Provider-patient relationships and trauma among pregnant patients with opioid-use disorder.

BACKGROUND AND OBJECTIVES: The provider-patient relationship is integral to medical practice and health outcomes, particularly among vulnerable patient populations. This study compared the provider-patient relationship among pregnant patients with opioid-use disorder (OUD), who did or did not have a history of moderate to severe trauma. METHODS: This was an exploratory data analysis of 119 patients enrolled in the Support Models for Addiction Related Treatment trial. Probable posttraumatic stress disorder (PTSD) was determined by a score ≥ 31 on the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. The provider-patient relationship was assessed at 26 ± 4 weeks of pregnancy using the Kim Alliance Scale (KAS). Multivariable regression was used to examine the association of KAS with probable PTSD among pregnant people with OUD. RESULTS: The mean KAS score for pregnant participants without probable PTSD (N = 88) was 61.4 (SD ± 2.8) and for pregnant participants with probable PTSD (N = 31) was 59.6 (SD ± 3.7). Results demonstrated significant differences in KAS scores between those with and without probable PTSD after adjusting for demographic variables. Adjusted mean total KAS scores and scores on Empowerment and Communication subscales were significantly lower among those with probable PTSD compared to those without (p = .04 and 0.02, respectively) but did not differ significantly on Collaboration and Integration subscales. CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: Analyses show an association between probable PTSD and provider-patient relationship among pregnant patients with OUD, with those with probable PTSD having a worse alliance with obstetric providers. This novel finding helps characterize the provider-patient relationship among a uniquely vulnerable population and can inform efforts to integrate trauma-informed practices into prenatal care.

Does Symptom-Onset Treatment With Sertraline Improve Functional Impairment for Individuals With Premenstrual Dysphoric Disorder?: A Randomized Controlled Trial.

PURPOSE/BACKGROUND: Daily treatment with sertraline improves functional impairment among individuals with premenstrual dysphoric disorder (PMDD). We do not know whether treatment initiated at symptom onset also improves functional impairment. METHODS/PROCEDURES: This 3-site, double blind, randomized, clinical trial compared sertraline (25-100 mg) to similar appearing placebo, both administered at symptom onset, for reduction of PMDD symptoms. Ninety participants were allocated to sertraline and 94 participants to placebo. Functional outcomes from the Daily Ratings of the Severity of Problems included (1) reduced productivity or efficiency at work, school, home, or daily routine; (2) interference with hobbies or social activities; and (3) interference with relationships. Items were measured from 1 (no interference) to 6 (extreme interference) and averaged for the final 5 luteal phase days. This secondary analysis examined whether improvement in functional domains was greater for those allocated to sertraline compared with placebo. Second, we used causal mediation analyses to explore whether specific PMDD symptoms mediated functional improvement. RESULTS/FINDINGS: Only relationship functioning improved significantly with active treatment between baseline and the end of the second cycle (active group mean [SD] change, -1.39 [1.38]; placebo group mean change, -0.76 [1.20]; ß = -0.40; SE, 0.15; P = 0.009). The total effect of treatment on interference was -0.37 (95% confidence interval [CI], -0.66 to -0.09; P = 0.011). Given the nonsignificant direct effect (0.11; 95% CI, -0.07 to 0.29; P = 0.24) and significant indirect effect (-0.48; 95% CI, -0.71 to -0.24; P < 0.001), amelioration of anger/irritability likely mediated reductions in relationship interference. IMPLICATIONS/CONCLUSIONS: That anger/irritability mediates impairments in relationship functioning has face validity but should be replicated in other data sets. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00536198 .

Substance Use Disorder Detection Rates Among Providers of General Medical Inpatients.

