR 1.20; 95% CI 1.03-1.40), and postpartum haemorrhage (OR 2.04; 95% CI 1.73-2.41 and OR 1.74; 95% CI 1.48-2.05) were substantially increased in Exposure Groups 1 and 2, respectively. Gestational diabetes, gestational hypertension, low birth weight and admission to neonatal intensive care rates improved. CONCLUSIONS: Pregnant women exposed to pandemic restrictions within ISLHD had decreased odds of adverse antenatal and neonatal outcomes, but increased odds of poor peripartum outcomes.

Cognitive processing therapy (CPT) versus individual drug counseling (IDC) for PTSD for veterans with opioid use disorder maintained on buprenorphine.

BACKGROUND AND OBJECTIVES: There are high rates of comorbidity between posttraumatic stress disorder (PTSD) and opioid use disorder (OUD). Evidence-based trauma-focused psychotherapies such as Cognitive Processing Therapy (CPT) are a first-line treatment for PTSD. Veterans with OUD are treated primarily in substance use disorder (SUD) clinics where the standard of care is drug counseling; they often do not have access to first-line PTSD treatments. This study tested whether CPT can be conducted safely and effectively in veterans with comorbid OUD treated with buprenorphine. METHODS: This 12-week, 2-site, randomized clinical trial (RCT) included open-label randomization to two groups: (a) CPT versus (b) Individual Drug Counselling (IDC) in veterans with PTSD and comorbid OUD who were maintained on buprenorphine (N = 38). RESULTS: Veterans randomized to either IDC (n = 18) or CPT (n = 20) showed a significant reduction in self-reported PTSD symptoms over time as measured by the PTSD checklist (PCL-5) but there were no treatment group differences; there was some indication that reduction in PTSD symptoms in the CPT group were sustained in contrast to the IDC group. Recruitment was significantly impacted by COVID-19 pandemic, so this study serves as a proof-of-concept pilot study. DISCUSSION AND CONCLUSIONS: Veterans with OUD and PTSD can safely and effectively participate in evidence-based therapy for PTSD; further work should confirm that trauma-focused treatment may be more effective in leading to sustained remission of PTSD symptoms than drug counseling. SCIENTIFIC SIGNIFICANCE: This is the first study to evaluate CPT for PTSD in the context of buprenorphine treatment for OUD.

Why step in? Shifting justifications for bystander behaviors through interventions with youth in the Middle East.

Research shows positive bystander intervention effectively mitigates bullying experiences. Yet, more evidence regarding bystander responses to bias-based social exclusion (BSE) is needed in intergroup contexts, especially in the majority world and in areas of intractable conflict. This study assessed the effectiveness of skills and skills + contact-based interventions for BSE among 148 Palestinian Citizens of Israel (Mage = 10.55) and 154 Jewish-Israeli (Mage = 10.54) early adolescents (Girls = 52.32%) in Tel Aviv-Yafo. Bystander responses were assessed by participants' reactions to hypothetical BSE scenarios over three time points. Repeated measures ANOVAs revealed both interventions significantly increased positive and decreased negative bystander responses, with changes maintained at the follow-up. The opposite result pattern emerged for the control group. Findings suggest that both interventions can effectively encourage youth to publicly challenge BSE, even amidst intractable conflict.

Electrochemical Synthesis of Sound: Hearing the Electrochemical Double Layer.

Electrochemical double layers (EDLs) govern the operation of batteries, fuel cells, electrochemical sensors, and electrolyzers. However, their invisible nature makes their properties and function difficult to conceptualize, creating an impediment to the broader understanding of double-layer function required for future technologies in energy storage and chemical synthesis. To render the behavior of electrochemical interfaces more intuitive, we made the rearrangement of interfacial components audible by employing the EDL as a variable element in a relaxation oscillator circuit. Connecting the circuit to a speaker generated an audible output corresponding to the change in potential resulting from EDL rearrangement. Variations in the applied voltage, electrolyte concentration and identity, as well as in the electrode material, yielded audible frequency variations that provide an intuitive understanding of EDL behavior. We expect that hearing the trends in behavior will provide a helpful and alternative method for understanding molecular movement at the electrochemical interface.

Productions Need Not Match Study Items to Confer a Production Advantage, But It Helps.

