Study protocol: A randomized controlled trial of Raising Our Spirits Together, an entertaining, group-based technology-assisted cognitive behavioral therapy for depression, tailored for rural adults and delivery by clergy.

This paper presents a methodological description of a randomized controlled trial (RCT) testing the effect of Raising Our Spirits Together (ROST), a technology-assisted cognitive behavioral therapy (T-CBT) for depression, tailored for the rural context and for delivery by clergy, compared to an enhanced control condition. Depression is among the most common mental health conditions; yet the majority of adults with depression do not receive needed treatment due to limited access to mental health professionals, treatment-associated costs, distance to care, and stigma. These barriers are particularly salient in rural areas of the United States. T-CBT with human support is an accessible and effective treatment for depression; however, currently available T-CBTs have poor completion rates due to the lack of tailoring and other features to support engagement. ROST is a T-CBT specifically tailored for the rural setting and delivery by clergy, who are preferred, informal providers. ROST also presents core CBT content in a simple, jargon-free manner that supports multiple learning preferences. ROST is delivered virtually in a small group format across 8 weekly sessions via videoconferencing software consistent with other clergy-based programs, such as Bible studies or self-help groups. In this study, adults with depressive symptoms recruited from two rural Michigan counties will be randomized to receive ROST versus an enhanced control condition (N = 84). Depressive symptoms post-treatment and at 3 months follow-up according to the Patient Health Questionnaire (PHQ-9) will be the primary outcome. Findings will determine whether ROST is effective for improving depression symptoms in underserved, under resourced rural communities.

Technology-Assisted, Group-Based CBT for Rural Adults' Depression: Open Pilot Trial Results.

Purpose: This pilot study assesses the association of Raising Our Spirits Together (ROST), a technology-assisted, group-based cognitive behavioral therapy for depression, with rural adults' depressive symptoms and anxiety. Method: Nine adults from rural Michigan participated in an open pilot of ROST. Clergy facilitated pilot groups. The pilot began in February 2020 in-person. Due to COVID-19, the pilot was completed virtually. Results: Mean depressive symptom scores, based on the PHQ-9, significantly decreased from pre-treatment (M = 14.4) to post-treatment (M = 6.33; t (8) = 6.79; P < .001). Symptom reduction was maintained at 3-month follow-up (M = 8.00), with a significant pattern of difference in depressive symptoms over time (F(2) = 17.7; P < .001; eta-squared = .689). Similar patterns occurred for anxiety based on the GAD-7. Participants attended an average of 7.33 of 8 sessions. Fidelity ratings were excellent. Discussion: ROST is a potentially feasible intervention for rural adults' depressive symptoms. ROST offers a promising model for increasing treatment access and building capacity in rural areas.

Rural Residents' Depressive Symptoms and Help-Seeking Preferences: Opportunities for Church-Based Intervention Development.

This study examines rural residents' depressive symptoms, helps seeking preferences and perceptions of a church-based group depression intervention, informing feasibility of adapting evidence-based treatment for delivery in rural churches. A cross-sectional survey was administered to 100 members of 2 churches in a rural Midwestern community; 63 congregants responded. Depression was assessed via the Patient Health Questionnaire-9. Descriptive analyses were performed, and 12.9% of respondents screened positive for depression. Another 25% reported mild symptomatology. Respondents preferred informal help seeking, although reported more openness to formal providers to address others' depression. Results suggest receptivity to church-based treatment. Almost two-third of respondents reported they would consider attending a church-based group depression intervention, 80% would recommend it to a friend in need, and 60% indicated it would benefit their community. Delivering evidence-based depression treatment within church settings may provide a viable option for increasing access to care in this rural community.

Intranasal delivery of a bivalent norovirus vaccine formulated in an in situ gelling dry powder.

