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The earthquake has long-lasting various mental and behavioral effects on children and adolescents. The aim of this review was to discuss the nature and extent of psychiatric problems, management options, and the process of organizing psychological interventions for affected children. Individuals show a range of physically, emotionally, and cognitively healthy responses that can help them cope with the aftermath of a disaster. Psychiatric symptoms such as acute stress reactions, post-traumatic stress disorder, depression, anxiety disorder, increased risk of suicide, sleep disorders, substance use disorders, and psychotic disorders may develop in some children. Comorbidities and sub-clinical syndromes are also common. There are many risk factors and protective factors in the development of mental disorders. Close follow-up of children at high risk and interventions for psychosocial support may prevent the development of mental disorders. It is very important to start the intervention at the earliest period. The psychological impacts of young disaster victims can be addressed by skilled local volunteers, medical professionals, and educators in primary health care programs. With the nation's overall social and economic recovery, children can recover more quickly from traumatic experiences.Copyright © 2023, Duzce University Medical School. All rights reserved.
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Background: The COVID-19 pandemic has led to an increased workload and work pressure on nurses owing to the unpredictable changes during this challenging situation. Herein, we explored the relationship between hopelessness and job burnout in nurses working in China against the backdrop of the COVID-19 outbreak. Method: This was a cross-sectional study involving 1216 nurses in two hospitals in Anhui Province. The data was collected using an online survey. The mediation and moderation model was constructed, and the data was analyzed using SPSS PROCESS macro software. Results: Our results showed that the nurses had an average job burnout score of 1.75 ± 0.85. Further analysis revealed a negative correlation between hopelessness and career calling (r = -0.551, P < 0.01) and a positive correlation between hopelessness and job burnout (r = 0.133, P < 0.01). Additionally, a negative correlation was demonstrated between career calling and job burnout (r = -0.138, P < 0.01). Moreover, career calling strongly mediated (by 40.9%) the relationship between hopelessness and job burnout in the nurses. Finally, social isolation in the nurses was a moderating factor for the association between hopelessness and job burnout (ß = 0.028, t = 2.851, P < 0.01). Conclusion: Burnout severity in nurses increased during the COVID-19 pandemic. Career calling mediated the relationship between hopelessness and burnout, with greater burnout levels in nurses who experienced social isolation. Therefore, we suggest that job burnout in nurses can be improved by mitigating the effects of hopelessness and social isolation through psychological interventions and enhancing their sense of career calling through education to strengthen their professional identity.
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The university period, in which people realize, evaluate and develop themselves, is extremely important. In this process, job and future uncertainty, expectations and negative influences, especially in the last year, can cause anxiety in people. This situation also affects the learning process of individuals. The aim of this study is to determine the severity of the anxiety levels in terms of various variables of the senior statistics department students. The research covers the senior students of the statistics department of the Science Faculty at Ankara research universities in the 2020-2021 academic year. Based on Ankara, Gazi, Hacettepe and Middle East Technical Universities, the sample size of the sample to be selected was determined in equal shares and 93 samples were obtained, under the assumption that the senior students of the Statistics Department of each university had equal anxiety. "Spielberger State-Trait Anxiety Inventory" and "Beck Hopelessness Scale" were applied to the research group. The obtained data were analyzed with SPSS 28 statistical program. It has been observed that the anxiety and hopelessness levels of senior statistics department students are affected by the effects of COVID-19 on future plans, monthly income, weighted grade point average at the university, age, advantages outside the university, and work experience variables, and are not affected by the gender, marital status, number of siblings, graduated high school type, university studied, reason for choosing statistics department, pre-university settlement, parent education status, job priority, future job prospect, current job prospects, current working status, the idea of finding a suitable job time in accordance with the received education, the most appropriate strategy in case of the not employed within one year, self-development in the COVID-19 pandemic variables. As a result, it is considered that the senior students' anxiety and hopelessness should be reduced, in order to improve themselves better and more effectively providing psychological counseling and guidance services and by increasing training seminars in this direction in the education process, necessary to support them in order to cope with anxiety and hopelessness.