The production effect is the finding that, relative to silent reading, producing information at study (e.g., reading aloud) leads to a benefit in memory. In most studies of this effect, individuals are presented with a set of unique items, and they produce a subset of these items (e.g., they are presented with the to-be-remembered target item TABLE and produce table) such that the production is both unique and representative of the target. Across two preregistered experiments, we examined the influence of a production that is unique but that does not match the target (e.g., producing fence to the target TABLE, producing car to the target TREE, and so on). This kind of production also yielded a significant effect-the mismatching production effect-although it was smaller than the standard production effect (i.e., when productions are both unique and representative of their targets) and was detectable only when targets with standard productions were included in the same study phase (i.e., when the type of production was manipulated within participant). We suggest that target-production matching is an important precursor to the production effect and that the kind of production that brings about a benefit depends on the other productions that are present.

The prod eff: Partially producing items moderates the production effect.

Current accounts of the production effect suggest that production leads to the encoding of additional production-associated features and/or better feature encoding. Thus, if it is the act of production that leads to the storage and/or enhanced encoding of these features, then less of this act should reduce the resulting production effect. In two experiments, we provide a direct test of this idea by manipulating how much of a given item is produced within a single mode of production (typing). Results demonstrate that such partial production can yield a significant production effect that is smaller than the effect that emerges from producing the entire item. These results suggest that how much of an item is produced can moderate the size of the production effect and are considered in the context of recent modelling efforts.

Domains of Excellence: A CDC Framework for Developing High-Quality, Impact-Driven Public Health Science Publications.

CONTEXT: The Centers for Disease Control and Prevention (CDC) has a long history of using high-quality science to drive public health action that has improved the health, safety, and well-being of people in the United States and globally. To ensure scientific quality, manuscripts authored by CDC staff are required to undergo an internal review and approval process known as clearance. During 2022, CDC launched a scientific clearance transformation initiative to improve the efficiency of the clearance process while ensuring scientific quality. PROGRAM: As part of the scientific clearance transformation initiative, a group of senior scientists across CDC developed a framework called the Domains of Excellence for High-Quality Publications (DOE framework). The framework includes 7 areas ("domains") that authors can consider for developing high-quality and impactful scientific manuscripts: Clarity, Scientific Rigor, Public Health Relevance, Policy Content, Ethical Standards, Collaboration, and Health Equity. Each domain includes multiple quality elements, highlighting specific key considerations within. IMPLEMENTATION: CDC scientists are expected to use the DOE framework when conceptualizing, developing, revising, and reviewing scientific products to support collaboration and to ensure the quality and impact of their scientific manuscripts. DISCUSSION: The DOE framework sets expectations for a consistent standard for scientific manuscripts across CDC and promotes collaboration among authors, partners, and other subject matter experts. Many aspects have broad applicability to the public health field at large and might be relevant for others developing high-quality manuscripts in public health science. The framework can serve as a useful reference document for CDC authors and others in the public health community as they prepare scientific manuscripts for publication and dissemination.

A Narrative Review of Literature Examining Studies Researching the Impact of Law on Health and Economic Outcomes.

CONTEXT: Public health policy can play an important role in improving public health outcomes. Accordingly, there has been an increasing emphasis by policy makers on identifying and implementing evidence-informed public health policy interventions. PROGRAM OR POLICY: Growth and refinement of the field of research assessing the impact of legal interventions on health outcomes, known as legal epidemiology, prompted this review of studies on the relationship between laws and health or economic outcomes. IMPLEMENTATION: Authors systematically searched 8 major literature databases for all English language journal articles that assessed the effect of a law on health and economic outcomes published between January 1, 2009, and September 18, 2019. This search generated 12 570 unique articles 177 of which met inclusion criteria. The team conducting the systematic review was a multidisciplinary team that included health economists and public health policy researchers, as well as public health lawyers with expertise in legal epidemiological research methods. The authors identified and assessed the types of methods used to measure the laws' health impact. EVALUATION: In this review, the authors examine how legal epidemiological research methods have been described in the literature as well as trends among the studies. Overall, 3 major themes emerged from this study: (1) limited variability in the sources of the health data across the studies, (2) limited differences in the methodological approaches used to connect law to health outcomes, and (3) lack of transparency surrounding the source and quality of the legal data relied upon. DISCUSSION: Through highlighting public health law research methodologies, this systematic review may inform researchers, practitioners, and lawmakers on how to better examine and understand the impacts of legal interventions on health and economic outcomes. Findings may serve as a source of suggested practices in conducting legal epidemiological outcomes research and identifying conceptual and method-related gaps in the literature.

