Recruiting for a randomized clinical trial for late-life depression during COVID-19: outcomes of provider referrals vs. Facebook self-referrals

Objective To evaluate the effectiveness of online recruitment for a clinical trial of pharmacotherapy for late-life depression during COVID-19. Methods We calculated the yield, defined as recruitment leading to randomization (enrollment), from provider referrals versus Facebook self-referrals;compared characteristics and drop-out rates of participants from each source;and analyzed correlations between stringency of public health restrictions and referrals from each source over time. Results Provider referrals had a significantly higher yield (10 of 33 referrals;30.3%) versus Facebook self-referrals (14 of 323;4.3%) (p<0.00001). Participants self-referred from Facebook had significantly more education;otherwise, both groups had similar characteristics and drop-out rates. While public health stringency was negatively correlated with provider referrals (ρ=–0.32) and positively correlated with Facebook self-referrals (ρ=0.39), neither association reached statistical significance. Conclusions Online recruitment may improve access to clinical research for older depressed adults. Future studies should evaluate cost-effectiveness and potential barriers such as computer literacy.

Recruiting for a Randomized Clinical Trial for Late-Life Depression During COVID-19: Outcomes of Provider Referrals Versus Facebook Self-Referrals.

OBJECTIVE: To evaluate the effectiveness of online recruitment for a clinical trial of pharmacotherapy for late-life depression during COVID-19. METHODS: The authors calculated the yield, defined as recruitment leading to randomization (enrollment), from provider referrals versus Facebook self-referrals; compared characteristics and drop-out rates of participants from each source; and analyzed correlations between stringency of public health restrictions and referrals from each source over time. RESULTS: Provider referrals had a significantly higher yield (10 of 33 referrals; 30.3%) versus Facebook self-referrals (14 of 323; 4.3%) (p <0.00001). Participants self-referred from Facebook had significantly more education; otherwise, both groups had similar characteristics and drop-out rates. While public health stringency was negatively correlated with provider referrals (ρ = -0.32) and positively correlated with Facebook self-referrals (ρ = 0.39), neither association reached statistical significance. CONCLUSION: Online recruitment may improve access to clinical research for older depressed adults. Future studies should evaluate cost-effectiveness and potential barriers such as computer literacy.

Brief App-Based Cognitive Behavioral Therapy for Anxiety Symptoms in Psychiatric Inpatients: Feasibility Randomized Controlled Trial.

BACKGROUND: Psychiatric inpatients often have limited access to psychotherapeutic education or skills for managing anxiety, a common transdiagnostic concern in severe and acute mental illness. COVID-19-related restrictions further limited access to therapy groups on inpatient psychiatric units. App-based interventions may improve access, but evidence supporting the feasibility of their use, acceptability, and effectiveness in psychiatric inpatient settings is limited. MindShift CBT is a free app based on cognitive behavioral therapy principles with evidence for alleviating anxiety symptoms in the outpatient setting. OBJECTIVE: We aimed to recruit 24 participants from an acute general psychiatric inpatient ward to a 1-month randomized control study assessing the feasibility and acceptability of providing patients with severe and acute mental illness access to the MindShift CBT app for help with managing anxiety symptoms. METHODS: Recruitment, data collection, analysis, and interpretation were completed collaboratively by clinician and peer researchers. Inpatients were randomized to two conditions: treatment as usual (TAU) versus TAU plus use of the MindShift CBT app over 6 days. We collected demographic and quantitative data on acceptability and usability of the intervention. Symptoms of depression, anxiety, and psychological distress were measured in pre- and poststudy surveys for preliminary signals of efficacy. We conducted individual semistructured interviews with participants in the MindShift CBT app group at the end of their trial period, which were interpreted using a standardized protocol for thematic analysis. RESULTS: Over 4 weeks, 33 inpatients were referred to the study, 24 consented to participate, 20 were randomized, and 11 completed the study. Of the 9 randomized participants who did not complete the study, 7 were withdrawn because they were discharged or transferred prior to study completion, with a similar distribution among both conditions. Among the enrolled patients, 65% (13/20) were admitted for a psychotic disorder and no patient was admitted primarily for an anxiety disorder. The average length of stay was 20 days (SD 4.4; range 3-21) and 35% (7/20) of patients were involuntarily admitted to hospital. Small sample sizes limited accurate interpretation of the efficacy data. Themes emerging from qualitative interviews included acceptability and usability of the app, and patient agency associated with voluntary participation in research while admitted to hospital. CONCLUSIONS: Our study benefitted from collaboration between peer and clinician researchers. Due to rapid patient turnover in the acute inpatient setting, additional flexibility in recruitment and enrollment is needed to determine the efficacy of using app-based psychotherapy on an acute psychiatric ward. Despite the limited sample size, our study suggests that similar interventions may be feasible and acceptable for acutely unwell inpatients. Further study is needed to compare the efficacy of psychotherapeutic apps with existing standards of care in this setting. TRIAL REGISTRATION: ClinicalTrials.gov NCT04841603; https://clinicaltrials.gov/ct2/show/NCT04841603.