BACKGROUND: The prevalence of substance use disorders is higher among medical inpatients than in the general population, placing inpatient providers in a prime position to detect these patients and intervene. OBJECTIVE: To assess provider detection rates of substance use disorders among medical inpatients and to identify patient characteristics associated with detection. DESIGN: Data drawn from a cluster randomized controlled trial that tested the effectiveness of three distinct implementation strategies for providers to screen patients for substance use disorders and deliver a brief intervention (Clinical Trials.gov : NCT01825057). PARTICIPANTS: A total of 1076 patients receiving care from 13 general medical inpatient units in a large teaching hospital participated in this study. MAIN MEASURES: Data sources included patient self-reported questionnaires, a diagnostic interview for substance use disorders, and patient medical records. Provider detection was determined by diagnoses documented in medical records. KEY RESULTS: Provider detection rates were highest for nicotine use disorder (72.2%) and lowest for cannabis use disorder (26.4%). Detection of alcohol use disorder was more likely among male compared to female patients (OR (95% CI) = 4.0 (1.9, 4.8)). When compared to White patients, alcohol (OR (95% CI) = 0.4 (0.2, 0.6)) and opioid (OR (95% CI) = 0.2 (0.1, 0.7)) use disorders were less likely to be detected among Black patients, while alcohol (OR (95% CI) = 0.3 (0.0, 2.0)) and cocaine (OR (95% CI) = 0.3 (0.1, 0.9)) use disorders were less likely to be detected among Hispanic patients. Providers were more likely to detect nicotine, alcohol, opioid, and other drug use disorders among patients with higher addiction severity (OR (95% CI) = 1.20 (1.08-1.34), 1.62 (1.48, 1.78), 1.46 (1.07, 1.98), 1.38 (1.00, 1.90), respectively). CONCLUSIONS: Findings indicate patient characteristics, including gender, race, and addiction severity impact rates of provider detection. Instituting formal screening for all substances may increase provider detection and inform treatment decisions.

Implementing Motivational Interviewing for Substance Misuse on Medical Inpatient Units: a Randomized Controlled Trial.

BACKGROUND: General medical hospitals provide care for a disproportionate share of patients who misuse substances. Hospitalization provides a unique opportunity to identify and motivate patients to address their substance misuse. OBJECTIVE: To determine the effectiveness of three strategies for implementing motivational interviewing for substance misuse with general medical inpatients. DESIGN: Type 3 hybrid effectiveness-implementation randomized controlled trial (Clinical Trials.gov: NCT01825057). PARTICIPANTS: Thirty-eight providers (physicians, physician assistants, nurses) from 13 general medical inpatient services, and 1173 of their patients admitted to an academically affiliated acute care hospital. INTERVENTIONS: Implementation strategies included (1) a continuing medical education workshop on detection of substance misuse and provision of a motivational interview; (2) workshop plus bedside supervision (apprenticeship condition); and (3) a workshop plus ability to place a medical order for an interview from a consultation-liaison service (consult condition). MAIN MEASURES: Primary outcomes were the percentage of study-eligible patients who received an interview for substance misuse and the integrity (adherence, competence) of the interviews. The secondary outcome was the percent of patient statements within the interviews that indicated motivation for reducing substance misuse. KEY RESULTS: 20.5% of patients in the consult condition received an interview, compared to 0.8% (Hedge's g = 1.49) and 3.0% (Hedge's g = 1.26) in the respective workshop only and apprenticeship conditions (p < 0.001). Motivational interviews in the consult condition were performed with more fundamental motivational interviewing adherence and competence than the other conditions. Most statements made by patients during the interviews favored reducing substance misuse, with no differences between conditions. CONCLUSIONS: Providers' ability to place an order to have experts from the consultation-liaison service deliver a motivational interview was a more effective implementation strategy than a workshop or apprenticeship method for ensuring motivational interviewing is available to medical inpatients who misuse substances. TRIAL REGISTRY: NCT01825057.

A randomized controlled trial of screening and brief interventions for substance misuse in reproductive health.