Prepubescent Electronic Cigarette Exposure Affects Sexual Motivation and Puberty in Female But Not Male Long-Evans Rats.

INTRODUCTION: A method for delivering vaporized nicotine to animals has been developed using e-cigarette devices. The present experiment was designed to measure the effects of e-cigarette nicotine on pubertal onset and development of reproductive behavior in female and male Long-Evans rats. AIM AND METHODS: Rats received daily 10-min sessions of electronic-cigarette vaporized nicotine (5% Virginia Tobacco JUUL Pods) or room air in a whole-body exposure chamber (postnatal day 28-31). Pubertal onset was monitored daily (ie, vaginal opening in females, preputial separation in males). Two weeks later, rats were tested for sexual motivation using the partner-preference paradigm, whereby subjects were given the opportunity to approach either a sexual partner or a same-sex social partner. Four weeks later, partner preference was assessed again, 10 min after rats were re-exposed to their same prepubertal treatment. RESULTS: We found that prepubescent electronic-cigarette vaporized nicotine disrupted puberty and sexual motivation in female but not male rats. In vaped females, vaginal opening was delayed and less time was spent with the male stimulus compared to room-air controls. In contrast, no effect of e-cigarette vapor was observed on pubertal onset or on any measures of sexual behavior in male rats. No effects were observed in either female or male rats on the second partner-preference test. CONCLUSIONS: Prepubescent vaporized nicotine affected the development of reproductive physiology and behavior in female rats but not in male rats, whereas an additional acute exposure to nicotine vapor had no effect in either female or male adult rats. IMPLICATIONS: Given the prevalence of increasingly younger users, more animal research is needed to explore the effects of e-cigarette smoking on multiple developmental systems including reproductive physiology and behavior. This model could be useful in exploring multiple behavioral and physiological endpoints in both sexes. Adjustments to the duration of exposure and control conditions will be necessary for future experiments to best model human use.

Development of a curriculum in cultural determinants of health and health disparities.

INTRODUCTION: Current sociopolitical events coupled with requirement modifications by the Liaison Committee on Medical Education have reinvigorated a need for training in cultural awareness and health disparities in undergraduate medical education. Many institutions, however, have not established longitudinal courses designed to address this content. Additionally, little is known about the change in learners' awareness of cultural determinants of health and health disparities after enrollment in such curricula. In 2016, the authors developed a yearlong required course entitled Cultural Determinants of Health and Health Disparities for first year medical students at a large university medical school in the United States. The course launched in the 2017 academic year. METHODS: Two cohorts participated in twelve 2.5 to 3-hour multi-modal sessions focused on various aspects of healthcare delivery for marginalized populations and factors that contribute to health disparities. The Multicultural Assessment Questionnaire was used pre and post course to assess students' self-evaluated changes in knowledge, skills, and awareness related to cultural competency in healthcare. RESULTS: Students' self-reported knowledge, skills, and awareness scores regarding cultural competence in health care increased from pre to post-course assessment. On the knowledge scale, students' mean score increased from 2.63 to 2.97 (P < .001), with 16% reporting a decreased score, 30% reporting no change, and 54% reporting growth. On the skills scale, students' mean score increased from 2.64 to 3.38 (P < .001), with 11% reporting a decreased score, 17% reporting no change, and 72% reporting growth. On the awareness scale, students' overall score increased from 3.76 to 3.97 (P < .05), with 16% reporting a decreased score, 50% reporting no change, and 34% reporting growth. There were no changes in KSA scores across cohorts pre and post course. CONCLUSION: Perceived knowledge, skills, and awareness related to the importance of cultural competence in healthcare delivery increased at the end of the academic year. This type of longitudinal course model could be broadly adopted at other institutions to enhance patient, peer, and future provider awareness regarding cultural impacts on care and health disparities among vulnerable populations.