The global health community is beginning to understand the burden of norovirus-associated disease, which has a significant impact in both developed and developing countries. Norovirus virus like particle (VLP)-based vaccines are currently under development and have been shown to elicit systemic and mucosal immune responses when delivered intranasally. In the present study, we describe the use of a dry powder formulation (GelVac™) with an in situ gelling polysaccharide (GelSite™) extracted from Aloe vera for nasal delivery of a bivalent vaccine formulation containing both GI and GII.4 norovirus VLPs. Dose-ranging studies were performed to identify the optimal antigen dosages based on systemic and mucosal immune responses in guinea pigs and determine any antigenic interference. A dose-dependent increase in systemic and mucosal immunogenicity against each of the VLPs were observed as well as a boosting effect for each VLP after the second dosing. A total antigen dose of ≥50 µg of each GI and GII.4 VLPs was determined to be the maximally immunogenic dose in guinea pigs. The immunogenicity results of this bivalent formulation, taken together with previous work on monovalent GelVac™ norovirus vaccine formulation, provides a basis for future development of this norovirus VLP vaccine.

Preclinical dose-ranging studies of a novel dry powder norovirus vaccine formulation.

Norovirus is the primary cause of viral gastroenteritis in humans with multiple genotypes currently circulating worldwide. The development of a successful norovirus vaccine is contingent on its ability to induce both systemic and mucosal antibody responses against a wide range of norovirus genotypes. Norovirus virus-like particles (VLPs) are known to elicit systemic and mucosal immune responses when delivered intranasally. Incorporation of these VLPs into an intranasal powder vaccine offers the advantage of simplicity and induction of neutralizing systemic and mucosal antibodies. Nasal immunization, which provides the advantage of ease of administration and a mucosal delivery mechanism, faces the real issue of limited nasal residence time due to mucociliary clearance. Herein, we describe a novel dry powder (GelVac™) formulation of GI or GII.4 norovirus VLPs, two dominant circulating genotypes, to identify the optimal antigen dosages based on systemic and mucosal immune responses in guinea pigs. Systemic and mucosal immunogenicity of each of the VLPs was observed in a dose-dependent manner. In addition, a boosting effect was observed after the second dosing of each VLP antigen. With the GelVac™ formulation, a total antigen dose of ≥ 15 µg was determined to be the maximally immunogenic dose for both GI and GII.4 norovirus VLPs based on evaluation for 56 days. Taken together, these results indicate that norovirus VLPs could be used as potential vaccine candidates without using an immunostimulatory adjuvant and provide a basis for the development of a GelVac™ bivalent GI/GII.4 norovirus VLP vaccine.

Identification and application of AFLP-derived genetic markers for quantitative PCR-based tracking of Bacillus and Paenibacillus spp. released in soil.

In this study, we show that noncoding sequences from amplified fragment length polymorphisms (AFLPs) can provide robust and sensitive genetic markers suitable for PCR-based discrimination of closely related strains of Bacillus and Paenibacillus, and quantitative PCR (qPCR)-based tracking of the strains in complex natural systems like soil. Quantitative PCR was accurate in the approximately 1 x 10(9) to approximately 1 x 10(4) colony forming units (CFU)/g soil range. The detection limit was improved to approximately 1 x 10(2) CFU/g when amplicons were analyzed by gel electrophoresis. Studies with laboratory-contained intact soil-core microcosms indicated that environmental persistence trends vary among different strains. For example, Bacillus circulans ATCC 9500, Bacillus amyloliquefaciens DSL 13563-0, Bacillus licheniformis ATCC 12713, Paenibacillus polymyxa NRRL B-4317, and 3 Bacillus subtilisstrains (ATCC 6051A, ATCC 55405, and NRRL B-941) died down to below the 1 x 10(2) CFU/g detection limit by days 28-105. In contrast, over a 105-day period, B. licheniformis ATCC 55406, Bacillus megaterium NRRL B-14308, and P. polymyxa strains ATCC 55407 and DSL 13540-4 died down but persisted at levels just above the detection limit, whereas Bacillus thuringiensis ATCC 13367 experienced a less than 10-fold decrease in cell numbers.

A community-wide perspective into changing trends in the utilization of diagnostic and interventional procedures in patients hospitalized with acute myocardial infarction.