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It is well established that COVID-19 pandemic is associated with arousal of feelings of hopelessness and negativity in adolescents regarding future career development outcomes. However, the current literature has yet to clarify the roles teacher social support play in facilitating students' positive career development during the pandemic. This study investigated the effects of career-related teacher support (CRTS) on ameliorating students' feelings of hopelessness and increasing their career self-efficacy among 402 senior secondary students (Grades 10-12) in Hong Kong, China. Results from mediated moderation analyses showed that academic ability was only weakly related to career self-efficacy. Hopelessness was not a significant moderator concerning the link between academic ability and career self-efficacy when CRTS functioned as the mediator. [ FROM AUTHOR] Copyright of British Journal of Guidance & Counselling is the property of Routledge and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)
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Objective: The study aims to assess the impact of COVID-19 on healthcare workers' work-related stress during the first wave of the pandemic in Italy. The main objective is to investigate the existence of a positive correlation between hopelessness and burnout, assuming that burnout may be a risk factor for the development of hopelessness, and to analyze the role that trait Emotional Intelligence (TEI) and changes in workload could have in this relationship. Furthermore, evaluate any significant differences in burnout and hopelessness levels in the function of some demographic variables, such as gender, professional profiles, and different working zones of Italy, to better understand how the diverse diffusion of pandemic had affected Italian healthcare workers. Methods: An online survey was used to collect data between April and June, 2020, with 562 responses among nurses (52.1%) and physicians (47.9%). Demographics and changes in workload and work conditions were collected through an ad hoc questionnaire. The Trait Emotional Intelligence Questionnaire-Short Form (TEIQue-SF), The Beck Hopelessness Scale (BHS), and the Link Burnout Questionnaire (LBQ) were used to assess Trait Emotional Intelligence (TEI), hopelessness, and burnout, respectively. Results: Correlation analysis showed a significant positive relationship between hopelessness and each burnout dimension. TEI showed negative correlations both with burnout dimensions and hopelessness. Significant differences in burnout and hopelessness levels emerged as a function of some demographic variables such as gender, professional profiles (nurses or physicians), and different working zone of Italy (northern or southern). Results showed that TEI partially mediated the relationship between hopelessness and every burnout dimension, while the interaction of changes in workload was non-significant. Discussion: The mediating role of TEI in the burnout-hopelessness relationship partly explains the protective role that individual factors had on healthcare workers' mental health. Our findings support the need to integrate considerations on both psychological risk and protective factors into COVID-19 care, including the monitoring of psychological symptoms and social needs, especially among healthcare workers.
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Background and Aims: The COVID-19 pandemic has caused new conditions such as nationwide quarantine, a dramatic decrease in-person interaction and an increase in death anxiety for governments and people. The pandemic of an unpredictable disease with no definite treatment can pose physical and psychological risks to individuals. The present study aimed to investigate the state of anxiety, coping styles, and hopelessness of people in the lockdown period and reopening in Iran. Methods: In this national population-based cross-sectional study, a total of 1191 people who had access to social networks from all over Iran completed the anxiety, hopelessness, and coping style questionnaires online using the snowball sampling method. Analysis was conducted using Stata software version 12 (Stat Corp). The significance level was set at 0.05. Results: The results of the study suggested that women experienced higher levels of anxiety than men, and, in stressful situations, women were more likely to use emotion-focused coping styles, while men frequently used problem-focused coping styles. The majority of participants reported moderate levels of anxiety and low levels of hopelessness (64.04%). The results of multiple linear regression show any level of anxiety mild (ß = 0.59, 95% confidence interval [CI]: 0.32-0.85), moderate (ß = 0.72, 95% CI: 1.36-1.08), and severe (ß = 2, 95% CI: 1.36-2.56) relative to the none anxiety significantly increase the hopelessness, Furthermore, showing a negative significant adjusted association with the problem-focused coping style (ß = -0.06, 95% CI: -0.07 to -0.04), and a significant positive association with the emotion-focused coping style (ß = 0.04, 95% CI: 0.02-0.06). Conclusion: Our findings could be used to prevent psychological damage in societies and suggested addressing problem-focused coping style, especially during a crisis, and providing people with preprepared mental health protocols at this pandemic.