BACKGROUND: Screening, brief intervention, and referral to treatment may reduce substance misuse but has received minimal study among women who are treated in reproductive health settings. OBJECTIVE: The purpose of this study was to determine whether "screening, brief intervention and referral to treatment" that is delivered either electronically or by clinician are more effective than enhanced usual care in decreasing days of primary substance use. STUDY DESIGN: Women from 2 reproductive centers who smoked cigarettes or misused alcohol, illicit drugs, or prescription medication were allocated randomly to "screening, brief intervention and referral to treatment" delivered electronically or by clinician or to enhanced usual care. Assessments were completed at baseline and at 1-, 3-, and 6-months after a baseline has been established. Coprimary outcomes were days/months of primary substance use and postintervention treatment use. A sample size of 660 women was planned; randomization was stratified by primary substance use and pregnancy status. "Screening, brief intervention and referral to treatment" groups were compared with enhanced usual care groups with the use of generalized estimation equations, and effect sizes were calculated with the use of Cohen's d. RESULTS: Between September 2011 and January 2015, women were assigned randomly to a group: 143 women (16.8% pregnant) in the electronic-delivered "screening, brief intervention and referral to treatment" group, 145 women (18.6% pregnant) in the clinician-delivered "screening, brief intervention and referral to treatment" group, and 151 women (19.2% pregnant) in the enhanced usual care group; the retention was >84%. Based on the generalized estimating equations model, predicted mean days per month of use at baseline for primary substance were 23.9 days (95% confidence interval, 22.4-25.5) for the electronic-delivered group, 22.8 days (95% confidence interval, 21.4-24.3) for the clinician-delivered group, and 23.5 days (95% confidence interval, 22.2, 24.9) for enhanced usual care, which respectively declined to 20.5 days (95% confidence interval, 19.0-22.2), 19.8 days (95% confidence interval,18.5-21.3), and 21.9 days (95% confidence interval, 20.7-23.1) at 1 month; 16.9 days (95% confidence interval, 15.0-19.0), 16.6 days (95% confidence interval, 14.8-18.6), and 19.5 days (95% confidence interval, 18.1-21.1) at 3 months; and 16.3 days (95% confidence interval, 14.3-18.7), 16.3 days (95% confidence interval, 14.4-18.5), and 17.9 days (95% confidence interval, 16.1-19.9) at 6 months. Estimated declines were greater in the electronic-delivered group (ß [standard error]=-0.090[0.034]; P=.008; Cohen's d, 0.19 at 1 month, 0.30 at 3 months, and 0.17 at 6 months) and the clinician-delivered group (ß [standard error]=-0.078[0.037]; P=.038; Cohen's d, 0.17 at 1 month, 0.22 at 3 months, and 0.06 at 6 months) compared with enhanced usual care. Treatment use did not differ between groups. CONCLUSION: "Screening, brief intervention and referral to treatment" significantly decreased days of primary substance use among women in reproductive healthcare centers; neither resulted in more treatment use than enhanced usual care.

Postpartum Contraceptive use and Rapid Repeat Pregnancy Among Women who use Substances.

BACKGROUND: Postpartum contraception is especially important for women who use alcohol and other substances, given the risk of possible rapid repeat pregnancy and prenatal substance exposure. However, little is known about postpartum contraceptive use among women with substance use histories. OBJECTIVE: To characterize postpartum contraceptive initiation, 24-month continuation, and rapid repeat pregnancy among women who used substances during pregnancy. METHODS: This is a secondary analysis of 161 pregnant women who enrolled in a randomized clinical trial to treat substance use in pregnancy and completed at least one follow-up assessment. Women were eligible if they were less than 28 weeks gestation and reported alcohol or illicit drug use within the past 30 days. Participants were recruited from two hospital-based OB/GYN clinics between 2006 and 2010, and completed assessments at delivery and 3-, 12-, and 24-months postpartum. RESULTS: Past 30-day use of any substance (not including tobacco) was 52.4%, 58.3%, and 59.8% at 3-, 12-, and 24-month follow-up, respectively. Marijuana was the most commonly reported illicit substance (as high as 48.1%). Rates of any contraceptive use were 71.3%, 66.7% and 65.3% at 3-, 12-, and 24-month follow-up, respectively; DepoProvera and condoms were the most common methods. Rapid repeat pregnancy occurred in 28% of participants by 24-month follow-up. Conclusions/Importance: Postpartum contraceptive use among substance using women was at or near 70%, which is comparable to other samples of postpartum women. Innovative efforts are needed to promote effective contraceptive use among postpartum women in general and among those who use substances in particular.

CDC Grand Rounds: Public Health Strategies to Prevent Neonatal Abstinence Syndrome.

Neonatal abstinence syndrome (NAS) is a drug withdrawal syndrome that most commonly occurs in infants after in utero exposure to opioids, although other substances have also been associated with the syndrome (1). NAS usually appears within 48-72 hours of birth with a constellation of clinical signs, including central nervous system irritability (e.g., tremors), gastrointestinal dysfunction (e.g., feeding difficulties), and temperature instability (1) (Box 1). Opioid exposure during pregnancy might result from clinician-approved use of prescription opioids for pain relief; misuse or abuse of prescription opioids; illicit use (e.g., heroin); or medication-assisted treatment (MAT) of opioid use disorder (2) (Box 2).