PAS-MCI: Design and Rationale for a Randomized Controlled Trial to Enhance Prefrontal Cortical Plasticity and Working Memory in Individuals with Amnestic Mild Cognitive Impairment

Introduction Amnestic Mild Cognitive Impairment (aMCI) is a prodromal stage to Alzheimer's disease dementia (AD). Improving prefrontal cortical function in individuals with MCI could prevent progression from aMCI to AD. A key mechanism that has been linked to memory formation and thus may underlie this progression is cortical plasticity. Paired Associative Stimulation (PAS) is an intervention that uses transcranial magnetic stimulation (TMS) to enhance cortical plasticity. When delivered to the prefrontal cortex in individuals with AD, it has shown promise to improve prefrontal cortical plasticity and working memory. PAS-MCI is a randomized controlled trial (RCT) that aims to assess: (1) dorsolateral prefrontal cortex (DLPFC) plasticity in individuals with aMCI and compare it to cognitively unimpaired control participants, (2) the efficacy of PAS delivered for 10 days bilaterally to the DLPFC of individuals with aMCI in enhancing their DLPFC plasticity, working memory, and executive function, and (3) whether changes in DLPFC plasticity mediate changes in working memory and executive function. Methods 100 aMCI and 50 cognitively unimpaired (CU) control participants will be assessed clinically and cognitively, and then undergo a baseline PAS combined with electroencephalography (PAS-EEG) to characterize left DLPFC plasticity. The aMCI participants are randomized (1:1) to receive 10 daily sessions of either active or sham PAS delivered to the left and right DLPFC. On Day 0, 7, and 28 following the 10-day PAS course, participants undergo repeat cognitive testing and PAS-EEG to assess changes in working memory, executive function, and left DLPFC plasticity. Results Recruitment started on October 12, 2020 and as of October 16, 2021, we have already consented 9 aMCI and 7 CU participants. Of the 16 participants, 4 MCI and 4 CU participants were enrolled and 3 MCI and 4 CU completed the study (1 MCI participant is still active). Among the 5 participants who did not enroll, 3 were excluded because of: a contraindication for TMS (n = 1), having dementia and not MCI (n = 1), and having non-amnestic MCI (n = 1);1 withdrew before enrolment due to fatigue;and 1 is still undergoing eligibility assessments. Among the 3 CU participants who did not enroll, 2 were excluded because of low cognitive scores and 1 is still undergoing eligibility assessments. Conclusions Despite the COVID-19 pandemic, we were able to initiate recruitment over the past year. If successful, this RCT will establish the short-term efficacy of PAS, a new TMS approach to enhance prefrontal cortical function in individuals with aMCI. A follow-up longer-term trial will be then needed to assess whether PAS could prevent cognitive decline and progression to AD. This research was funded by Canadian Institutes of Health Research (CIHR) Project Grant # 201809 (PI: Rajji)

The Effect of Repetitive Transcranial Magnetic Stimulation on Suicidal Ideation in Treatment-Resistant Depression: A Meta-Analysis.