Feasibility of a Career Development Intervention for Veterans in Vocational Rehabilitation: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Veterans with psychiatric disorders want additional career development services to support their recovery and pursuit of meaningful employment. However, no career counseling programs have been designed for this specific population. We developed the Purposeful Pathways intervention to fill this need. OBJECTIVE: This study protocol aims to (1) evaluate the feasibility and acceptability of the Purposeful Pathways intervention for veterans living with psychiatric disorders and (2) explore preliminary clinical outcome data. METHODS: A total of 50 veterans who are participating in transitional work vocational rehabilitation services at a Veterans Affairs hospital will be randomized to either treatment as usual or the augmented treatment condition (treatment as usual plus Purposeful Pathways). Feasibility will be assessed via recruitment rates, clinician fidelity to treatment, retention rates, and acceptability of randomization procedures. Acceptability will be assessed via client satisfaction at treatment termination using quantitative and qualitative data collection. Preliminary clinical and vocational outcomes will be assessed at baseline, 6 weeks, 12 weeks (treatment termination), and a 3-month follow-up via quantitative measures assessing vocational functioning, vocational process, and mental and physical functioning. RESULTS: This pilot randomized controlled trial is beginning recruitment in June 2023 and is expected to continue through November 2025. Data collection is expected to be completed by February 2026, with full data analysis completed by March 2026. CONCLUSIONS: Findings from this study will provide information on the feasibility and acceptability of the Purposeful Pathways intervention, as well as secondary outcomes related to vocational functioning, vocational process, and mental and physical functioning. TRIAL REGISTRATION: ClinicalTrials.gov NCT04698967; https://clinicaltrials.gov/ct2/show/NCT04698967. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/47986.

BDNF and stress/mood-related interactions on emotional disorder symptoms, executive functioning, and deliberate self-harm.

Some prior research has suggested that the brain-derived neurotrophic factor (BDNF) gene may amplify responses related to life stress (e.g., depression and anxiety) or associated with negative moods (e.g., self-harm and diminished cognitive functioning). The purpose of this study was to investigate whether stress/mood-related associations with depressive and anxiety symptoms, deliberate self-harm, and executive functioning (EF) are moderated by genotypic variations in BDNF rs10835210 (a relatively understudied BDNF polymorphism) in a nonclinical sample. As part of a larger study, European American social drinkers (N = 132; 43.9% female; M age = 26.0, SD = 7.6) were genotyped for BDNF rs10835210 and were administered self-report measures of subjective life stress, depressive and anxiety symptoms, and history of non-suicidal self-injury (NSSI) and behavioral measures of EF and deliberate self-harm. Results indicated that BDNF significantly moderated the life stress associations with depressive symptoms and NSSI, the anxious mood association with EF, and the depressed mood association with deliberate self-harm behavior. Each of these BDNF × stress/mood interactions were characterized by stress/mood associations that were stronger in individuals with the AA genotype (homozygous for the minor allele) than in individuals possessing a genotype that included the major allele (AC or CC). The main limitations of the present study were use of a cross-sectional design, modest sample size, and investigating only one BDNF polymorphism. Despite these limitations and though preliminary, current findings suggest that variations in BDNF may confer vulnerability to stress or mood, which may result in more adverse emotional, cognitive, or behavioral outcomes.

Chronic pain and problematic substance use for veterans during COVID-19: the moderating role of psychological flexibility.

Background: Chronic pain and problematic substance use are commonly co-occurring and highly detrimental issues that are especially prevalent in U.S. veteran populations. Although COVID-19 made clinical management of these conditions potentially difficult, some research suggests that certain veterans with these conditions did not experience this period as negatively as others. It is thus important to consider whether resilience factors, such as the increasingly-studied process of psychological flexibility, might have led to better outcomes for veterans managing pain and problematic substance use during this time of global crisis. Methods: This planned sub-analysis of a larger cross-sectional, anonymous, and nationally-distributed survey (N = 409) was collected during the first year of the COVID-19 pandemic. Veteran participants completed a short screener and battery of online surveys assessing pain severity and interference, substance use, psychological flexibility, mental health functioning, and pandemic-related quality of life. Results: For veterans with chronic pain and problematic substance use, the pandemic resulted in a significant lowering of their quality of life related to meeting basic needs, emotional health, and physical health compared to veterans with problematic substance use but no chronic pain diagnosis. However, moderation analyses revealed that veterans with these comorbid conditions experienced less negative impacts from the pandemic on quality of life and mental health when they reported greater psychological flexibility. For veterans with problematic substance use only, psychological flexibility was also related to better mental health functioning, but did not significantly correlate with their quality of life. Conclusion: Results highlight how COVID-19 differentially impacted veterans with both problematic substance use and chronic pain, such that this group reported particularly negative impacts of the pandemic on multiple areas of quality of life. However, our findings further emphasize that psychological flexibility, a modifiable resiliency process, also buffered against some of the negative impacts of the pandemic on mental health and quality of life. Given this, future research into the impact of natural crises and healthcare management should investigate how psychological flexibility can be targeted to help increase resiliency for veterans with chronic pain and problematic substance use.

