A randomized trial of acceptance-based behavioral therapy to improve mental health outcomes for LGBTQ+ persons: Study protocol.

BACKGROUND: During the COVID-19 pandemic, public health measures limited social interactions as an effective and protective intervention for all. For many, however, this social isolation exacerbated mental health symptoms. People who identify as lesbian, gay, bisexual, transgender, and queer (LGBTQ+) were already at elevated risk of anxiety and depression, relative to cisgender and heterosexual populations, and pandemic-related social isolation likely heightened these disparities. In our prior work with sexual and gender minorities, we developed and established feasibility and acceptability of a novel acceptance-based behavioral therapy (ABBT) intervention for HIV treatment. ABBT showed promise in improving social support and reducing mental health symptoms. In the current study, we investigate the efficacy of ABBT, compared to a treatment-as-usual control condition, in a full-scale randomized controlled trial to improve social support for LGBTQ+ persons living with anxiety and depression. METHODS: Two hundred forty LGBTQ+ adults with anxiety and/or depressive symptoms will be recruited and equally randomized to receive: (a) the ABBT intervention, consisting of two 30-40 min sessions plus treatment-as-usual (TAU), or (b) TAU only. Primary outcomes are interviewer-assessed anxiety and depressive symptoms. Secondary outcomes are self-reported anxiety and depressive symptoms. Experiential avoidance and social support are hypothesized mediators and presence of an anxiety and/or depressive disorder is a hypothesized moderator. CONCLUSIONS: ABBT represents a novel, identify-affirming real-world approach to promoting social support as a means of improving mental health among individuals who identify as LGBTQ+. This study will contribute actionable data establishing the impact, mediational mechanisms, and effect modifiers of ABBT. CLINICALTRIALS: govregistration: NCT05540067.

A Perspective on Implementation Outcomes and Strategies to Promote the Uptake of COVID-19 Vaccines

Recent articles have highlighted the importance of incorporating implementation science concepts into pandemic-related research. However, limited research has been documented to date regarding implementation outcomes that may be unique to COVID-19 vaccinations and how to utilize implementation strategies to address vaccine program-related implementation challenges. To address these gaps, we formed a global COVID-19 implementation workgroup of implementation scientists who met weekly for over a year to review the available literature and learn about ongoing research during the pandemic. We developed a hierarchy to prioritize the applicability of "lessons learned” from the vaccination-related implementation literature. We identified applications of existing implementation outcomes as well as identified additional implementation outcomes. We also mapped implementation strategies to those outcomes. Our efforts provide rationale for the utility of using implementation outcomes in pandemic-related research. Furthermore, we identified three additional implementation outcomes: availability, health equity, and scale-up. Results include a list of COVID-19 relevant implementation strategies mapped to the implementation outcomes.

A Perspective on Implementation Outcomes and Strategies to Promote the Uptake of COVID-19 Vaccines.

Recent articles have highlighted the importance of incorporating implementation science concepts into pandemic-related research. However, limited research has been documented to date regarding implementation outcomes that may be unique to COVID-19 vaccinations and how to utilize implementation strategies to address vaccine program-related implementation challenges. To address these gaps, we formed a global COVID-19 implementation workgroup of implementation scientists who met weekly for over a year to review the available literature and learn about ongoing research during the pandemic. We developed a hierarchy to prioritize the applicability of "lessons learned" from the vaccination-related implementation literature. We identified applications of existing implementation outcomes as well as identified additional implementation outcomes. We also mapped implementation strategies to those outcomes. Our efforts provide rationale for the utility of using implementation outcomes in pandemic-related research. Furthermore, we identified three additional implementation outcomes: availability, health equity, and scale-up. Results include a list of COVID-19 relevant implementation strategies mapped to the implementation outcomes.

Antecedents to COVID-19 vaccine uptake among patients and employees in the Veterans Health Administration.

The present study sought to understand the antecedents to COVID-19 vaccination among those reporting a change in vaccine intention in order to improve COVID-19 vaccine uptake in the United States. We employed semi-structured interviews and one focus group discussion with vaccinated and unvaccinated Veterans Health Administration (VHA) employees and Veterans at three Veterans' Affairs medical centers between January and June 2021. A subset of these participants (n=21) self-reported a change in COVID-19 vaccine intention and were selected for additional analysis. We combined thematic analysis using the 5C scale (confidence, collective responsibility, complacency, calculation, constraints) as our theoretical framework with a constant comparative method from codes based on the SAGE Working Group on Vaccine Hesitancy. We generated 13 themes distributed across the 5C constructs that appeared to be associated with a change in COVID-19 vaccine intention. Themes included a trusted family member, friend or colleague in a healthcare field, a trusted healthcare professional, distrust of government or politics (confidence); duty to family and protection of others (collective responsibility); perceived health status and normative beliefs (complacency); perceived vaccine safety, perceived risk-benefit, and orientation towards deliberation (calculation); and ease of process (constraints). Key factors in promoting vaccine uptake included a desire to protect family; and conversations with as key factors in promoting vaccine uptake. Constructs from the 5C scale are useful in understanding intrapersonal changes in vaccine intentions over time, which may help public health practitioners improve future vaccine uptake.