Objective: To quantitatively synthesize the literature on the effects of repetitive transcranial magnetic stimulation (rTMS) on suicidal ideation (SI) in patients with treatment-resistant depression.Data Sources: A literature search was conducted using PubMed, SCOPUS, Ovid, MEDLINE, Embase, and Web of Science from inception to January 11, 2021, for the keywords repetitive transcranial magnetic stimulation, suicidal ideation, suicidality, treatment-resistant depression, refractory depression, transcranial magnetic stimulation, and brain stimulation.Study Selection: A total of 16 publications were eligible for inclusion. Studies were included that investigated the effects of rTMS in adolescents and/or adults 16 years or older diagnosed with unipolar or bipolar depression with suicidal ideation data before and after rTMS intervention.Data Extraction: Data were extracted and managed using Covidence. Extracted data included authors, publication year, country of origin, study design, patient demographics, primary diagnosis, comorbidities, mean age, outcome assessment instruments, detailed stimulation parameters, sham control procedures, and any serious adverse events related to SI.Results: A quantitative analysis of effect size using Hedges g was calculated for both randomized controlled trials and all other uncontrolled trials. We found a decrease in SI scores in randomized controlled trials (g = 0.158, 95% confidence interval [CI] = -0.078 to 0.393, P = .191), although the effect was not significant. There was a significant decrease in suicidal ideation scores for uncontrolled trials (g = 0.692, 95% CI = 0.463 to 0.922, P < .001).Conclusions: Our findings suggest that rTMS may be an effective treatment for SI in individuals with treatment-resistant depression, although further investigation is warranted.

From challenge to opportunity: COVID-19 and the evolution of virtual mental health care.

The transition to virtual care (telehealth) during the COVID-19 pandemic has led to both challenges and opportunities in delivering effective mental health care that meets the needs of patients and families. The negative mental and physical health effects of isolation and loneliness associated with the pandemic present a challenge for community mental and behavioral health care. However, the advantages that virtual care provides for the delivery of mental health services, particularly the potential for improved access, also benefit both providers and patients. Ongoing barriers to wider adoption and utilization of virtual mental health care need to be addressed. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Impact of COVID-19 on motor vehicle injuries and fatalities in older adults in Ontario, Canada.

BACKGROUND: Older adults constitute the group most vulnerable to COVID-19 mortality. As a result, in North America and elsewhere, older adults have been strongly advised to shelter in place. Older adults also represent the fastest growing segment of licensed drivers. OBJECTIVE: We examined the change in injuries and fatalities sustained by younger and older drivers and pedestrians during the first month of the COVID-19 pandemic. We hypothesized that adults ages 80 years and over would have a proportionally larger reduction than the other drivers and pedestrians. METHODS: Using a cohort design, we compared the proportion of drivers and pedestrians involved in injuries and fatalities attributable to individuals aged 80 years and over, as recorded in the Ministry of Transportation of Ontario (Canada) database, between the 30 days prior to shelter-in-place related to the COVID-19 pandemic and the subsequent 30 days. By way of comparison, we conducted a similar comparison for younger age cohorts (16-24 years, 25-34 years, 35-54 years, 55-64 years, and 65-79 years). RESULTS: Drivers aged 80 years and over represented 21 per 1000 injuries and fatalities in the 30 days prior to March 17, 2020 (95 % CI: 15-29), and 8 per 1000 injuries and fatalities in the 30 days beginning on that date (95 % CI: 2-20), a 64.7 % reduction (exp (ß) post 0.353, 95 % CI 0.105-0.892). Drivers in the 35-54 year age range underwent a significant but smaller reduction of 22.9 %; no significant changes were seen for drivers in other age groups, or for pedestrians of any age. CONCLUSIONS AND RELEVANCE: The physical distancing measures that aimed to reduce the spread of COVID-19 resulted in a marked reduction in driver injuries and fatalities in the oldest old, illustrating the impact of physical distancing recommendations in this population. The excess mortality burden faced by the oldest adults during the COVID-19 pandemic, by direct exposure to the virus, may be indirectly mitigated by the reduction in road-related deaths in this cohort.