Economic evaluation of a behavioral intervention versus brief advice for substance use treatment in pregnant women: results from a randomized controlled trial.

BACKGROUND: Substance use in pregnancy is associated with severe maternal and fetal morbidities and substantial economic costs. However, few studies have evaluated the cost-effectiveness of substance use treatment programs in pregnant women. The purpose of this study was to evaluate the economic impact of a behavioral intervention that integrated motivational enhancement therapy with cognitive behavioral therapy (MET-CBT) for treatment of substance use in pregnancy, in comparison with brief advice. METHODS: We conducted an economic evaluation alongside a clinical trial by collecting data on resource utilization and performing a cost minimization analysis as MET-CBT and brief advice had similar effects on clinical outcomes (e.g., alcohol and drug use and birth outcomes). Costs were estimated from the health care system's perspective and included intervention costs, hospital facility costs, physician fees, and costs of psychotropic medications from the date of intake assessment until 3-month postpartum. We compared effects of MET-CBT on costs with those of brief advice using Wilcoxon rank sum tests. RESULTS: Although the integrated MET-CBT therapy had higher intervention cost than brief advice (median = $1297/participant versus $303/participant, p < 0.01), costs of care during the prenatal period, delivery, and postpartum period, as well as for psychotropic medications, were comparable between the two groups (all p values ≥ 0.55). There was no statistically significant difference in overall cost of care (median total cost = $26,993/participant for MET-CBT versus $27,831/participant for brief advice, p = 0.90). CONCLUSIONS: The MET-CBT therapy and brief advice resulted in similar clinical outcomes and overall medical costs. Further research incorporating non-medical costs, targeting women with more severe substance use disorders, and evaluating the impact of MET-CBT on participants' quality of life will provide additional insights. TRIAL REGISTRATION: ClinicalTrials.gov NCT00227903 . Registered 27 September 2005.

Early Childhood Adversity and Pregnancy Outcomes.

OBJECTIVES: To examine the association between adverse childhood experiences (ACEs) and pregnancy outcomes; to explore mediators of this association including psychiatric illness and health habits. METHODS: Exposure to ACEs was determined by the Early Trauma Inventory Self Report Short Form; psychiatric diagnoses were generated by the Composite International Diagnostic Interview administered in a cohort of 2303 pregnant women. Linear regression and structural equation modeling bootstrapping approaches tested for multiple mediators. RESULTS: Each additional ACE decreased birth weight by 16.33 g and decreased gestational age by 0.063. Smoking was the strongest mediator of the effect on gestational age. CONCLUSIONS: ACEs have an enduring effect on maternal reproductive health, as manifested by mothers' delivery of offspring that were of reduced birth weight and shorter gestational age.

Clinical correlates of prescription opioid analgesic use in pregnancy.

A 2012 committee opinion from the American College of Obstetricians and Gynecologists highlights the considerable increase in opioid addiction in recent years, yet little is known about clinical correlates of prescribed opioids among pregnant women. This study examines clinical and demographic factors associated with the use of opioid analgesics in pregnancy. Data were derived from a prospective cohort study of pregnant women. Participants were administered the Composite International Diagnostic Interview to identify depressive and anxiety disorders and data on medication use were gathered at three assessment points and classified according to the Anatomical Therapeutic Chemical Code (ATC) classification system ATC group N02A. Participants included 2,748 English or Spanish speaking pregnant women. Six percent (n = 165) of women used opioid analgesics at any point in pregnancy. More pregnant women using opioids met diagnostic criteria for major depressive disorder (16 vs. 8 % for non users), generalized anxiety disorder (18 vs. 9 % for non users), post-traumatic stress disorder (11 vs. 4 % for non users) and panic disorder (6 vs. 4 % for non users). Women who reported opioid use were also significantly more likely than non users to report using illicit drugs and almost three times as likely to report smoking cigarettes in the second or third trimester of pregnancy (4 and 23 %, respectively) as compared to non-opioid users (0.5 and 8 %). The use of opioids in pregnancy was associated with higher levels of psychiatric comorbidity and use of other substances as compared to non-opioid users.

