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\u27 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)

Impact of the COVID-19 pandemic on participants in pragmatic clinical trials for chronic pain: implications for trial outcomes and beyond

ObjectiveThe COVID-19 pandemic had profound effects on society, including those living with chronic pain. This study sought to examine pandemic impacts on individuals enrolled in pragmatic clinical trials focused on nonpharmacological treatments for chronic pain.MethodsWe evaluated responses to a questionnaire on COVID-19 impacts that had been administered to participants (n=2024) during study enrollment in 3 pragmatic clinical trials for chronic pain treatment. All trials were part of the National Institutes of Health (NIH)-Department of Veterans Affairs (VA)-Department of Defense (DOD) Pain Management Collaboratory. COVID-19-related impacts on access to health care, mental health, finances, ability to meet basic needs, and social support were assessed.ResultsPandemic impacts were found in all domains assessed, including access to health care, mental and emotional health, ability to meet basic needs, finances, and social support. Impacts varied by demographic and clinical characteristics. The participants most negatively impacted by the pandemic were younger, Black or Latino, female, more educated, and unemployed and had screened positive for depression. No impact differences were found with regard to alcohol use disorder screenings or a prior history of COVID-19. Higher levels of pain were associated with worse pandemic impacts, and negative impacts declined over time.ConclusionsNegative impacts of the pandemic on individuals living with chronic pain cut across aspects of life that are also central to effective pain management, including access to health care, social support, and mental and emotional health, with differential impacts found across key demographic and clinical factors. These findings should yield consideration of pandemic impacts in clinical practice and as moderating effects of treatment outcomes in clinical trials conducted during the pandemic

Association of influenza vaccine uptake with health, access to health care, and medical mistreatment among adults from low-income neighborhoods in New Haven, CT: a classification tree analysis

Objective To identify population subgroups under-vaccinated for influenza through classification tree analysis to inform interventions aimed at improving future vaccine uptake. Method A cross-sectional community health needs assessment was conducted from 09/2012 through 11/2012 among randomly selected households in six low-income neighborhoods in New Haven, CT (N=1300 adults, aged 18-65). Known correlates of influenza vaccine uptake plus experience of medical mistreatment were used to develop a classification tree to identify under-vaccinated population subgroups Results Forty-five percent of respondents reported receiving the influenza vaccine. The classification tree identified healthy adults and uninsured adults at increased risk of influenzacomplications as subgroups with low vaccine uptake (40% and 30%, respectively). The subgroup representing insured, high-risk adults who reported experience of medical mistreatment had moderate vaccine uptake (45%). Sensitivity of the classification tree was high (83%, 95% CI= 80% to 86%), indicating a strong true positive rate using these subgroups. Conclusion Results highlight the need for renewed attention to promoting the influenza vaccination recommendation for all adults, particularly among healthy adults, uninsured, high-risk adults and insured, high-risk adults who have experienced medical mistreatment. Further research is needed to better understand how to reach these population subgroups

Comparison of Use of the Massachusetts Child Psychiatry Access Program and Patient Characteristics Before vs During the COVID-19 Pandemic

This cross-sectional study compares the number of encounters at the Massachusetts Child Psychiatry Access Program, patient characteristics, and mental health diagnoses before vs during the COVID-19 pandemic

Progression of depression and anxiety symptoms in pregnancies conceived by assisted reproductive technology in the United States

Purpose Women who utilize assisted-reproductive technology (ART) to achieve pregnancy experience unique circumstances before and during their pregnancy. This study aims to examine the progression of mental health in pregnant women who conceived via various methods of ART to understand gestational time periods of emotional stability or risk specific to these populations. Methods Secondary analysis of the Yale Pink and Blue Study – a prospective cohort involving women from 137 obstetrical practices in the northeastern United States between 2005–2009. Depressive and anxiety symptoms among spontaneous, planned pregnancies were compared to ART pregnancies using the Edinburgh Postnatal Depression Scale (EPDS) and its anxiety subscale (EPDS-3A), respectively. Generalized Estimating Equations were used to compare group changes (EPDS and EPDS-3A score threshold ≥10) at timepoints of <17 weeks (T1), 28(±2) weeks (T2), and 8(±4) weeks postpartum (T3). Results 1,466 spontaneous, planned pregnancies were compared to 191 pregnancies conceived via ART. Prevalence of depressive symptoms were similar between conception groups. Change in prevalence over time differed significantly between those groups (from T1 to T3 (β 0.59), as well as between spontaneous pregnancies compared to autologous gamete ART pregnancies (from T1 to T2 (β 0.48) and T1 to T3 (β 0.65). Course of anxiety did not differ between conception groups. Conclusions Women who conceive via ART have different rates of change in depressive symptoms throughout gestation compared to women with spontaneous pregnancies

Comparing Satisfaction, Alliance and Intervention Components in Electronically Delivered and In-person Brief Interventions for Substance Use Among Childbearing-Aged Women

Electronic delivery of Screening, Brief Intervention, and Referral to Treatment (e-SBIRT) may be a low-cost and high-reach method for screening and brief intervention in health care settings. However, its relative acceptability, ability to build a therapeutic alliance, and delivery of key intervention components compared to in-person SBIRT (SBIRT) is unclear. The association of these factors with intervention outcomes is also not known. We compared SBIRT and e-SBIRT on satisfaction, alliance, and receipt of intervention components, and evaluated the extent to which these intervention dimensions were related to later substance use. Data were collected as part of a randomized clinical trial (N = 439) examining SBIRT, e-SBIRT, and enhanced usual care for childbearing-aged women in two reproductive healthcare clinics (see Martino et al. (2018) for main trial findings). Participants receiving SBIRT or e-SBIRT (N = 270) rated satisfaction and alliance following a single-session, brief intervention, based on motivational interviewing that targeted hazardous substance use (tobacco, alcohol, illicit drugs and prescribed medications). Trained raters coded audio-recorded SBIRT sessions for the presence of six major intervention components, and evaluated the occurrence of these components in the e-SBIRT software. Overall, participants in both groups reported strong satisfaction (on average, “considerably” to “extremely” satisfied) and perceived working alliance (on average, “very often” to “always” allied). SBIRT participants provided higher overall alliance ratings, felt more encouraged to make their own decisions, and rated the intervention\u27s likely helpfulness to other women higher. Fewer e-SBIRT participants received intervention components focusing on personalized feedback, developing importance of and confidence in making changes to substance use, and developing a plan to change, compared to SBIRT participants. However, e-SBIRT participants were equally or more likely to receive components seeking to help them understand their use, discussing reasons for use, and summarizing and supporting what the patients elected to do. Notably, satisfaction, alliance, and number of intervention components received were not associated with total days of substance use. Although we found no evidence that the intervention characteristics evaluated in this study were associated with outcomes, acceptability and alliance may have other important implications. Findings suggest areas for improvement with respect to e-SBIRT satisfaction and alliance formation. ClinicalTrials.gov registration number: NCT0153952