The Impact of COVID-19 on Psychiatric Emergency and Inpatient Services in the First Month of the Pandemic in a Large Urban Mental Health Hospital in Ontario, Canada.

The World Health Organization characterized COVID-19 (coronavirus disease 2019) as a pandemic on March 11, 2020 (WHO). Within a couple of days, all Canadian provinces announced the implementation of social distancing measures. We evaluated the immediate effect of COVID-19 on psychiatric emergency and inpatient services in Canada's largest psychiatric hospital in the first month of the pandemic. We extracted data from the electronic medical records of the Center for Addiction and Mental Health in Toronto, Canada. We compared emergency department visits, inpatient occupancy rates, and length of stay in March 2019 and March 2020, and during the first and second half of March 2020. There was a decrease in the number of emergency department visits and inpatient occupancy rates in March 2020 compared to March 2019. There was also a significant decrease in the number of emergency department visits and inpatient occupancy rates in the second half of March 2020 compared to the first half. Our findings suggest that the pandemic was followed by a rapid decrease in the usage of psychiatric emergency and inpatient services in a large mental health hospital. Future studies will need to assess whether this decrease will be followed by a return to baseline or an increase in need for these services.

COVID-19: Implications for bipolar disorder clinical care and research.

The COVID-19 pandemic has posed significant challenges to health care globally, and individuals with bipolar disorder are likely disproportionally affected. Based on review of literature and collective clinical experience, we discuss that without special intervention, individuals with bipolar disorder will experience poorer physical and mental health outcomes due to interplay of patient, provider and societal factors. Some risk factors associated with bipolar disorder, including irregular social rhythms, risk-taking behaviours, substantial medical comorbidities, and prevalent substance use, may be compounded by lockdowns, social isolation and decrease in preventive and maintenance care. We further discuss implications for clinical research of bipolar disorders during the pandemic. Finally, we propose mitigation strategies on working with individuals with bipolar disorder in a clinical and research context, focusing on digital medicine strategies to improve quality of and accessibility to service.

Effectively Caring for Individuals With Behavioral and Psychological Symptoms of Dementia During the COVID-19 Pandemic.

The COVID-19 pandemic has significantly affected the elderly and particularly individuals with Alzheimer's disease and related disorders (ADRD). Behavioral and psychological symptoms of dementia (BPSD) are heterogeneous and common in individuals with ADRD and are associated with more severe illness. However, unlike the cognitive symptoms of ADRD that are usually progressive, BPSD may be treatable. Individuals with BPSD are facing unique challenges during the pandemic due to the inherent nature of the illness and the biological and psychosocial impacts of COVID-19. These challenges include a higher risk of severe COVID-19 infection in individuals with BPSD due to their frailty and medical vulnerability, difficulty participating in screening or testing, and adhering to infection control measures such as physical distancing. Further, biological effects of COVID-19 on the brain and its psychosocial impact such as isolation and disruption in mental health care are likely to worsen BPSD. In this paper, we discuss these challenges and strategies to manage the impact of COVID-19 and to effectively care for individuals with BPSD in community, long-term care, or hospital settings during the pandemic. Despite the ongoing uncertainty associated with this pandemic, we can reduce its impact on individuals with BPSD with a proactive approach.

COVID-19 and persons with substance use disorders: Inequities and mitigation strategies.