Antidepressant use in pregnant and postpartum women.

Women in their reproductive years are at risk of experiencing depressive and anxiety disorders. As such, it is likely that pregnant women will undergo treatment with antidepressants. We review the risk of adverse birth outcomes and neonatal complications subsequent to antidepressant use in pregnancy. An inconsistent literature shows that antidepressant exposure is associated with shortened gestations and diminished fetal growth; these effects are small. Transitory neonatal signs are seen in some neonates after exposure to antidepressants in utero. No specific pattern of malformations has been consistently associated with antidepressants, with the possible exception of paroxetine and cardiac malformations. There is inconclusive evidence of a link between antidepressants in late pregnancy and persistent pulmonary hypertension in the newborn. Extensive study finds that antidepressants cannot be considered major teratogens. It is likely that confounding factors contribute to a number of the adverse effects found to be associated with antidepressant use in pregnancy.

Formative evaluation of an emergency department clinical decision support system for agitation symptoms: a study protocol.

INTRODUCTION: The burden of mental health-related visits to emergency departments (EDs) is growing, and agitation episodes are prevalent with such visits. Best practice guidance from experts recommends early assessment of at-risk populations and pre-emptive intervention using de-escalation techniques to prevent agitation. Time pressure, fluctuating work demands, and other systems-related factors pose challenges to efficient decision-making and adoption of best practice recommendations during an unfolding behavioural crisis. As such, we propose to design, develop and evaluate a computerised clinical decision support (CDS) system, Early Detection and Treatment to Reduce Events with Agitation Tool (ED-TREAT). We aim to identify patients at risk of agitation and guide ED clinicians through appropriate risk assessment and timely interventions to prevent agitation with a goal of minimising restraint use and improving patient experience and outcomes. METHODS AND ANALYSIS: This study describes the formative evaluation of the health record embedded CDS tool. Under aim 1, the study will collect qualitative data to design and develop ED-TREAT using a contextual design approach and an iterative user-centred design process. Participants will include potential CDS users, that is, ED physicians, nurses, technicians, as well as patients with lived experience of restraint use for behavioural crisis management during an ED visit. We will use purposive sampling to ensure the full spectrum of perspectives until we reach thematic saturation. Next, under aim 2, the study will conduct a pilot, randomised controlled trial of ED-TREAT at two adult ED sites in a regional health system in the Northeast USA to evaluate the feasibility, fidelity and bedside acceptability of ED-TREAT. We aim to recruit a total of at least 26 eligible subjects under the pilot trial. ETHICS AND DISSEMINATION: Ethical approval by the Yale University Human Investigation Committee was obtained in 2021 (HIC# 2000030893 and 2000030906). All participants will provide informed verbal consent prior to being enrolled in the study. Results will be disseminated through publications in open-access, peer-reviewed journals, via scientific presentations or through direct email notifications. TRIAL REGISTRATION NUMBER: NCT04959279; Pre-results.

Reporting Perinatal Substance Use to Child Protective Services: Obstetric Provider Perspectives on the Impact on Care.

Objective: To understand obstetric provider perspectives on child protective services (CPS)-mandated reporting requirements and how they affect care for pregnant and postpartum patients with opioid use disorder (OUD). Methods: Key informant interviews were conducted virtually with obstetricians, nurse practitioners, and social workers caring for obstetric patients (n = 12). Providers were asked about their experience as mandated reporters working with patients with OUD. Transcripts were independently coded by two staff, and content analysis was used to identify themes. Results: Our analysis resulted in six thematic areas, including CPS-mandated strengths, concerns related to CPS reporting requirements, implementation of mandates, supporting patients after CPS report, communication between stakeholders, and the impact on care. Providers noted that the fear of CPS involvement causes some patients to delay or not engage in care. Other patients are hesitant to accept medications for OUD for fear of CPS involvement. The inconsistencies in how reporting mandates are applied and how CPS handles cases make communication about the policies challenging for providers and create anxiety for patients. Conclusions: The results of this study indicate that mandated reporting requirements and the potential for CPS involvement are perceived to have minimal positive effects on perinatal individuals with OUD and may negatively affect patients and their care. Clinicaltrials.gov number: NCT04240392.