An Avatar-Led Web-Based and SMS Text Message Smoking Cessation Program for Socioeconomically Disadvantaged Veterans: Pilot Randomized Controlled Trial.

BACKGROUND: Despite the declining prevalence of cigarette smoking in the United States, socioeconomically disadvantaged veterans receiving care from the Veterans Health Administration have a high prevalence of smoking. Currently, available treatment options for these veterans focus on tobacco users who are ready to quit and have limited reach. Consequently, there is a great need for accessible, effective smoking cessation interventions for veterans at all levels of readiness to quit smoking. OBJECTIVE: To address these needs, we developed Vet Flexiquit, a web-based Acceptance and Commitment Therapy program for veterans, and evaluated its acceptability (primary aim), efficacy, and impact on theory-based change processes relative to the National Cancer Institute's SmokefreeVET program in a pilot randomized controlled trial. METHODS: Participants (N=49) were randomized 1:1 to receive either the Vet Flexiquit (n=25) or SmokefreeVET (n=24) web program. Both groups received SMS text messages as part of the intervention for 6 weeks. Both interventions are fully automated and self-guided. Primary outcome data were collected at 3 months after the randomization. Self-reported smoking abstinence was biochemically verified using saliva cotinine. Multivariable logistic regression, negative binomial regression, and linear regression models were used to evaluate the association between the treatment arm and outcomes of interest. RESULTS: Acceptability, as measured by overall treatment satisfaction, was high and similar across treatment arms: 100% (17/17) for Vet Flexiquit and 95% (18/19) for SmokefreeVET. Acceptability, as measured by utilization, was more modest (log-ins: M=3.7 for Vet Flexiquit and M=3.2 for SmokefreeVET). There were no statistically significant differences between treatment arms for any acceptability measures. Similarly, there were no statistically significant differences between treatment arms in the secondary outcomes of smoking cessation or change in Acceptance and Commitment Therapy's theory-based processes. In open-ended survey responses, some veterans in both treatment arms expressed interest in having support from a professional or peer to enhance their experience, as well as an expanded SMS text messaging program. CONCLUSIONS: Both programs had high ratings of acceptability, limited utilization, and a similar impact on cessation and cessation processes. Taken together with the qualitative data suggesting that additional support may enhance participants' experience of both programs, these preliminary findings suggest that the programs may have similar outcomes among veterans who are looking for a digital cessation treatment option and that integrating provider or peer support and enhancing the SMS text messaging program holds promise as a means of boosting engagement and outcomes for both programs. TRIAL REGISTRATION: ClinicalTrials.gov NCT04502524; https://clinicaltrials.gov/ct2/show/NCT04502524.

An Online Acceptance and Mindfulness Intervention for Chronic Pain in Veterans: Development and Protocol for a Pilot Feasibility Randomized Controlled Trial.

BACKGROUND: In the veteran community, chronic pain is particularly prevalent and often debilitating. Until recently, veterans with chronic pain were offered primarily pharmacological intervention options, which rarely suffice and can also have negative health consequences. To better address chronic pain in veterans, the Veterans Health Administration has invested in novel, nonpharmacological behavior interventions that target both pain management and chronic pain-related functional issues. One approach, acceptance and commitment therapy (ACT) for chronic pain, is supported by decades of efficacy evidence for improving pain outcomes; however, ACT can be difficult to obtain owing to issues such as a lack of trained therapists or veterans having difficulty committing to the time and resources needed for the full clinician-led ACT protocol. Given the strong ACT evidence base combined with access limitations, we set out to develop and evaluate Veteran ACT for Chronic Pain (VACT-CP), an online program guided by an embodied conversational agent to improve pain management and functioning. OBJECTIVE: The aims of this study are to develop, iteratively refine, and then conduct a pilot feasibility randomized controlled trial (RCT) of a VACT-CP group (n=20) versus a waitlist and treatment-as-usual control group (n=20). METHODS: This research project includes 3 phases. In phase 1, our research team consulted with pain and virtual care experts, developed the preliminary VACT-CP online program, and conducted interviews with providers to obtain their feedback on the intervention. In phase 2, we incorporated feedback from phase 1 into the VACT-CP program and completed initial usability testing with veterans with chronic pain. In phase 3, we are conducting a small pilot feasibility RCT, with the primary outcome being assessment of usability of the VACT-CP system. RESULTS: This study is currently in phase 3; recruitment for the RCT began in April 2022 and is expected to continue through April 2023. Data collection is expected to be completed by October 2023, with full data analysis completed by late 2023. CONCLUSIONS: The findings from this research project will provide information on the usability of the VACT-CP intervention, as well as secondary outcomes related to treatment satisfaction, pain outcomes (pain-related daily functioning and pain severity), ACT processes (pain acceptance, behavioral avoidance, and valued living), and mental and physical functioning. TRIAL REGISTRATION: ClinicalTrials.gov NCT03655132; https://clinicaltrials.gov/ct2/show/NCT03655132. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45887.