The COVID-19 pandemic disproportionately disrupts the daily lives of marginalized populations. Persons with substance use disorders are a particularly vulnerable population because of their unique social and health care needs. They face significant harm from both the pandemic itself and its social and economic consequences, including marginalization in health care and social systems. Hence, we discuss: (1) why persons with substance use disorders are at increased risk for infection with COVID-19 and a severe illness course; (2) anticipated adverse consequences of COVID-19 in persons with substance use disorders; (3) challenges to health care delivery and substance use treatment programs during and after the COVID-19 pandemic; and (4) the potential impact on clinical research in substance use disorders. We offer recommendations for clinical, public health, and social policies to mitigate these challenges and to prevent negative outcomes.

Coping, fostering resilience, and driving care innovation for autistic people and their families during the COVID-19 pandemic and beyond.

The new coronavirus disease (COVID-19) pandemic is changing how society operates. Environmental changes, disrupted routines, and reduced access to services and social networks will have a unique impact on autistic individuals and their families and will contribute to significant deterioration in some. Access to support is crucial to address vulnerability factors, guide adjustments in home environments, and apply mitigation strategies to improve coping. The current crisis highlights that our regular care systems are not sufficient to meet the needs of the autism communities. In many parts of the world, people have shifted to online school and increased use of remote delivery of healthcare and autism supports. Access to these services needs to be increased to mitigate the negative impact of COVID-19 and future epidemics/pandemics. The rapid expansion in the use of telehealth platforms can have a positive impact on both care and research. It can help to address key priorities for the autism communities including long waitlists for assessment and care, access to services in remote locations, and restricted hours of service. However, system-level changes are urgently needed to ensure equitable access and flexible care models, especially for families and individuals who are socioeconomically disadvantaged. COVID-19 mandates the use of technology to support a broader range of care options and better meet the diverse needs of autistic people and their families. It behooves us to use this crisis as an opportunity to foster resilience not only for a given individual or their family, but also the system: to drive enduring and autism-friendly changes in healthcare, social systems, and the broader socio-ecological contexts.

Experiences of American Older Adults with Pre-existing Depression During the Beginnings of the COVID-19 Pandemic: A Multicity, Mixed-Methods Study.

OBJECTIVE: To determine the effect of the COVID-19 pandemic on the mental health of older adults with pre-existing major depressive disorder (MDD). PARTICIPANTS: Participants were 73 community-living older adults with pre-existing MDD (mean age 69 [SD 6]) in Los Angeles, New York, Pittsburgh, and St Louis. DESIGN AND MEASUREMENTS: During the first 2 months of the pandemic, the authors interviewed participants with a semistructured qualitative interview evaluating access to care, mental health, quality of life, and coping. The authors also assessed depression, anxiety, and suicidality with validated scales and compared scores before and during the pandemic. RESULTS: Five themes from the interviews highlight the experience of older adults with MDD: 1) They are more concerned about the risk of contracting the virus than the risks of isolation. 2) They exhibit resilience to the stress and isolation of physical distancing. 3) Most are not isolated socially, with virtual contact with friends and family. 4) Their quality of life is lower, and they worry their mental health will suffer with continued physical distancing. 5) They are outraged by an inadequate governmental response to the pandemic. Depression, anxiety, and suicidal ideation symptom scores did not differ from scores before the pandemic. CONCLUSION: Most older adults with pre-existing MDD show resilience in the first 2 months of the COVID-19 pandemic but have concerns about the future. Policies and interventions to provide access to medical services and opportunities for social interaction are needed to help to maintain mental health and quality of life as the pandemic continues.

Physical health among people with serious mental illness in the face of COVID-19: Concerns and mitigation strategies.