In this study of the Veteran and VA employee population, we aimed to understand what factors led to a decision to receive a COVID-19 vaccine. As part of a quality improvement project, we interviewed individuals at three Veterans' Affairs sites in the first six months of 2021. We then used a smaller sample of 21 participants who reported a change in their intentions to receive a COVID-19 vaccine to analyze for this study. This analysis utilizes constructs from the 5C scale, which was developed to understand the conditions required for an individual to decide to receive a vaccine (confidence, collective responsibility, complacency, calculation, constraints). The coding process revealed a number of recurring themes across the interviews falling under each of the five constructs, but concepts relating to vaccine confidence (i.e., level of trust in those developing and disseminating the vaccine) were most common, and constraints (i.e., psychological and structural barriers that stand in the way of vaccination) appeared least frequently in our interviews. We found that significant motivators to receive the vaccine included a desire to protect family and conversations with trusted clinicians, particularly mental healthcare providers. Our study was unique in using the 5Cs to understand changes in vaccine changes over time. Findings show that change in vaccine attitudes is possible even in the presence of concerns and shed light on approaches that public health providers could use to improve vaccine and booster rates.

Creating Connections during COVID-19.

Our research group created a public communication strategy of expressive writing, to use within our research center over the Massachusetts COVID-19 stay at home advisories. Our goals were to 1) build community, 2) recognize the unique experiences, needs, concerns and coping strategies of our colleagues, and 3) create a mechanism to creatively share those experiences. We conceptualized a weekly e-newsletter, "Creativity in the Time of COVID-19," a collective effort for expressing and documenting the extraordinary, lived experiences of our colleagues during this unique time of a coronavirus pandemic. Through 23 online issues, we have captured 72 colleagues' perspectives on social isolation, the challenges of working from home, and hope in finding connection through virtual platforms. We have organized the themes of these submissions, in the forms of photos, essays, poetry, original artwork, and more, according to three components of the Social Connection Framework: structural, functional and quality approaches to creating social connectedness.

Examining Pregnant Veterans' Acceptance and Beliefs Regarding the COVID-19 Vaccine.

BACKGROUND: Pregnant persons have received mixed messages regarding whether or not to receive COVID-19 vaccines as limited data are available regarding vaccine safety for pregnant and lactating persons and breastfeeding infants. OBJECTIVE: The aims of this study were to examine pregnant Veteran's acceptance of COVID-19 vaccines, along with perceptions and beliefs regarding vaccine safety and vaccine conspiracy beliefs. DESIGN AND PARTICIPANTS: We conducted a cross-sectional survey of pregnant Veterans enrolled in VA care who were taking part in an ongoing cohort study at 15 VA medical centers between January and May 2021. MAIN MEASURES: Pregnant Veterans were asked whether they had been offered the COVID-19 vaccine during pregnancy, and whether they chose to accept or refuse it. Additional questions focused on perceptions of COVID-19 vaccine safety and endorsements of vaccine knowledge and conspiracy beliefs. Logistic regression was utilized to examine predictors of acceptance of a vaccine during pregnancy. KEY RESULTS: Overall, 72 pregnant Veterans were offered a COVID-19 vaccine during pregnancy; over two-thirds (69%) opted not to receive a vaccine. Reasons for not receiving a vaccine included potential effects on the baby (64%), side effects for oneself (30%), and immunity from a past COVID-19 infection (12%). Those who received a vaccine had significantly greater vaccine knowledge and less belief in vaccine conspiracy theories. Greater knowledge of vaccines in general (aOR: 1.78; 95% CI: 1.2-2.6) and lower beliefs in vaccine conspiracies (aOR: 0.76; 95% CI: 0.6-0.9) were the strongest predictors of acceptance of a COVID-19 vaccine during pregnancy. CONCLUSIONS: Our study provides important insights regarding pregnant Veterans' decisions to accept the COVID-19 vaccine, and reasons why they may choose not to accept the vaccine. Given the high endorsement of vaccine conspiracy beliefs, trusted healthcare providers should have ongoing, open discussions about vaccine conspiracy beliefs and provide additional information to dispel these beliefs.

The Strategies for Quantitative and Qualitative Remote Data Collection: Lessons From the COVID-19 Pandemic.