Chronic periadolescent leuprolide exposure affects the development of reproductive physiology and behavior of female and male rats differently, but both mature after treatment termination.

BACKGROUND: GnRH agonists have been used to halt the development of puberty in children with precocious puberty since the 1980s. Recently, drugs like Lupron Depot® (leuprolide acetate), have been used to suppress pubertal progression in adolescents who are questioning their gender identity. However, few preclinical studies have been conducted to investigate potential effects of using GnRH agonists in this context. METHODS: The present study tested the effects of daily leuprolide treatment (50 µg/kg, postnatal day (PD) 25-50) on pubertal onset in female (i.e., vaginal opening) and male (i.e., preputial separation) Long-Evans rats. The first estrous cycle immediately after vaginal opening was also measured. Sexual behavior and sexual motivation were tested using the partner-preference paradigm. Female rats were tested during the first behavioral estrus after treatment ended (between PD 51-64). Male rats were tested weekly for four consecutive weeks starting three days after treatment ended (PD 53). RESULTS: Consistent with previous findings, leuprolide significantly delayed pubertal onset in both female and male rats. In addition, the first estrous cycle during the treatment period was disrupted by leuprolide, as indicated by a failure to cycle into estrus after vaginal opening until treatment ended. However, leuprolide affected neither sexual motivation nor fertility when female rats were tested within 14 days of leuprolide treatment ending. In contrast, the development of copulatory behavior and sexual motivation was significantly delayed by leuprolide in male rats; however, mature reproductive behavior was observed by the fourth week post-treatment. CONCLUSIONS: Taken together with previous findings, the present results indicate that male rats may be more sensitive to periadolescent leuprolide administration, taking longer to overcome the effects of leuprolide than female rats. Nevertheless, not long after leuprolide treatment is discontinued, sex-typical reproductive physiology and behavior emerge fully in female and male rats, indicating that the drug's effects are not permanent. If translatable to humans, leuprolide may be a reversible option to give adolescents more time to consider their gender identity with minimal long-term effects on sexual development.

Intersectionality in Intervention Development: Insights From Formative Work on a Tailored Tobacco Cessation Program for LGBTQIA+ Young Adults.

Tailored tobacco cessation interventions focusing on minoritized communities are proliferating, but the extent to which these interventions address the needs of individuals with multiple minoritized social identities is unclear. We developed Empowered, Queer, Quitting, and Living (EQQUAL), an avatar-led digital smoking cessation intervention tailored for lesbian, gay, bisexual, transgender, queer or questioning, intersex, asexual, and more (LGBTQIA+) young adults based on acceptance and commitment therapy (ACT), via a multistage user-centered design process. The purpose was to evaluate feedback from EQQUAL development activities using an intersectional lens. Intersectionality is a paradigm created by Kimberlé Crenshaw illustrating the multiple social identities each person possesses along with the marginalization of these different social identities. We conducted a rapid deductive content analysis focused on intersectional design gaps using interviewer notes from user testing (n = 7), a diary study (n = 8), and treatment satisfaction responses from a single-arm trial of the EQQUAL intervention (n = 22). Feedback related to intersectional design fell under three broad themes: (a) inadequate representativeness of the avatar, (2) inadequate representativeness within the program broadly, and (3) non-inclusive ACT intervention content. Feedback on inclusiveness included reference to socioeconomic status, race/ethnicity, religious/cultural affiliation, and ability/disability. Although we previously found that EQQUAL was highly acceptable and showed promise in terms of efficacy in a single-arm pilot trial, we identified several gaps in intersectional design as the iterative intervention development proceeded. Because intersectional design is a critical part of developing interventions with a health equity focus, applying standardized procedures for intersectional design and analysis could improve intervention design and better address tobacco cessation treatment needs of individuals who may experience multiple forms of marginalization.