COVID-19 can worsen the physical health of individuals with serious mental illness, a vulnerable group already facing physical health disparities. COVID-19 is further reducing access to physical health care due to shutdown of services deemed "non-urgent" and overcrowding of emergency services. Management of chronic diseases, highly prevalent in this group, is undermined due to exacerbation of psychiatric disorders, reduction in availability of social support, and worsening of negative social determinants of health. In this commentary, we discuss the challenges experienced by this group and offer mitigation strategies to reduce: (1) inequalities in access to physical health care; and (2) disruptions to the management of chronic physical conditions in the face of COVID-19. Recommendations include coordinated efforts by health authorities, primary and mental health care organizations, researchers, policymakers, and other stakeholders. These efforts should ensure equitable access to physical health care and implementation of innovative programs to protect the physical health of people with serious mental illness during and following the pandemic.

Action at a Distance: Geriatric Research during a Pandemic.

BACKGROUND: "Action at a distance" may be the new norm for clinical researchers in the context of the COVID-19 pandemic that may require social distancing for the next 18 months. We must minimize face-to-face contact with vulnerable populations. But we must also persist, adapt, and help our older patients and study participants during the pandemic. METHODS: Clinical researchers have an obligation to help, and we can. Recommendations for clinical researchers working with older adults during the COVID-19 pandemic are discussed. RESULTS: Implement technology now: Minimize face-to-face contact with participants by utilizing digital tools, such as shifting to electronic informed consent and digital HIPAA-compliant tools such as e-mailed surveys or telehealth assessments. Assess the psychological and social impact of COVID-19: How are participants coping? What health or social behaviors have changed? How are they keeping up with current events? What are they doing to stay connected to their families, friends, and communities? Are their healthcare needs being met? Current studies should be adapted immediately to these ends. Mobilize research platforms for patient needs: Leverage our relationships with participants and rapidly deploy novel clinical engagement techniques such as digital tools to intervene remotely and reduce the negative effects of social isolation on our participants. Equip research staff with tangible resources, and provide timely population-specific health information to support patients and healthcare providers. CONCLUSIONS: We have an opportunity to make an impact on our older adult patients now as this pandemic continues to unfold. Above all, clinical researchers need to continue working, to help as many people as possible through the crisis. J Am Geriatr Soc 68:922-925, 2020.

The COVID-19 Global Pandemic: Implications for People With Schizophrenia and Related Disorders.

The coronavirus disease-19 (COVID-19) global pandemic has already had an unprecedented impact on populations around the world, and is anticipated to have a disproportionate burden on people with schizophrenia and related disorders. We discuss the implications of the COVID-19 global pandemic with respect to: (1) increased risk of infection and poor outcomes among people with schizophrenia, (2) anticipated adverse mental health consequences for people with schizophrenia, (3) considerations for mental health service delivery in inpatient and outpatient settings, and (4) potential impact on clinical research in schizophrenia. Recommendations emphasize rapid implementation of measures to both decrease the risk of COVID-19 transmission and maintain continuity of clinical care and research to preserve safety of both people with schizophrenia and the public.

Anticipating and Mitigating the Impact of the COVID-19 Pandemic on Alzheimer's Disease and Related Dementias.

The COVID-19 pandemic is causing global morbidity and mortality, straining health systems, and disrupting society, putting individuals with Alzheimer's disease and related dementias (ADRD) at risk of significant harm. In this Special Article, we examine the current and expected impact of the pandemic on individuals with ADRD. We discuss and propose mitigation strategies for: the risk of COVID-19 infection and its associated morbidity and mortality for individuals with ADRD; the impact of COVID-19 on the diagnosis and clinical management of ADRD; consequences of societal responses to COVID-19 in different ADRD care settings; the effect of COVID-19 on caregivers and physicians of individuals with ADRD; mental hygiene, trauma, and stigma in the time of COVID-19; and the potential impact of COVID-19 on ADRD research. Amid considerable uncertainty, we may be able to prevent or reduce the harm of the COVID-19 pandemic and its consequences for individuals with ADRD and their caregivers.