The COVID-19 pandemic has necessitated a rapid shift to web-based or blended design models for both ongoing and future clinical research activities. Research conducted virtually not only has the potential to increase the patient-centeredness of clinical research but may also further widen existing disparities in research participation among underrepresented individuals. In this viewpoint, we discuss practical strategies for quantitative and qualitative remote research data collection based on previous literature and our own ongoing clinical research to overcome challenges presented by the shift to remote data collection. We aim to contribute to and catalyze the dissemination of best practices related to remote data collection methodologies to address the opportunities presented by this shift and develop strategies for inclusive research.

Redesign of a brief PTSD treatment in safety net integrated primary care: Supporting implementation in the context of the COVID-19 pandemic.

OBJECTIVE: We conducted a formative evaluation to understand the impact of the COVID-19 pandemic on the safety net integrated primary care setting and to identify (and respond to) new implementation barriers prior to a hybrid type I effectiveness-implementation trial of a posttraumatic stress disorder (PTSD) treatment. METHOD: We used surveys and qualitative interviews with employee stakeholders (N = 27) to (1) understand pandemic-related factors that may influence implementation, including changes in patient needs, provider experiences, and the practice, and (2) assess the need for augmentation to study design, implementation plan, or intervention. RESULTS: Conventional content analysis and survey findings suggest that patient acuity and volume increased provider burden, leading to high burnout. Although the shift to telehealth improved behavioral health access, issues with technology access and literacy were common. Changes to the study design and implementation plan, based on findings, included the provision of multi-modality treatments (in person, telehealth, web-administered), technology and administrative support, and other strategies for reducing provider burnout. CONCLUSIONS: This study describes how an ongoing research study adapted to major changes to the implementation setting during the pandemic. Changes to study design and implementation plan were responsive to the shift to telehealth and therapist burden (and burnout) concerns.

Attitudes and Intentions of US Veterans Regarding COVID-19 Vaccination.

Importance: Compared with the general population, veterans are at high risk for COVID-19 and have a complex relationship with the government. This potentially affects their attitudes toward receiving COVID-19 vaccines. Objective: To assess veterans' attitudes toward and intentions to receive COVID-19 vaccines. Design, Setting, and Participants: This cross-sectional web-based survey study used data from the Department of Veterans Affairs (VA) Survey of Healthcare Experiences of Patients' Veterans Insight Panel, fielded between March 12 and 28, 2021. Of 3420 veterans who were sent a link to complete a 58-item web-based survey, 1178 veterans (34%) completed the survey. Data were analyzed from April 1 to August 25, 2021. Exposures: Veterans eligible for COVID-19 vaccines. Main Outcomes and Measures: The outcomes of interest were veterans' experiences with COVID-19, vaccination status and intention groups, reasons for receiving or not receiving a vaccine, self-reported health status, and trusted and preferred sources of information about COVID-19 vaccines. Reasons for not getting vaccinated were classified into categories of vaccine deliberation, dissent, distrust, indifference, skepticism, and policy and processes. Results: Among 1178 respondents, 974 (83%) were men, 130 (11%) were women, and 141 (12%) were transgender or nonbinary; 58 respondents (5%) were Black, 54 veterans (5%) were Hispanic or Latino, and 987 veterans (84%) were non-Hispanic White. The mean (SD) age of respondents was 66.7 (10.1) years. A total of 817 respondents (71%) self-reported being vaccinated against COVID-19. Of 339 respondents (29%) who were not vaccinated, those unsure of getting vaccinated were more likely to report fair or poor overall health (32 respondents [43%]) and mental health (33 respondents [44%]) than other nonvaccinated groups (overall health: range, 20%-32%; mental health: range, 18%-40%). Top reasons for not being vaccinated were skepticism (120 respondents [36%] were concerned about side effects; 65 respondents [20%] preferred using few medications; 63 respondents [19%] preferred gaining natural immunity), deliberation (74 respondents [22%] preferred to wait because vaccine is new), and distrust (61 respondents [18%] did not trust the health care system). Among respondents who were vaccinated, preventing oneself from getting sick (462 respondents [57%]) and contributing to the end of the COVID-19 pandemic (453 respondents [56%]) were top reasons for getting vaccinated. All veterans reported the VA as 1 of their top trusted sources of information. The proportion of respondents trusting their VA health care practitioner as a source of vaccine information was higher among those unsure about vaccination compared with those who indicated they would definitely not or probably not get vaccinated (18 respondents [26%] vs 15 respondents [15%]). There were no significant associations between vaccine intention groups and age (χ24 = 5.90; P = .21) or gender (χ22 = 3.99; P = .14). Conclusions and Relevance: These findings provide information needed to develop trusted messages used in conversations between VA health care practitioners and veterans addressing specific vaccine hesitancy reasons, as well as those in worse health. Conversations need to emphasize societal reasons for getting vaccinated and benefits to one's own health.