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The aim of this study was to determine the relationship between depression, hopelessness and life satisfaction with death anxiety and the determinants of death anxiety in individuals who have had COVID-19. This descriptive and correlational study was conducted with 402 adult individuals. Personal Information Form, Thorson-Powell Death Anxiety Scale, Beck Depression Scale, Beck Hopelessness Scale and Satisfaction with Life Scale were used to collect the data. In the study, a positive relationship was found between death anxiety and depression and hopelessness, and a negative relationship was found between death anxiety and life satisfaction (p < .001). As a result, being female, having undergraduate or graduate education, having high levels of depression and hopelessness and low life satisfaction were found to be determinants of death anxiety.
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Introduction: Nursing students are a vulnerable population during the COVID-19 pandemic because they experience a higher level of stress and mental health problems than the non-healthcare student population, putting them at a higher risk for suicidal behaviour.Aim: To explore suicidality among nursing students and assess the association between independent variables and suicidality. Methods: This cross-sectional study involved 670 nursing students from 5 Indonesian universities who were recruited using consecutive sampling. Self-administered validated instruments consisted of 8 sections: sociodemographic questionnaire, RSES to assess self-esteem, BHS to assess hopelessness, UCLA-3 to assess loneliness, GSES to assess self-efficacy, PHQ-9 to assess depression, CD-RISC-10 to assess resilience, and SBQ-R to assess suicidality. Binary logistic regression was employed to identify significant predictors of suicidality.Results: Suicidality prevalence among nursing students was 22.8%. The following factors were significantly associated with suicidality (p < 0.05): low resilience (AOR = 2.044;95%CI: 1.309-3.192), loneliness (AOR = 1.609;95%CI: 1.040-2.492), hopelessness (AOR = 4.448;95%CI: 2.356-8.398), and depression (AOR = 9.413;95%CI: 5.795-15.288).Conclusions: These findings provide evidence that resilience, loneliness, hopelessness, and depression are risk factors for suicidality among nursing students. This outcome can be used as a basis to develop appropriate suicide prevention strategies.
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It is well known that the COVID-19 pandemic caused significant treatment delays for dermatology patients, and recent studies demonstrate poor outcomes for patients with cutaneous T-cell lymphoma (CTCL) during this time. However, not much is known about patient reported delays in management of this condition following the pandemic. This study sought to evaluate patient-reported illness anxiety and delays in management of CTCL. Fifty-two CTCL patients were recruited from clinic from October 2020 to October 2021. Patients were asked to complete a 22-question survey adapted from the United States Census Household Pulse Survey. Control data was extrapolated from published national data from the Household Pulse Survey. Of 52 patients surveyed, 28 were male (59.6%). 25 identified as white (54.3%), 18 as Black (39.1%), 8 as Asian (15.3%) and 1 as Native American (2.2%). Average age was 57 years, age range 24-89 years. Results demonstrate that 32.6% (n=15) of respondents had a household member experience loss of employment since March 2020 compared to 39.6% of the US population. 46.8% of respondents vs. 32.3% US population noted some level of difficulty in paying for household expenses including medical care. Only 4.3% of respondents noted that they delayed receiving medical care due to the coronavirus pandemic. When compared to the US population (59.8%), a lower proportion of respondents (48.9%) noted symptoms of nervousness or anxiety over the past week. 27.7% of respondents vs. 46.1% of US population reported feelings of hopelessness or depression over the past week. These results demonstrate a low number of patients reporting care delays, possible due to the interval when data was collected, several months after COVID-19 onset. It is also possible that telehealth contributed to lessening delays in care. Overall, the results of this study reinforce the significant physical, financial, and emotional impact of CTCL on the daily lives of patients, and the heightened impact of COVID-19 on this population.Copyright © 2023
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BACKGROUND: Suicide-related behaviors increasingly contribute to behavioral health crises in the United States (U.S.) and worldwide. The problem was worsened during the COVID-19 pandemic, especially for youth and young adults. Existing research suggests suicide-related behaviors are a consequence of bullying, while hopelessness is a more distal consequence. This study examines the association of in-school and electronic bullying with suicide-related behavior and feelings of despair among adolescents, adjusted for sociodemographic characteristics, abuse experience, risk-taking behaviors, and physical appearance/lifestyles. METHOD: Using Chi-square, logistic regression, and multinomial logistic regression, we analyzed the US 2019 Youth Risk Behavior Surveillance System (YRBSS) national component. The YRBSS includes federal, state, territorial, and freely associated state, tribal government, and local school-based surveys of representative sample middle and high school students in the US. The 2019 YRBSS participants comprised 13,605 students aged 12 to 18 years and roughly equal proportions of males and females (50.63% and 49.37%, respectively). RESULTS: We observed a significant association (p < 0.05) between being bullied and depressive symptoms, and the association was more vital for youth bullied at school and electronically. Being bullied either at school or electronically was associated with suicidality, with a stronger association for youth who experienced being bullied in both settings. CONCLUSION: Our findings shed light on assessing early signs of depression to prevent the formation of suicidality among bullied youth.
