ABSTRACT
BACKGROUND: Anxiety and depression are common in the perinatal period and negatively affect the health of the mother and baby. Our group has developed "Happy Mother-Healthy Baby" (HMHB), a cognitive behavioral therapy-based psychosocial intervention to address risk factors specific to anxiety during pregnancy in low- and middle-income countries (LMICs). OBJECTIVE: The purpose of this study is to examine biological mechanisms that may be linked to perinatal anxiety in conjunction with a randomized controlled trial of HMHB in Pakistan. METHODS: We are recruiting 120 pregnant women from the Holy Family Hospital, a public facility in Rawalpindi, Pakistan. Participants are assessed for at least mild anxiety symptoms using the Hospital Anxiety and Depression Scale (ie, a score ≥8 on the anxiety scale is necessary for inclusion in the anxiety groups and <8 for inclusion in the healthy control group). Women who meet the criteria for an anxiety group are randomized into either the HMHB intervention group or an enhanced usual care (EUC) control group. Participants receive HMHB or EUC throughout pregnancy and undergo blood draws at 4 time points (baseline, second trimester, third trimester, and 6 weeks post partum). We will assess peripheral cytokine concentrations using a multiplex assay and hormone concentrations using gas chromatography and mass spectrometry. The statistical analysis will use generalized linear models and mixed effects models to assess the relationships across time among anxiety, immune dysregulation, and hormone levels, and to assess whether these biological factors mediate the relationship between anxiety and birth and child development outcomes. RESULTS: Recruitment started on October 20, 2020, and data collection was completed on August 31, 2022. The start date for recruitment for this biological supplement study was delayed by approximately half a year due to the COVID-19 pandemic. The trial was registered at ClinicalTrials.gov (NCT03880032) on September 22, 2020. The last blood samples were shipped to the United States on September 24, 2022, where they will be processed for analysis. CONCLUSIONS: This study is an important addition to the HMHB randomized controlled trial of an intervention for antenatal anxiety. The intervention itself makes use of nonspecialist providers and, if effective, will represent an important new tool for the treatment of antenatal anxiety in LMICs. Our biological substudy is one of the first attempts to link biological mechanisms to antenatal anxiety in an LMIC in the context of a psychosocial intervention, and our findings have the potential to significantly advance our knowledge of the biological pathways of perinatal mental illness and treatment efficacy. TRIAL REGISTRATION: ClinicalTrials.gov NCT03880032; https://clinicaltrials.gov/ct2/show/NCT03880032. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43193.
ABSTRACT
BACKGROUND: The COVID-19 pandemic has exacerbated historical inequities for people with disabilities including barriers in accessing online information and healthcare appointment websites. These barriers were brought to the foreground during the vaccine rollout and registration process. OBJECTIVE: This cross-sectional study aimed to examine accessibility of U.S. state and territory COVID-19 information and registration centralized websites. METHODS: The Johns Hopkins Disability Health Research Center created a COVID-19 Vaccine Dashboard compiling COVID-19 information and vaccine registration web pages from 56 states and territories in the United States (U.S.) reviewed between March 30 through April 5, 2021 and analyzed accessibility using WAVE Web Accessibility Evaluation Tool (WAVE). WAVE identifies website accessibility barriers, including insufficient contrast, alternative text, unlabeled buttons, total number of errors, and error density. Web pages were ranked and grouped into three groups by number of errors, creating comparisons between states on accessibility barriers for people with disabilities. RESULTS: All 56 U.S states and territories had COVID-19 information web pages and 29 states had centralized state vaccine registration web pages. Total errors, error density, and alert data were utilized to generate accessibility scores for each web page, the median score was 259 (range = 14 to 536 and IQR = 237) for information pages, and 146 (range = 10 to 281 and IQR = 105) for registration pages. CONCLUSIONS: These results highlight barriers people with disabilities may encounter when accessing information and registering for the COVID-19 vaccine, which underscore inequities in the pandemic response for the disability community and elevate the need to prioritize accessibility of public health information.