BACKGROUND: Limited data are available describing contemporary trends in the utilization of diagnostic and interventional procedures in patients hospitalized with acute myocardial infarction (AMI). The objectives of our population-based investigation were to examine long-term trends (1986-2003) in the utilization of cardiac catheterization, percutaneous coronary interventions (PCI), and coronary artery bypass graft surgery (CABG) in a community sample of patients hospitalized with AMI. We examined the demographic and clinical characteristics of patients who received these diagnostic and interventional procedures and determined whether the profile of patients undergoing these procedures had changed over time. METHODS: The study sample consisted of 9422 greater Worcester (MA) residents hospitalized with confirmed AMI at all metropolitan Worcester medical centers in 10 annual periods between 1986 and 2003. Information on patient demographics, clinical course, and treatment practices was obtained through the review of hospital medical records. RESULTS: Marked increases were observed in the utilization of cardiac catheterization (18.4% to 55.8%) and PCI (2.0% to 42.1%) between 1986 and 2003, respectively. Utilization of CABG showed modest increases in the early 1990s, whereas its use was relatively stable thereafter. Several demographic and clinical characteristics were associated with the receipt of these diagnostic and interventional procedures. CONCLUSIONS: The results of this study of patients hospitalized with AMI in a large New England community suggest evolving trends in the use of cardiac catheterization, PCI, and CABG. Despite these changing patterns, our findings suggest that there remains room for improvement in the therapeutic management of patients hospitalized with AMI, including certain high-risk groups.

Novel use of the BD FACS SPA to automate custom monoclonal antibody panel preparations for immunophenotyping.

BACKGROUND: The effective and accurate diagnosis of hematologic malignancies relies on flow cytometric immunophenotyping. Selected combinations of monoclonal antibodies (mAbs) arranged in multicolor panels allow for the accurate definition of normal and abnormal hematologic cell populations. The most time-consuming and crucial step in the staining process involves dispensing combinations of multiple mAbs into their appropriate staining tubes. This step is prone to error, requires concentration and accuracy, and is dependent on technologist experience. The Becton Dickinson BioScience (BD) FACS Sample Prep Assistant (SPA) is touted as a breakthrough in automated in vitro diagnostic sample preparation. The SPA is designed to automate BD MultiTESk and BD TriTest lyse/no-wash assays. However, because most cases in our laboratory require tedious application of unique four-color mAb cocktails for leukemia and lymphoma testing, we wondered whether the SPA would be helpful in accurately dispensing these mixtures. METHODS: The mAb panels were prepared by the SPA in two separate timed runs and on separate days. Eleven specimens (nine from patients and two from normal volunteers) were split and stained with four-color cocktails created by the SPA or manually. The percentage of positive (%P) cells and mean fluorescent intensity for each mAb pair were determined. These values were plotted against each other and correlation values were calculated. To quantitate timesaving in the laboratory, two technologists prepared individually the same mAb panels and were timed. RESULTS: The correlation between the two methods was high; r(2) was 0.988 for 158 %P antigen pairs; no bias between the manual and robotic methods was detected with the Wilcoxon rank test. Bland-Altman analysis indicated no obvious relation between the difference and the mean of %P cells, suggesting that the SPA successfully dispensed antibodies for leukemia/lymphoma panels. The two methods may be interchangeable, although the limited sample size prohibits this conclusion from Bland-Altman statistics alone. In addition, one possible error was detected in the SPA-prepared panels. The SPA averaged 65 min/run, the experienced technologist 12.95 min/run, and the inexperienced technologist 54.9 min/run. CONCLUSIONS: SPA dispensing time was twice the average manual dispensing time; however, SPA use was completely automated and freed the technologist to perform other tasks. SPA use permitted preemptive preparation of mAb panels and thus streamlined processing; however, the cost of the assay and the amount of reagent waste increased. It is certain that software modifications by BD could decrease the SPA reagent dispense time and decrease the cost associated with reagent waste when the SPA is used in this novel fashion.