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OBJECTIVE: To measure symptoms of anxiety, depression and hopelessness in a sample of young Pacific adults living in Auckland, New Zealand during the 2020/2021 COVID-19 pandemic and identify protective factors. METHODS: Participants were 267 Pacific adults (58% female) who completed a survey online. Analyses included descriptive statistics, correlations, linear regression and symptom network analysis. RESULTS: Around 25% of the sample scored in the range for moderate to severe anxiety and 10% for moderate to severe depression on standard measures. Almost 40% indicated that they found the first lockdown very stressful and 55% noted that some members of their family found it stressful. Only 16% worried about COVID-19 and their future quite a bit or constantly, while another 25% worried sometimes. Self-compassion and Pacific Identity had moderate, negative correlations, and Worry about COVID-19 had weak positive correlations, with anxiety, depression, hopelessness and perceived stress. CONCLUSION: These results suggest that, while the prevalence of depression and anxiety are quite high among this population, fostering ethnic identity and self-compassion in Pacific children and adolescents might protect against developing depression and anxiety.
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A correlational study (n = 180 adults) in the United States tested the hypothesis that self-directed humor styles predict emotional responses to COVID-19, specifically stress and hopelessness, and in turn predict engagement in protective behaviors. Results from a sequential mediation analysis supported our hypotheses. First, to the extent that people have a self-enhancing humor style they perceived less stress and hopelessness associated with COVID-19 and as a result reported engaging in more protective behaviors. Second, people higher in self-defeating humor style showed the opposite pattern;they perceived more stress and hopelessness due to COVID-19 and thus reported engaging in less protective behaviors. Implications for theory and application are discussed. (PsycInfo Database Record (c) 2022 APA, all rights reserved)
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Aim: Fear of childbirth is an emotional stress that affects the mental health and well-being of mothers during pregnancy. The aim of the present study was to compare the prenatal attachment, childbirth fear and hopelessness levels of pregnant women who had and did not have COVID-19 infection during pregnancy. Material(s) and Method(s): This prospective questionnaire study was conducted with participants between the ages of 18 and 40 who had 20 or more gestational weeks. Two groups were formed as follows: Group 1: Participants who had COVID-19 infection, and Group 2: Participants who did not have COVID-19 infection during pregnancy. Patients in both groups were given questionnaires using Wijma Delivery Expectancy/Experience Questionnaire, Prenatal Attachment Inventory and Beck Hopelessness Scale, and the results were recorded. Result(s): Childbirth fear and Beck Hopelessness Scale scores were higher in Group 1 than in Group 2 (p < 0.001 and p = 0.023, respectively). The Prenatal Attachment Inventory scale score of Group 2 was higher than that of Group 1 (p = 0.001). A negative correlation was observed between childbirth fear and prenatal attachment scores (p = 0.012, r=-0.250). There was a negative correlation between the Beck Hopelessness Scale score and Prenatal Attachment Inventory scores (p < 0.001, r=-0.416). Discussion(s): Covid-19 infection during pregnancy increased the childbirth fear and hopelessness levels in pregnant women while reducing the prenatal attachment level. Pregnant women should be informed about prevention methods against COVID-19 infection and necessary measures should be taken.Copyright © 2022, Derman Medical Publishing. All rights reserved.