The serotonin reuptake inhibitor fluoxetine induces human fetal membrane sterile inflammation through p38 MAPK activation.

Serotonin Reuptake Inhibitors (SRIs) are often used as first line therapy for depression and other psychiatric disorders. SRI use during pregnancy is associated with preterm premature rupture of membranes (PPROM) and subsequent preterm birth. The objective of this study was to investigate the mechanism(s) responsible for SRI-associated PPROM. Putative mechanisms underlying PPROM include fetal membrane (FM) inflammation, increased apoptosis, and/or accelerated senescence, the later which may be reversed by statins. Human FM explants from normal term deliveries without labor, infection, or antidepressant use were treated with or without the SRI, fluoxetine (FLX), either alone or in the presence of a p38 MAPK inhibitor or the statins, simvastatin or rosuvastatin. FMs were also collected from women either unexposed or exposed to FLX during pregnancy. FLX significantly increased FM p38 MAPK activity and secretion of inflammatory IL-6. Inhibition of p38 MAPK reduced FM IL-6 secretion in response to FLX. Statins did not reduce the SRI-induced FM IL-6 production. FMs from women exposed to FLX during pregnancy expressed elevated levels of p38 MAPK activity compared to matched unexposed women. FMs exposed to FLX did not exhibit signs of increased apoptosis and/or accelerated senescence. These results indicate that the SRI, FLX, may induce sterile FM inflammation during pregnancy through activation of the p38 MAPK pathway, and in the absence of apoptosis and senescence. These findings may better inform clinicians and patients as they weigh the risks and benefits of SRI antidepressant treatment during pregnancy.

Depression and serotonin reuptake inhibitor treatment as risk factors for preterm birth.

BACKGROUND: Major depressive disorder and the use of serotonin reuptake inhibitors (SRIs) in pregnancy have been associated with preterm birth. Studies that have attempted to separate effects of illness from treatment have been inconclusive. We sought to explore the separate effects of SRI use and major depressive episodes in pregnancy on risk of preterm birth. METHODS: We conducted a prospective cohort study of 2793 pregnant women, oversampled for a recent episode of major depression or use of an SRI. We extracted data on birth outcomes from hospital charts and used binary logistic regression to model preterm birth (<37 weeks' gestation). We used ordered logistic regression to model early (<34 weeks' gestation) or late (34-36 weeks) preterm birth, and we used nominal logistic regression to model preterm birth antecedents (spontaneous preterm labor/preterm premature rupture of membranes/preterm for medical indications/term). RESULTS: Use of an SRI, both with (odds ratio = 2.1 [95% confidence interval = 1.0-4.6]) and without (1.6 [1.0-2.5]) a major depressive episode, was associated with preterm birth. A major depressive episode without SRI use (1.2 [0.68-2.1]) had no clear effect on preterm birth risk. None of these exposures was associated with early preterm birth. Use of SRIs in pregnancy was associated with increases in spontaneous but not medically indicated preterm birth. CONCLUSIONS: SRI use increased risk of preterm birth. Although the effect of a major depressive episode alone was unclear, symptomatic women undergoing antidepressant treatment had elevated risk.

Psychiatric Symptoms Across the Menstrual Cycle in Adult Women: A Comprehensive Review.

LEARNING OBJECTIVE: After participating in this activity, learners should be better able to:• Discuss and outline the general and overlapping effects of the menstrual cycle on women's mental health. ABSTRACT: A growing body of research demonstrates menstrual cycle-dependent fluctuations in psychiatric symptoms; these fluctuations can therefore be considered as prevalent phenomena. Possible mechanisms underlying these fluctuations posit behavioral, psychological, and neuroendocrine influences. Recent reviews document cyclic exacerbation of symptoms and explore these mechanisms in the context of specific and often single disorders. The question remains, however, as to whether there are general and overlapping effects of the menstrual cycle on women's mental health. To address this gap, we synthesized the literature examining the exacerbation of a variety of psychiatric symptoms across the menstrual cycle in adult women. Results show that the premenstrual and menstrual phases are most consistently implicated in transdiagnostic symptom exacerbation. Specifically, strong evidence indicates increases in psychosis, mania, depression, suicide/suicide attempts, and alcohol use during these phases. Anxiety, stress, and binge eating appear to be elevated more generally throughout the luteal phase. The subjective effects of smoking and cocaine use are reduced during the luteal phase, but fewer data are available for other substances. Less consistent patterns are demonstrated for panic disorder, symptoms of posttraumatic stress disorder, and borderline personality disorder, and it is difficult to draw conclusions for symptoms of generalized anxiety disorder, social anxiety disorder, obsessive-compulsive disorder, and trichotillomania because of the limited data. Future research should focus on developing standardized approaches to identifying menstrual cycle phases and adapting pharmacological and behavioral interventions for managing fluctuations in psychiatric symptoms across the menstrual cycle.