Protocol for the Rhode Island CORD 3.0 Study: Adapting, Testing, and Packaging the JOIN for ME Family-Based Childhood Obesity Program in Low-Income Communities.

Background: Overweight and obesity in children is a public health crisis in the United States. Although evidence-based interventions have been developed, such programs are difficult to access. Dissemination of evidence-based pediatric weight management interventions (PWMIs) to families from diverse low-income communities is the primary objective of the CDC Childhood Obesity Research Demonstration (CORD) projects. Methods: The goal of the Rhode Island CORD 3.0 project is to adapt the evidence-based PWMI, JOIN for ME, for delivery among diverse families from low-income backgrounds and to test it in a hybrid effectiveness-implementation trial design in which the aims are to examine implementation and patient-centered outcomes. Children between the ages of 6 and 12 years with BMI ≥85th percentile and a caregiver will be recruited through two settings, a federally qualified health center, which serves as a patient-centered medical home, or low-income housing. Dyads will receive a remotely delivered group-based intervention that is 10 months in duration and includes 16 weekly sessions, followed by 4 biweekly and 4 monthly meetings. Assessments of child and caregiver weight status and child health-related quality of life will be conducted at baseline, and at 4 and 10 months after the start of intervention. Implementation outcomes assessing intervention acceptability, adoption, feasibility, fidelity, and penetration/reach will be collected to inform subsequent dissemination. Conclusions: If the adapted version of the JOIN for ME intervention can be successfully implemented and is shown to be effective, this project will provide a model for a scalable PWMI for families from low-income backgrounds. ClinicalTrials.gov no. NCT04647760.

Vaccine hesitancy as an opportunity for engagement: A rapid qualitative study of patients and employees in the U.S. Veterans Affairs healthcare system.

Although COVID-19 vaccines have been available to many U.S. Veterans Affairs (VA) healthcare system employees and Veteran patients since early 2021, vaccine receipt data indicates some groups are not receiving them. Our objective was to conduct a rapid qualitative assessment of Veterans' and VA employees' views on COVID-19 vaccination to inform clinical leaders' ongoing efforts to increase vaccine uptake across the VA. We employed semi-structured interviews and a focus group involving employees and Veterans as part of a quality improvement project between January and June 2021 at three VA medical centers. Thirty-one employees and 27 Veterans participated in semi-structured interviews; 5 Veterans from a national stakeholder organization participated in a focus group. Data were analyzed using directed content analysis, involving an a priori coding framework comprised of four domains with subcodes under each: contextual influences, barriers and facilitators, vaccine-specific issues, and VA/military experiences. We then classified initial codes into five categories of hesitancy: vaccine deliberation, dissent, distrust, indifference and skepticism. A subset of Veterans (n = 14) and employees (n = 8) identified as vaccine hesitant. Vaccine hesitancy categories were represented by subcodes of religion, culture, gender or socio-economic factors, perceptions of politics and policies, role of healthcare providers, and historical influences; (contextual influences); knowledge or awareness of vaccines, perceived susceptibility to COVID-19, and beliefs and attitudes about health and illness (barriers and facilitators); vaccine development process (vaccine-specific issues) and military experiences (VA/military factors). Facilitators involved talking with trusted others, ease of vaccine access, and perceptions of family and societal benefits of vaccines. Vaccine hesitancy is multi-faceted and likely requires multiple strategies for engaging in conversations to address Veteran and VA employee concerns. Messages should involve patient-centered communication strategies delivered by trusted healthcare providers and peers and should focus on addressing expected benefits for family, friends, and society.

Bringing New Meaning to the Term "Adaptive Trial": Challenges of Conducting Clinical Research During the Coronavirus Disease 2019 Pandemic and Implications for Implementation Science.

Although implementation of evidence-based practices takes an average of 17 years, in the context of the global pandemic, coronavirus disease 2019 (COVID-19) interventions were adopted in a greatly compressed time frame. This rapid uptake creates major challenges for conducting COVID-19 clinical research studies, because quickly evolving standards make it difficult to adapt in real time. The rapid dissemination and implementation of COVID-19 interventions is the realization of goals long pursued by the implementation science community. However, the downside of the rapid implementation is that low-quality evidence with little to no scientific vetting may be quickly integrated into clinical care, resulting in lost opportunities to advance our scientific understanding about how to manage infected patients. In the future, novel adaptive designs embedded into electronic health records (Embedded Quantified, Integrated-into-Practice Trial [EQuIPT] designs) that allow for easier and better access to clinical trials may simultaneously improve care and advance healthcare innovations.