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Alcohol use and depression are common among college students and often co-occur. When comorbid, the consequences of alcohol use and depression in college students are more severe than those associated with either difficulty on its own. Hopelessness and the COVID-19 pandemic contribute to both depression and alcohol use in college students. However, there is limited research on whether greater hopelessness or the COVID-19 pandemic strengthen the relationship between alcohol use and depressive symptom severity. The purpose of this study was to determine whether hopelessness or participation during the COVID-19 pandemic were moderators of the relationship between alcohol use and depressive symptom severity in this sample. Survey data was collected from 378 emerging adult college students at a diverse public university. The constructs of alcohol use, depressive symptom severity, and hopelessness were measured using self-report measures. The date of participation was used to gauge participation prior to or during the COVID-19 pandemic. Moderation analysis was conducted using the PROCESS macro in SPSS. Findings showed that neither hopelessness nor participating during the COVID-19 pandemic were moderators of the relationship between alcohol use and depressive symptom severity in college students. Alcohol use and hopelessness were both associated with depressive symptom severity in emerging adult college students. These findings extend prior research on alcohol use and depression in college students and indicate a further need to examine potential factors that influence the relationship between the two. (PsycInfo Database Record (c) 2022 APA, all rights reserved)
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Background: Confirmed and suspected patients with SARS-CoV-2 may fear contagion to others and the severe consequences of the disease. Therefore, they may feel loneliness, denial, anxiety, depression, insomnia, and hopelessness, reducing treatment adherence. Objective(s): This study aimed to discuss the psychological challenges of survivors' experiences in SARS-CoV-2 infection. Method(s): This descriptive phenomenological study explored survivors' experiences of COVID-19 infection. Validated websites' stories and notes were used to collect data. The stories were transcribed and analyzed by Colaizzi's phenomenological analysis method. The authors screened the transcribed texts, extracted and summarized meaningful statements, and reported the themes indepen-dently. In addition, six criteria of authority, accuracy, objectivity, currency, coverage, and appearance were considered for evaluating web page quality. The data were analyzed using MAXQDA 10 software. Result(s): A total of 45 patients' stories with COVID-19 were analyzed. Four general themes and 11 sub-themes were extracted via reading stories and extracting themes, including stigma (the sub-themes of embarrassment, defame, and Hopelessness), horror (sub-themes of denial, not professional experience, and toward death), different lifestyles (the sub-themes of change, unfriended, and sleeplessness), and freedom (two sub-themes of calmness and Rescue). Conclusion(s): Based on the studies, the participants reported high rates of symptoms of fear, change, insomnia, and horror. Sup-porting COVID-19 patients in these critical conditions is one of the essential components of acute care measures. Specific interventions to promote mental health in exposed patients should be applied immediately and require special attention.Copyright © 2023, Journal of Kermanshah University of Medical Sciences.
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Emerging adults with high levels of inhibited personality traits may be at-risk for drinking to cope during the COVID-19 pandemic. The current research explored mediational pathways between two inhibited personality traits (anxiety sensitivity (AS) and hopelessness (HOP)), internalizing symptoms (anxiety, depression, and COVID-19 distress), and coping drinking motives (drinking to cope with anxiety and drinking to cope with depression) during the pandemic. Cross-sectional data were collected from 879 undergraduate drinkers (79% female, 83% White, 18-25 years old) at five Canadian universities from January-April 2021. Participants self-reported on their personality, anxiety (GAD-7), depressive symptoms (PHQ-9), COVID-19 distress, and coping drinking motives. Mediational path analyses provided evidence of both specific and non-specific pathways between personality and coping motives via internalizing symptoms. Depressive symptoms partially mediated the link between HOP and drinking to cope with depression motives. While anxiety symptoms did not significantly mediate links between AS and coping with anxiety motives in the full model, evidence of mediation was found in a post-hoc sensitivity analysis. COVID-19 distress served as a non-specific mediator. AS and HOP are critical transdiagnostic risk factors that increase vulnerability for internalizing psychopathology and, in turn, risky drinking motives, in the context of the COVID-19 pandemic.
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Alcohol Drinking , COVID-19 , Humans , Adult , Female , Adolescent , Young Adult , Male , Pandemics , Cross-Sectional Studies , Canada , Motivation , Personality , Adaptation, PsychologicalABSTRACT
INTRODUCTION: Emergence of the Delta variant in 2021 changed the pandemic landscape and led to healthcare surges across the US, despite availability of COVID-19 vaccine. Anecdotal information indicated that the infection prevention and control (IPC) field was changing, but formal assessment was needed. METHODS: Focus groups (6) were conducted with APIC members in November and December, 2021 to elicit infection preventionists' (IP) opinions changes to the IPC field due to the pandemic. Focus groups were audio recorded via Zoom and transcribed. Content analysis was used to identify major themes. RESULTS: Ninety IPs participated. IPs described multiple changes to the IPC field during the pandemic, including being more involved in policy development, the challenge of transitioning back to routine IPC while still responding to COVID-19, increased need for IPs across practice settings, difficulties in recruiting and retaining IPs, presenteeism in healthcare, and extensive burnout. Participants suggested approaches to improve IPs' wellbeing. CONCLUSIONS: The ongoing pandemic has brought significant changes to the IPC field, including a shortage of IPs just as the field is expanding rapidly. The continued overwhelming workload and stress due to the pandemic has resulted in burnout among IPs and the need for initiatives to improve their wellbeing.
