Public mental health during and after the SARS-CoV-2 pandemic: Opportunities for intervention via emotional self-efficacy and resilience.

Importance: During the pandemic, the number of United States adults reporting clinically significant symptoms of anxiety and depression sky-rocketed, up from 11% in 2020 to more than 40% in 2021. Our current mental healthcare system cannot adequately accommodate the current crisis; it is therefore important to identify opportunities for public mental health interventions. Objective: Assess whether modifiable emotional factors may offer a point of intervention for the mental health crisis. Design setting and participants: From January 13 to 15, 2022, adults living in the United States were recruited via Amazon Mechanical Turk to complete an anonymous survey. Main outcomes and measures: Linear regressions tested whether the primary outcomes during the SARS-CoV-2 pandemic (depressive and anxiety symptoms, burnout) were associated with hypothesized modifiable risk factors (loneliness and need for closure) and hypothesized modifiable protective factors (the ability to perceive emotions and connect with others emotionally; emotion-regulation efficacy; and resilience, or the ability to "bounce back" after negative events). Results: The sample included 1,323 adults (mean [SD] age 41.42 [12.52] years; 636 women [48%]), almost half of whom reported clinically significant depressive (29%) and/or anxiety (15%) symptoms. Approximately 90% of participants indicated feeling burned out at least once a year and nearly half of participants (45%) felt burned out once a week or more. In separate analyses, depressive symptoms (Model A), anxiety symptoms (Model B), and burnout (Model C) were statistically significantly associated with loneliness (ßModel A, 0.38; 95% CI, 0.33-0.43; ßModel B, 0.30; 95% CI, 0.26-0.36; ßModel C, 0.34; 95% CI, 0.28-0.41), need for closure (ßModel A, 0.09; 95% CI, 1.03-1.06; ßModel B, 0.13; 95% CI, 0.97-0.17; ßModel C, 0.11; 95% CI, 0.07-0.16), recent stressful life events (ßModel A, 0.14; 95% CI, 0.10-0.17; ßModel B, 0.14; 95% CI, 0.11-0.18; ßModel C, 0.10; 95% CI, 0.06-0.15), and resilience (ßModel A, -0.10; 95% CI, -0.15 to -0.05; ßModel B, -0.18; 95% CI, -0.23 to -0.13; ßModel C, -0.11; 95% CI, -0.17 to -0.05). In addition, depressive and anxiety symptoms were associated with emotional self-efficacy (ßModel A, -0.17; 95% CI, -0.22 to -0.12; ßModel B, -0.11; 95% CI, -0.17 to -0.06), and beliefs about the malleability of emotions (ßModel A, -0.08; 95% CI, -0.12 to -0.03; ßModel B, -0.09; 95% CI, -0.13 to -0.04). Associations between loneliness and symptoms were weaker among those with more emotional self-efficacy, more endorsement of emotion malleability beliefs, and greater resilience, in separate models. Analyses controlled for recent stressful life events, optimism, and social desirability. Conclusion and relevance: Public mental health interventions that teach resilience in response to negative events, emotional self-efficacy, and emotion-regulation efficacy may protect against the development of depressive symptoms, anxiety, and burnout, particularly in the context of a collective trauma. Emotional self-efficacy and regulation efficacy may mitigate the association between loneliness and mental health, but loneliness prevention research is also needed to address the current mental health crisis.

Participants and Study Decliners' Perspectives About the Risks of Participating in a Clinical Trial of Whole Genome Sequencing.

An increasing number of individuals are being recruited to whole genome sequencing (WGS) research. When asked hypothetically, the majority of the public express willingness to participate in this type of research, yet little is known about how many individuals will actually consent to research participation or what they perceive the risks to be. The MedSeq Project is a clinical trial exploring WGS in clinical care. We documented primary reason(s) for declining participation and reviewed audio-recorded informed consent sessions to identify participants' concerns. Of 514 individuals recruited, 173 (34%) actively declined, 205 (40%) enrolled, and the remaining 136 (26%) were ineligible, unresponsive or waitlisted. Although the majority of active decliners cited logistical barriers, 40% cited risks related to the ethical, legal, and social implications (ELSI) of WGS research. Participants similarly discussed ELSI-related concerns but felt the potential benefits of participation outweighed the risks. Findings provide insight into the perspectives of potential WGS research participants and identify potential barriers to participation.

Social and behavioral research in genomic sequencing: approaches from the Clinical Sequencing Exploratory Research Consortium Outcomes and Measures Working Group.

The routine use of genomic sequencing in clinical medicine has the potential to dramatically alter patient care and medical outcomes. To fully understand the psychosocial and behavioral impact of sequencing integration into clinical practice, it is imperative that we identify the factors that influence sequencing-related decision making and patient outcomes. In an effort to develop a collaborative and conceptually grounded approach to studying sequencing adoption, members of the National Human Genome Research Institute's Clinical Sequencing Exploratory Research Consortium formed the Outcomes and Measures Working Group. Here we highlight the priority areas of investigation and psychosocial and behavioral outcomes identified by the Working Group. We also review some of the anticipated challenges to measurement in social and behavioral research related to genomic sequencing; opportunities for instrument development; and the importance of qualitative, quantitative, and mixed-method approaches. This work represents the early, shared efforts of multiple research teams as we strive to understand individuals' experiences with genomic sequencing. The resulting body of knowledge will guide recommendations for the optimal use of sequencing in clinical practice.

The MedSeq Project: a randomized trial of integrating whole genome sequencing into clinical medicine.

BACKGROUND: Whole genome sequencing (WGS) is already being used in certain clinical and research settings, but its impact on patient well-being, health-care utilization, and clinical decision-making remains largely unstudied. It is also unknown how best to communicate sequencing results to physicians and patients to improve health. We describe the design of the MedSeq Project: the first randomized trials of WGS in clinical care. METHODS/DESIGN: This pair of randomized controlled trials compares WGS to standard of care in two clinical contexts: (a) disease-specific genomic medicine in a cardiomyopathy clinic and (b) general genomic medicine in primary care. We are recruiting 8 to 12 cardiologists, 8 to 12 primary care physicians, and approximately 200 of their patients. Patient participants in both the cardiology and primary care trials are randomly assigned to receive a family history assessment with or without WGS. Our laboratory delivers a genome report to physician participants that balances the needs to enhance understandability of genomic information and to convey its complexity. We provide an educational curriculum for physician participants and offer them a hotline to genetics professionals for guidance in interpreting and managing their patients' genome reports. Using varied data sources, including surveys, semi-structured interviews, and review of clinical data, we measure the attitudes, behaviors and outcomes of physician and patient participants at multiple time points before and after the disclosure of these results. DISCUSSION: The impact of emerging sequencing technologies on patient care is unclear. We have designed a process of interpreting WGS results and delivering them to physicians in a way that anticipates how we envision genomic medicine will evolve in the near future. That is, our WGS report provides clinically relevant information while communicating the complexity and uncertainty of WGS results to physicians and, through physicians, to their patients. This project will not only illuminate the impact of integrating genomic medicine into the clinical care of patients but also inform the design of future studies. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01736566.