Online randomised factorial trial of electronic Screening and Brief Intervention for alcohol use in pregnancy: a study protocol.

INTRODUCTION: Approximately 1 in 7 pregnant women in the USA report past-month alcohol use. Strong evidence connects prenatal alcohol exposure with a range of adverse perinatal outcomes, including the spectrum of conditions known as fetal alcohol spectrum disorders. Screening and Brief Intervention (SBI) has been recommended for pregnant women but has proven difficult to implement. This study will test the efficacy of single-session technology-delivered SBI (electronic SBI) for alcohol use in pregnancy, while simultaneously evaluating the possible additional benefit of tailored text messages and/or booster sessions in a 3×2 factorial trial. METHOD AND ANALYSIS: This full factorial trial will use online advertising and clinic-based flyers to recruit pregnant women meeting criteria for unhealthy alcohol use, and randomly assign them to one of six conditions crossing three levels of brief intervention (none, single 120-minute session and single session plus two 5-minute boosters) with two levels of tailored text messaging (none vs twice weekly messages). The primary analysis will test for dose-response effects of the brief intervention on alcohol abstinence, defined as no self-report of alcohol use in the 90 days prior to 34 weeks' gestation, and negative results for ethyl glucuronide analysis of fingernail samples. Secondary analyses will examine main and interaction effects of tailored text messaging as well as intervention effects on birth outcomes. ETHICS AND DISSEMINATION: Ethical approval was provided by the Michigan State University Biomedical and Health Institutional Review Board (STUDY00005298). Results will be presented at conferences and community forums, in addition to being published in a peer-reviewed journal. Intervention content demonstrating sufficient efficacy and safety will be made publicly available. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04332172).

Qualitative study of patient experiences and care observations during agitation events in the emergency department: implications for systems-based practice.

OBJECTIVES: Agitation, defined as excessive psychomotor activity leading to aggressive or violent behaviour, is prevalent in the emergency department (ED) due to rising behavioural-related visits. Experts recommend use of verbal de-escalation and avoidance of physical restraint to manage agitation. However, bedside applications of these recommendations may be limited by system challenges in emergency care. This qualitative study aims to use a systems-based approach, which considers the larger context and system of healthcare delivery, to identify sociotechnical, structural, and process-related factors leading to agitation events and physical restraint use in the ED. DESIGN: Qualitative study using a grounded theory approach to triangulate interviews of patients who have been physically restrained with direct observations of agitation events. SETTING: Two EDs in the Northeast USA, one at a tertiary care academic centre and the other at a community-based teaching hospital. PARTICIPANTS: We recruited 25 individuals who experienced physical restraint during an ED visit. In addition, we performed 95 observations of clinical encounters of agitation events on unique patients. Patients represented both behavioural (psychiatric, alcohol/drug use) and non-behavioural (medical, trauma) chief complaints. RESULTS: Three primary themes with implications for systems-based practice of agitation events in the ED emerged: (1) pathways within health and social systems; (2) interpersonal contexts as reflections of systemic stressors on behavioural emergency care and (3) systems-based and patient-oriented strategies and solutions. CONCLUSIONS: Agitation events represented manifestations of patients' structural barriers to care from socioeconomic inequities and high burden of emotional and physical trauma as well as staff members' simultaneous exposure to external stressors from social and healthcare systems. Potential long-term solutions may include care approaches that recognise agitated patients' exposure to psychological trauma, improved coordination within the mental health emergency care network, and optimisation of physical environment conditions and organisational culture.