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COVID-19 has impacted negatively on the lives and academic activities of university students. This has contributed to increasing levels of psychological distress among this population group. Intrinsic and contextual factors can mediate the psychological impact of the pandemic. The study focuses on sense of coherence and ego-resilience as potential protective factors on indices of psychological distress and life satisfaction. Participants were undergraduate students (N = 337) at a South African university who completed six self-report questionnaires, namely, the Beck Hopelessness Scale, the University of California Los Angeles Loneliness Scale, the Center for Epidemiological Studies Depression Scale, the Sense of Coherence Scale, the Ego-Resilience Scale, and the Satisfaction with Life Scale. To examine the direct and mediating effects of sense of coherence and ego-resilience on psychological distress, structural equation modeling was used. Compared to previous research, greater psychological distress was found in the current sample. Moreover, while the hopelessness-life satisfaction relationship was only partially mediated by protective factors, the depression-life satisfaction relationship was fully mediated by sense of coherence and ego-resilience. The direct association between ego-resilience as well as sense of coherence and life satisfaction was significant, suggesting that these factors have a health-sustaining role.
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BACKGROUND: The death of a loved one was a challenge many people faced during the COVID-19 pandemic within the context of extraordinary circumstances and great uncertainty. Grief is an unavoidable part of life, and for most people, feelings of grief decrease naturally over time. However, for some people, grieving can become a particularly painful process with clinical symptoms that may require professional help to resolve. To provide psychological support to people who had lost a loved one during the COVID-19 pandemic, an unguided web-based psychological intervention was developed. OBJECTIVE: The main objective of this study was to evaluate the efficacy of the web-based treatment, Grief COVID (Duelo COVID in Spanish; ITLAB), in reducing clinical symptoms of complicated grief, depression, posttraumatic stress, hopelessness, anxiety, and suicidal risk in adults. The secondary aim was to validate the usability of the self-applied intervention system. METHODS: We used a randomized controlled trial with an intervention group (IG) and a waitlist control group (CG). The groups were assessed 3 times (before beginning the intervention, upon completing the intervention, and 3 months after the intervention). The intervention was delivered on the web in an asynchronous format through the Duelo COVID web page. Participants created an account that could be used on their computers, smartphones, or tablets. The evaluation process was automated as part of the intervention. RESULTS: A total of 114 participants were randomly assigned to the IG or CG and met criteria for inclusion in the study (n=45, 39.5% completed the intervention and n=69, 60.5% completed the waitlist period). Most participants (103/114, 90.4%) were women. The results indicated that the treatment significantly reduced baseline clinical symptoms in the IG for all variables (P<.001 to P=.006), with larger effect sizes for depression, hopelessness, grief, anxiety, and risk of suicide (all effect sizes ≥0.5). The follow-up evaluation showed that symptom reduction was maintained at 3 months after the intervention. The results from the CG showed that participants experienced significantly decreased levels of hopelessness after completing the time on the waitlist (P<.001), but their suicidal risk scores increased. Regarding the usability of the self-applied intervention system, the results indicated a high level of satisfaction with the Grief COVID. CONCLUSIONS: The self-applied web-based intervention Grief COVID was effective in reducing symptoms of anxiety, depression, hopelessness, risk of suicide risk, posttraumatic stress disorder, and complicated grief disorder. Grief COVID was evaluated by the participants, who reported that the system was easy to use. These results affirm the importance of developing additional web-based psychological tools to help reduce clinical symptoms in people experiencing grief because of the loss of a loved one during a pandemic. TRIAL REGISTRATION: ClinicalTrials.gov NCT04638842; https://clinicaltrials.gov/ct2/show/NCT04638842.